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No one can deny that accessories are an ideal way to decorate or even renovate your home. Besides being simple items to add, they had a great impact on the overall look and you can get them easily without spending a fortune to change and beautify your home. One of the important accessories that enhance the value of your home …Read More »
Add value to your home by having a luxury classic kitchen design
Do you think about moving to another home after a while to improve your style of living? If the answer is positive, you have to bear in your mind from now that the kitchen design can add a great value to your home when you want to offer it to sale. What about enhancing your home by a luxury classic …Read More »
The Best Ways to Create Classic and Primitive Homes with a Modern Touch by the Artistic Designs for Living
Finding the best designing team that understands your wishes and vision and then turn them professionally to reality is a confusing issue. Actually, you can trust the team of artistic designs for living whether you intend to build a new home or renovate the existing one. If your home needs a renovation and you are eager to keep certain features, …Read More »
Have elegant and classic wrought iron outdoor furniture
Summer is coming and you now need to create a wonderful outdoor area where you can enjoy the fresh air with your friends. The outdoor area furniture has to be comfortable, functional, durable and withstand any weather conditions and to be elegant and stylish as well. One of the popular choices to furnish an elegant and comfortable outdoor area is …Read More »
Wonderful Classic Young Girl Bedroom Decorating Ideas
Do you need to increase the sense of self-confidence into your young girl and help her feel like a princess? If so, the classic bedroom will be your perfect option and she will certainly spend amusing and relaxing times in the room. The antique classic furniture will add a richness and luxury to your young girl bedroom with their durable …Read More »
Decorate Bathroom Interior Design – Classic and Contemporary
The first thing most of us do in the morning is enter the bathroom to get ready. We later come back from a stressful day that might have been accompanied with sweat from the heat to unwind with a bath. For the vitality of the bathroom and the relaxing effect required from it, careful consideration must be put to decorate …Read More »
Classic Bedroom Interior Design
Decorating a master bedroom is a costly venture even if you tried to limit your budget as much as possible. Since applying a bedroom interior design is not going to happen every day, you must make a choice that you won't regret shortly, a choice that you are confident about. Classic bedroom interior design, got its "classic" name by being …Read More »
Classic Bedroom Ideas – Nothing Beats a Classic Dedroom!
Bedrooms are where dreams take place, where the flame of romance ignite and where you might finally acquire your peace of mind. That in mind, bedrooms are to be designed with a warm and cozy air. Nothing is more warm than nature and in this case wood. Wood is the most popular material for bedrooms especially the classic ones. There …Read More »
Modern Classic Interior Design
Modern classic style is the latest fashion in interior design these days. The classic interior house design originated from the European culture, like Victorian and Art Deco; also the Greek and the Roman are the main inspirations of the classic design. The classic design and the modern design are mixed together and the result was the European modern classic interior …Read More »


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It was a crazy birthday weekend, so my menu planning is a little bit last minute. I'm just stealing meals from the last few weeks, instead of taking the time to try out new recipes. But there were all super tasty, so I'm looking forward to making them again.
Monday: Nachos with the black bean mixture from the Black Bean Fajitas ($5 Dinners) we made last week.
Tuesday: Pancakes and a pancake-cake for the kiddo's second birthday.
Wednesday: Spinach and Feta Turkey Burgers (Allrecipes.com) on the grill. We didn't actually make this last week.
Thursday: Broccoli Cheddar Soup (Lynn's Kitchen Adventures)
Friday: Homemade pizza featuring my breadmachine pizza dough and homemade sauce (AllRecipes.com)
Saturday: Leftover pizza
Sunday: French Toast – it's breakfast for dinner (or brinner as we call it)
Did you know that you can save my recipes in your very own recipe box, courtesy of ZipList? Just click on the link above, under "recipes" to get started. Want to learn more? Hop on over to read about this awesome new feature.

subset: commoncrawl


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Express. Home of the Daily and Sunday Express.
Boss gives opinion on Dimitri Payet's West Ham transfer: Chelsea, Man Utd and Arsenal keen
NEIL LENNON believes West Ham face an uphill struggle to convince Dimitri Payet to remain at the club.
West Ham manager Slaven Bilic revealed yesterday that Payet wants to leave the east London outfit.
Payet only signed a £125,000-a-week contract at the London Stadium last year but says he does not want to play for the club anymore.
He will not feature in tomorrow's (3pm) home clash against Crystal Palace, with Chelsea, Manchester United and Arsenal all interested in the France international.
Teams have turned his head
And Lennon, who in his pervious stint at Celtic oversaw Victor Wanyama's big-money move to Southampton, thinks Payet has passed the point of changing his mind.
"It's player power now, isn't it?" the Hibs boss told Sky Sports.
"It's very difficult for a manager when a player is in that mindset.
Neil Lennon (right) says West Ham will struggle to keep Dimitri Payet
Manchester United, Chelsea and Arsenal want to sign Payet
Hibs manager Neil Lennon says interested teams have turned Payet's head
"But if he's come out publicly and said that then there doesn't seem to be a future for him, unless Slaven can turn him round, or the powers that be at West Ham can talk him round.
"He was one of the best players in the Premier League last season.
"Obviously he had a decent Euros and got a lot of attention. And teams have turned his head.
"It's very difficult once you've gone that far to bring them back again."


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Great news for Shahrukh Khan and Mahira Khan's fans: Pakistan Government gives NOC to Raees
The Uri Attacks by the Indian Government, led to the permanent ban of Pakistani artists in Indian films. In the same way, Pakistan also banned the Indian films to release in their country. But recently, the decision has been taken by officials to lift the ban on all Indian films in Pakistan again. Coming to the news, Shahrukh Khan and Mahira Khan's Raees has been doing good at the box office, all credits to their performances and good content in the film. Now here is some great news for Shahrukh Khan fans and Raees team.
The film is now all set to hit the screens in and around Pakistan country. Yes the Pakistan film board allowed to release Raees in Pakistan and now, the government of the country has also issued an NOC (No Objection Certificate). Only a clearance is awaited by the censor board of Pakistan, It will be out very soon.
Punjab Karachi Board cleared Raees Film Certificate
A source from Pakistan Said "Punjab and Karachi Board have cleared the film without cuts. The Islamabad board is yet to clear the film, and they will be watching it on Monday. After that, the screens for the film will be decided." The chairman of the Pakistan Censor Board, Mobashir Hasan said, "We are going to follow the due process. I would not know about the release date. For that, you should speak to the distributor."


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|17 Jul 2013
I'm going to test the fan in about half an hours time, I'm thinking I could either put the fan on my heatsink or I could use as another exhaust/intake.
I already have one fan in front as an intake, one fan in the back as an exhaust, and already one (loud) fan on my heatsink. Any ideas which position will be best?
I'm thinking I could put it on the heatsink so I could turn down the stock fan via BIOS so its quieter, and put the new/fixed fan so theres a push/pull config and keep it on full RPM as it is quiet enough at full RPM?
|My System Specs
|17 Jul 2013
I would try the P/P configuration first on the CPU and note before and after temps.
|My System Specs
|17 Jul 2013
Desk1 7 Home Prem / Desk2 10 Pro / Main lap Asus ROG 10 Pro 2 laptop Toshiba 7 Pro Asus P2520 7 & 10
Dom I know it is more expense but what about trying a quieter fan on the cooler mate I was thinking this one Noctua.at - sound-optimised premium components "Designed in Austria"! the top dB on this one is just 19dB top whack and I am guessing unless you run the machine at full tilt that would reduce to the claimed 16.9 and 12.6dB's that's pretty quiet
|My System Specs
|18 Jul 2013
I was actually asking Britton about those Noctua fans on his cooler (same as mine), but the colour scheme, ugh... make me feel sick...
I was looking at this fan because I like Akasa and that particular model uses the same design as their Venom line so more CFM (also because they're black, and also because of their amazing 16 dB max volume!).
I have mounted the fixed fan so there is now P/P, but because of inconsistent ambient temps here (ranging 22/28 degrees C) I cannot give reliable before/after temps. I do think that the maximum temps have been lowered by a couple of degrees though.
I am currently trying to push 4.2 GHz, but of course there is that damn overclocking wall. And I don't want to push voltages too high because of high ambient temps.
I'm going to mark this thread as solved now anyway. Thanks for the help guys!
|My System Specs
|18 Jul 2013
Good job and yes premium fans are worth it in the short and long term. Silence is golden and silence with performance is stellar !
|My System Specs
|18 Jul 2013
Desk1 7 Home Prem / Desk2 10 Pro / Main lap Asus ROG 10 Pro 2 laptop Toshiba 7 Pro Asus P2520 7 & 10
Sorry I know late reply but I have used hese in the pastand they are good and quiet
ARCTIC F Pro PWM · Case fans · Cooling · ARCTIC
|My System Specs
|19 Jul 2013
Those are only £4.99 here compared to £10 for other brand fans, seems like a good deal!
|My System Specs
|Thread Tools
|Similar help and support threads
A Couple of RAM Questions
Hi, I apologize in advance for this really long post and I know these questions were asked a million times, but I can't seem to find anything accurate through search. Recently, only 8GB of RAM became usable from the 12GB (4x3 Corsair Dominator 9,9,9,24 1.65v) I have installed. After testing...
|Hardware & Devices
Couple of questions
Hello, The thermal paste on my H70 does not seem be performing as well as it was. Can anyone suggest a could thermal paste to use. Also a good fan controller for my 6 fans Many thanks :) .
|PC Custom Builds and Overclocking
Couple of questions that i want to ask
Hi guys. Okay, I am going to start with my laptop specs: MSI FX600 Intel core i5 460m (not oc'ed) 4gb of DDR3 1066mhz ram nvidia geforce gt325m(for physx) and intel hd video(for desktop) 500gb 5200rpm WD sata2 hdd Windows 7 x64 ultimate OS
|Performance & Maintenance
A couple of questions.
I built myself a new computer and installed Win7 64 bit OEM on the 1 tb drive. Disk management will not let me shrink the C drive any smaller than 1/2 tb. I would like to shrink it to 100 gigs and create several smaller drives. Is there any way to do this. It would not be a big problem to start...
|General Discussion
A couple of questions
1) When I turn off my PC at night, which I do every night, should i turn the power button on the back off my PSU off as well? Or should this be left on? 2) My hard drive has recently begun to make very light, and what seems like, scratching noises. It only seems to happen when data is being...
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Couple of questions
hi guys, hope you can give me the answers i've been looking for. first of all, is it possible to make the folder background transparent as well as the border? i know windowblinds has this as an option in some themes, so there must be some kind of dll tweak that can enable it. second, the...
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The fear of intimacy can be found in many relationships today and on many levels. Fear of intimacy
can be related to sexual activities in which one of the partners is afraid to show their body or
avoiding sex. it can be emotionally related, in which one of the partners can't open their soul and
their mind. There are many causes to this problem, but we need to find a way to overcome it as
intimacy is very important to keep your marriage going strong.
Gaining your partners trust is the first step to overcome the fear of intimacy, if it
already developed. You need to show your partner that they can trust you. If you
don't want it to take too long, you can use those trust tests, like having your
partner plunge with their eyes closed and they need to trust you to catch them.
I know this probably sounds stupid right now, but when you are up against the
fear of intimacy you need to try anything.
If trust didn't work, good communication might help in this issue. It is very possible that the
fear of intimacy was caused by some traumatizing event in your partner's life and sexual
harassment and physical abuse may also contribute to depression or anxiety .That is why they
prefer that they aren't naked in your presence. You can reassure them that you will never do
anything to hurt your partner. Of course, talking alone will not work as you expect, so start
showing that you care and that you are honest with your partner.
Talking about one disturbing moment in your life might help your partner to better identify with
you and cause them to open a bit and feel safe around you. Fear of intimacy can be cured in time,
when your partner starts to fully trust you and to see that you are honest about both your feelings
and about other things. Remember that you need to combine these three elements to help your
partner solve their anxiety.
If you manage to be supporting and caring about this problem, you will also see that when the both
of you start your sex life she is more relaxed and focused on the task ahead. She will probably even
get orgasms.
It is indeed funny how a negative situation can be turned into a positive one with a bit of tender
love and commitment . The mistakes that people make in their relationships, even they love
their partners, is that they are not supportive. Whenever something is wrong with their partners,
most of us run for the woods because we don't want to have to deal with. We would rather break
up and maybe find someone that is more stable from an emotional point of view. I really think
that we would have far more benefits into a relationship that we really get ourselves involved in.
Remember that fear of intimacy is not caused by you, but you can't just let it cure on its' own, you
need to be there and support your partner. In time, you will have the perfect relationship
even if right now it isn't that good.
Read Similar Posts:
Achieving Female Orgasm- The Number One Mistake That Leads To Marriage Failure.
A Right Love Making Techniques Is The Key Point To Break Up Women Sexual Dysfunction.


text:
Sign-up HERE to receive a free Fated Bonus Bundle before the form closes.
The gift card winner and 30 phone chat winners have been selected, but there's still a few more days to sign-up for the free Fated Bonus Bundle. I'm putting the final touches on. We've got a colorful pack of extras:
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text: Can anyone post a picture of a standard A2 front sight with something like an aimpoint or eotech optic mounted? I'm trying to get an idea of the sight picture with both the A2 sight and the optic co-witnessing. In my mind it seems like it would be hard to get used to...did anyone have any problems with it?


text:
The Epiphone Masterbilt DR500M Acoustic Guitar delivers unsurpassed sound quality at an amazing price. The quintessential flat-top, the DR500M features the ultimate marriage of tonewoods. A solid Sitka spruce top and solid mahogany back and sides compliment a comfortable bound 25 1/2 inch scale neck, producing the classic dreadnought experience - rich, powerful sound and exceptional playability. Plus, this combination gives you a nice even tone and a smooth feel. Other features include body and neck binding, split diamond inlays and nickel hardware.
What started as a simple string and pedal sales catalog has grown exponentially over the past thirty years. The early days were a time where catalogs didn't have much of a presence in the industry, but what began as a college dorm room operation grew rapidly. In 1986 we moved to a full product offering and 64-page catalog, which over the years has grown to 162 pages. Join the AMS family and get your free catalog now!
Copyright © 1996-2017 American Musical Supply, Inc. All rights reserved. American Musical Supply reserves the right to correct pricing and/or product specifications in the event of typographical errors found in our print catalog or on our website. If a product is listed at an incorrect price due to such errors or because of inaccurate information received from a supplier, American Musical Supply shall have the right to refuse or cancel any orders placed, whether or not the order has been confirmed and your credit card charged. If your credit card has already been charged for the purchase and your order is canceled, American Musical Supply will issue a credit to your credit card account in the amount of the charge.


text:
Crews worked hard to keep victim alive
DUPLIN COUNTY � A Kinston man out on the water of Maxwell�s Mill Pond fell out of his vessel shortly before 6 p.m. Thursday, dying before EMS and rescue personnel could resuscitate him.
The victim is identified as Solomon Henderson, 70.
�We were called to a possible drowning ... and when we got there, there was a fella in the water,� Pink Hill Volunteer Fire Department Chief Timmy Kennedy said of Henderson. �Somebody from the campground had already found the guy, did CPR, and we did CPR on the banks of Maxwell�s Mill Pond, until the paramedics said there�s no action taking place.
�Me and my crew, along with Duplin County Sheriff�s Office and the Duplin County medics that were on scene � we all did CPR until we couldn�t do it anymore.�
Duplin County Sheriff Blake Wallace confirmed scanner reports Henderson had been fishing in a vessel similar to a kayak or canoe when he fell into the water.
�The medical examiner will make that final determination � that�s what it appears at this time,� Wallace said of the unofficial theory Henderson drowned in the pond. �There were witnesses on the scene that actually saw Mr. Henderson flailing in the water. So, it appears that it�s a drowning, but the medical examiner will make that determination.�
Wes Wolfe can be reached at 252-559-1075 and firstname.lastname@example.com. Follow him on Twitter @WolfeReports.


text:
A matcha whisk holder is designed to keep your whisk in great shape. These holders are a lovely jade green celadon.
Celadon is another name for greenware. Celadon glazing originated in China, and later spread to Korea, Japan and other parts of Asia.
Good to know: a matcha whisk holder is the best way to store your whisk as they allow air to circulate around the tines. This helps to keep the whisk odour-free and dry.
Whisks sold separately.
Submit your review
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text:
Sean Cody
Charles & Pavel (Bareback Flip-Flop)
Pornstars: Charles (SC),Pavel (SC)
About this Video:Read Site's Review
I was really excited to have Charles back. Little did I know that he had shaved his body for a "natural body building" competition.
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text:
The Internet of Things (IoT) is now one of the most exciting and fast growing areas of telecoms. Download Developing Telecoms' Special Report on the Internet of Things (IoT) here.
This report examines the rapid development IoT services and technology and considers the unique ways in which IoT will have an impact in developing regions. Originally viewed as mainly for developed countries, it is now clear that emerging markets are enthusiastic adopters of IoT technology. Government services, utilities and enterprises are leading global innovation in areas such as smart cities, healthcare and distribution. Produced in association with Oracle Communications, this report includes articles from Ernst & Young, Creative Intellect Consulting, Arab Advisors and Orange.
Format: PDF - Length: 30 pages - Size: A4
Data Protection
Personal data you supply is stored subject to the UK Data Protection Act, 1998 and other applicable data protection legislation and may be used for direct marketing purposes. If you do not wish your details to be used in this way, please contact The Data Manager: info[@]developingtelecoms[.]com.


text:
Ron Paul: The Cold War Is Over, Let's Start Trading with Cuba
2) That means the Gentiles in the U.S. are, as we
speak, having their freedoms intensely limited ! One very
wise and educated gentleman named Alan Sabrosky uses a very
effective method to uncover who was really behind the 9/11
attacks and he points out, Who is most likely to benefit
from the activity in question, in this case, the creation of
a scenario where Gentiles are the recipients of such
3) This is a question which all people are about
to be able to answer correctly beyond a shadow of a doubt !
The answer to this question is a single puzzle piece, if you
will, that completes a picture previously and very
deceitfully hidden from being viewed by the American public
and by most Israeli Jews, because who, in their right mind,
would support anyone that is bent on the demise of our own
country !
4) Yet we have been doing exactly that in the U.S.!
As you will see from your investigations at your computer,
we clearly need to do some serious pest control in the US !
YouTube these 2 items please: 1) Brother Nathanael
2) Doreen Dotan .
To those making comments about the Illuminati: Please shut up. Not every freaking thing is associated with that. We all know the top wealthy elite do want control over practically every aspect of our lives, but that doesn't mean you can scream Illuminati at everything. Think logically…
The Illuminati got you by your balls, sheep!
Ron Paul is an Illuminati double agent.
Because it's all just a big manipulation theater. They own every power on the earth.
Nobody get's a position this high without their permission. Just like with Obama, it was to give hope to the dumb sheep, until that hope gets weakened by broken promises and then they find another clown to keep people in check, a never ending cycle.
watch this, and you'll know who is the real master of EVERY secret society on the planet.
paranoid schizophrenia
word of wisdom\Ron Paul.
Do not worry, the enemy is self destructing as we speak ! We are only paying attention to them that they be saved. For a world with some people suffering, is a world no one wants. If we wish that our enemy suffer, we are no different than they are. There are an infinite number of untold benefits to loving all people !
Ron Paul or stfu
What makes you say that?
Becareful what you say Arizona cause u could offend someone and go to jail ..
Is RP still taking money pretending he actually has any relevance? Why is he still running? Nobody supports him except the lunatic fringe…5% does not win elections
You know RON PAUL wont sell you out like the other politicians do!!
sleezy guy in beginning almost jacked it up
hey same here after watching that!
RESTORE AMERICA NOW- That is the campaign slogan. It could also be, Remind America Now. Because after four years of Ron Paul, no matter how much of his agenda he might accomplish. Those four years will: Remind future presidents how to be president. Remind congress and future congressmen how to do their jobs. Remind the American People what to expect from their president and congress, let alone themselves.


text:
If you are considering going for penis surgery, a lot of questions are on your mind. Here, we will try and respond to some of these issues so that you can make an informed decision.
It's normal and very considerate for you to wonder whether or not penile surgery is safe or not. Like any of type of surgery, male enhancement surgery is associated with specific risks. Such risks include extended bleeding (that must be controlled in time), infection, and scarring, erectile problems as well as reduced penis sensation during sexual intercourse. Of utmost importance, however, is to choose an experienced, talented and reputable surgeon. It is advisable that you inspect his facilities and his past surgeries to ascertain his credibility. A good doctor is among the most important factors that must be kept into consideration when considering penis enlargement surgery.
How long am I supposed to rest from work after penis enlargement?
For individuals who engage in non-manual work, they are required to rest for approximately two to three days after the surgery. However, if you usually engage in manual work, then, stay off work for at least one week. This is imperative to facilitate proper and quick recovery. It will also help you to avoid possible penis injuries that can happen in the course of your work. You may want to consider keeping your activities to the minimum. For instance, if you leave alone, ensure to do your groceries before penis enlargement surgery, and most importantly, fill your fridge with all the necessities you need for at least one week.
Is the surgery painful?
Having A Small Penis? Try Out These Sex Positions For Small Penis.
Want To Solve Your Small Penis?
Penis Enlargement or Penis Straightening
A good number of patients claim to have experienced moderate or very minimal pain a few days after the surgery. There is no cause for worry though; you may take the pain medication prescribed by your surgeon. It will go a long way in assitisting you to manage pain.
Is penis enlargement surgery expensive?
That depends on several factors namely, the reputation of the surgeon, the clinic standards and its location as well as the nature and type of penile enlargement surgery. Specifically, penis lengthening surgery is more expensive than surgery meant to increase the penis girth. however, you will be required to pay more when you want both increased penis girth and length. On average though, you could spend between £3000 and £5000. Of the essence is to choose a good surgeon since your safety and penis enlargement goal accomplishment must be a priority.
Must I be circumcised prior to undergoing penis enlargement surgery?
Circumcision doesn't come into play when it comes to penis lengthening. However, one must be circumcised first before penile thickening surgery is performed. It is important for you to understand this early in advance so that you can finally make an informed decision. Both types of penis enlargement surgeries can be performed at the same time. In just a single session, you can attain both increased girth and length.
Although this isn't a comprehensive list of the entire penis enlargement frequently asked questions, I hope that you now know what to expect.ASK US A QUESTION
We know when you are thinking about a penis enlargement routine, you have lots of questions. Above, you'll find answers to some of the most common. All these questions are submitted by our visitors. However, if you have any other questions, don't hesitate to ask.
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text:
Senior Research Fellow in International Relations, DPIR, Emeritus Fellow St Antony's College
Research topic: Political Psychology/International Relations
Departmental Lecturer in International Relations, Lecturer in International Relations at New College
Research topic: The Non-Aligned Movement and the Legitimate Use of Force
Senior Research Fellow- Project on Individual Liability in War
Associate Professor of African Politics, Official Fellow of St Peters College
Professor in International Relations, co-director of the Oxford Institute for Ethics, Law and Armed Conflict, Fellow of Somerville College
20th Jun 2017
read more
9th Dec 2016
22nd Sep 2016
10th Mar 2015
13th Feb 2015
On 5 February the House of Commons Defence Committee published a report, The Situation in Iraq and Syria and the response to al-Dawla al-Islamiya fi al-Iraq al-Sham (DAESH). Adam Roberts' evidence to the Inquiry is mentioned in the report, paragraphs 23, 66 and 106.
1st Dec 2014
Research project


text:
Wipro's Earnings Surge 46%, Aided By Large Orders
MUMBAI -- Wipro Ltd., India's third-largest software exporter by sales, said net profit for its second quarter rose 46% despite a squeeze on operating margins as large outsourcing orders offset rising wage costs.
While Wipro expects an increase in its global software-services revenue for the third quarter, operating margins will be hurt by an increase in salaries, it said.
Net profit for the quarter ended Sept. 30 rose to seven...


text:
Go pro.
Vans is getting technical with its new UltraRange sneaker.
Marking a major milestone in Vans' footwear design history, the new silhouette offers an innovative twist on the brand's much-loved skate shoe.
Taking collaborative insight from Vans pro surfer, Pat Gudauskas, the UltraRange is designed to have maximum versatility and comfort.
It features a slim profile, low top design with breathable textiles and a sock-fit construction. An iconic side stripe pays homage to the rich history of the brand.
The Vans UltraRange is available nationally from Vans concept stores and selected Platypus Shoes and Hype DC stores from Saturday.


text:
If you want to prepare your child for a future on the crocodile planet, Space Center Houston has you covered with ''CHOMP! The Science of Survival.'' (A crocodile planet is just one of many alternative-reality futures that those of us in the know are preparing for.) The exhibit brings the world of crocodilians to Space Center Houston for what are being called ''nose-to-snout'' encounters. The event is being handled by Crocodile Encounter, which, in addition to introducing schoolchildren to their favorite carnivores, recently brought a traveling exhibit to a screening of Alligator at Alamo Drafthouse. Here the company has partnered with Space Center Houston and will have multiple croc pools on exhibit along with stage shows throughout the summer.
If crocs aren't your thing, check out the exhibits with poison dart frogs, snakes and sharks on the outdoor stage. There will also be an animal-themed obstacle course for kids involving maneuvering through spider webs and balancing on platforms. (Gotta get them ready for that crocodile planet.)
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9 a.m. to 7 p.m. daily. Through September 2. 1601 NASA Parkway. For information, call 281‑244‑2100 or visit spacecenter.org. Free with paid general admission.
Mondays-Sundays, 9 a.m.-7 p.m. Starts: July 15. Continues through Sept. 2, 2013


text: So Snapchat has chosen to celebrate 4/20 with a totally advisable Bob Marley filter that gives you blackface and dreadlocks. They'll be pulling it and humbly apologizing any time now; I am typing this as fast as I can. Anyway, here are some experiments I've conducted. Thank you for your time, which I realize is valuable. I wish I could say the same.


text:
Andrew's strep throat culture came back negative so he stopped taking the antibiotics. The only other explanation for his reddened, white patched mouth is thrush. He'll take 4 days of an anti-fungal pill as well as an anti-fungal swish and swallow. Andrew's sodium is still low, so the more he drinks the more he pushes fluid out of his cells and essentially dehydrates himself. He will have to just take sips of liquids and suck on lemon drops. His kidneys look great, so that's good news.
Our sister Martha is visiting him today and she said he seems to be having a good day.
Happy Weekending!


text:
US President Donald Trump fired his acting attorney general for refusing to defend his executive order on refugees and immigration. State Department seniors and Silicon Valley have also voiced alarm at Trump's approach to governance.
US President Donald Trump fired the federal government's top lawyer Sally Yates on Monday after she defied the White House and refused to defend new travel restrictions targeting seven Muslim-majority nations.
Yates said late on Monday that the Justice Department would not defend in court Trump's directive on a travel ban, as it was inconsistent with the DOJ's "obligation to always seek justice and stand for what is right."
Firing Yates, the White House said the country's top lawyer had "betrayed the Department of Justice by refusing to enforce a legal order designed to protect the citizens of the United States."
The White House nominated the US Attorney for the Eastern District of Virginia, Dana J. Boente, as Yates's replacement.
On Monday, Trump's administration also replaced Daniel Ragsdale, the acting head of US Immigration and Customs Enforcement (ICE) with Thomas D. Homan. No reason was given for Ragsdale's departure.
Opposition to 'governance by decree'
Trump's 'governance by decree,' has triggered a broad front of opposition among US power centres:
- Federal judges blocked deportations
- Washington state filed a lawsuit arguing Trump's order is unconstitutional
- Several Democratic state attorneys general are considering legal action
- State Department officials circulated a draft memo dissenting on Trump's edict on immigration
- Top Silicon Valley tech executives oppose the Trump ban and are meeting on strategy
TRT World's Kevin McAleese and Tetiana Anderson have a full round-up of the latest from Washington DC.


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I recently decided that I love Valentine's Day. It's never really been my thing up until now because it's usually associated with all things mushy and sappy and romantic... and I am the exact opposite of all of those things. I think the smell of flowers is disgusting and the thought of going out to eat at a restaurant surrounded by hundreds of other people literally makes me want to cry. (This is all very fortunate for Zach who honest-to-goodness doesn't know when Valentine's Day is.)
While I'm not much for stereotypical sappy-romance love, I am ALL about the "you're absolutely fabulous and YOU ARE DOING SO GREAT AT LIFE" gal pal love, hence why I really got into making valentines for some of my favorite girl friends this year. I mean, what lady doesn't need some more sassy babe emojis in her life?
Complete with customized hashtags, because #whoruntheworld?
And if I'm gonna go all out with the valentines and heart-shaped confetti, I might as well doll out the envelopes, right?
Like I said, I had way too much fun with these (which were mailed days ago, but are still en route due to this east coast blizzard. Fingers crossed that they all arrive by tomorrow, but I couldn't wait any longer to share!)
Happy Valentine's Day to everyone out there being super fabulous and doing so great at life! You are loved, friend. Regardless of your stance on Valentine's Day and all things sappy, I heart your face. XO.


text:
Don Massey Collision Center
Featured Business
Collision Center of Peoria9190 W. Bell Rd
Peoria, AZ 85382
37.0 miles away
09/15/2016 - "Great place!!"
"Definitely recommend this place to anyone in need of a car repair! They will take care of you in your..."
Review for Don Massey Collision Center
Kathy Y. on 04/30/2011
Kathy said she was surprised her vehicle was finished so quickly. Ever since she walked into this business she was treated very nicely. Jason is amazing and she is also very satisfied with her salesman, Roger.
Category: Collision
Service Date: 04/21/2011
Review Created: 04/30/2011
This review was collected via phone interview by Customer Research Inc.


text:
I got a new Lexus and wanted to swap the regular wheels for chrome. Although Mike @ Newport Wheel works mostly on Mercedes and other high-end cars, he was enthusiastic about help...
I had questions after I had my wheels installed. Owner never returned my calls. He demands cash for payment so I have no recourse now!
Pros: Price
Cons: Customer Service
From family friendly trips with kid friendly activities to local plumbers lawyers, spas, and contractors. Judy's Book has millions of listings and reviews for the best and not so great. Whether you're looking for a specific business or just trying to discover great places we make it easy. We're a family oriented site focusing on bringing trusted reviews and recommendations to moms and others. Green and Sustainable places are becoming more relevant to Judy's Book users, have a favorite place? Write a review and tell users why it's Green!


text:
Got an idea?
At Arc, we've got the know-how and funds to accelerate you from prototyping, to professionalising. FounderLab provides you with technical expertise in coding, website development and business development so you can focus on leading your startup. We've also got seed-funding to support you through the MVP Fund, and plenty of alumni success stories to keep your spirits up. Being an Arc Member means your can start disrupting sooner, inventing faster and commercialising better.


text:
The Everbilt 2-1/2 in. Hook and Eye is ideal for latching gates, doors, and screens. Its versatility allows for both indoor or outdoor use. Easy to install.
California residents: see Proposition 65 information
- Made of steel
- Bright brass finish
- Screws easy into wood
- Great for indoor or outdoor use
- Ideal for latching doors, screens, cabinets and gates
- For interior and exterior use with doors 1-3/8 - 1-3/4 in. thick
- Note: Product may vary by store


text:
Latest Event Updates
Lanabecestat (formerly known as AZD3293 or LY3314814)
- Molecular FormulaC26H28N4O
- Average mass412.527 Da
Dispiro[cyclohexane-1,2′-[2H]indene-1′(3′H),2"-[2H]imidazol]-4"-amine, 4-methoxy-5"-methyl-6′-[5-(1-propyn-1-yl)-3-pyridinyl]-, (1α,1′R,4β)-
- (1α,1'R,4β)-4-Methoxy-5"-methyl-6′-[5-(1-propyn-1-yl)-3-pyridinyl]dispiro[cyclohexane-1,2′-[2H]indene-1′(3'H),2"-[2H]imidazol]-4"-amine
- (1,4-trans,1'R)-4-methoxy-5"-methyl-6′-[5-(prop-1-yn-1-yl)pyridin-3-yl]-3'H-dispiro[cyclohexane-1,2′-indene-1′,2"-imidazol]-4"-amine
- (1r,1'R,4R)-4-methoxy-5"-methyl-6′-[5-(prop-1-yn-1-yl)pyridin-3-yl]-3'H-dispiro[cyclohexane-1,2′-indene-1′,2"-imidazol]-4"-amine
Lanabecestat (formerly known as AZD3293 or LY3314814) is an oral beta-secretase 1 cleaving enzyme (BACE) inhibitor. A BACE inhibitor in theory would prevent the buildup of beta-amyloid and may help slow or stop the progression of Alzheimer's disease.
In September 2014, AstraZeneca and Eli Lilly and Company announced an agreement to co-develop lanabecestat.[1] A pivotal Phase II/III clinical trial of lanabecestat started in late 2014 and is planned to recruit 2,200 patients and end in June 2019.[2] In April 2016 the company announced it would advance to phase 3 without modification.[3]
- OriginatorAstex Pharmaceuticals…
View original post 5,870 more words
A review of fungal contamination in pharmaceutical products and phenotypic identification of contaminants by conventional methods
A review of fungal contamination in pharmaceutical products and phenotypic identification of contaminants by conventional methods (PDF Download Available). Available from: https://www.researchgate.net/publication/275335972_A_review_of_fungal_contamination_in_pharmaceutical_products_and_phenotypic_identification_of_contaminants_by_conventional_methods [accessed Jun 12, 2017].
Any pharmaceutical product, whether manufactured in the hospital or industrial environment, has the potential to be contaminated with microorganisms. With sterile products, any microbial contamination presents an unacceptable risk; with non-sterile products, the implication of the contamination is dependent upon whether the microorganism can be considered 'objectionable', and then to the extent that it can cause patient harm (and here a risk assessment is ordinarily required)1.
There are different types of microorganisms associated with product recalls. At this stage into the 21st century, fungal contamination of nonsterile products is one of the major reasons for product recalls, production shutdowns, and losses in labour and manufacturing. This can result in a reduced shelf life by compromising product integrity or present potential health hazard to patients2. Many of the reasons are due to the lack of quality control, process control and proper testing.
Most reports relating to the contamination of pharmaceutical products centre on bacterial contamination rather than fungi. The reasons for this may relate to few 'microbiology' laboratories in pharmaceutical organisations having trained mycologists; to an underestimation of the association between fungi and product contamination incidents; and due to a lack of appreciation of the risks that fungi can pose to cleanrooms and controlled environments3. This article considers some of these issues and, in doing so, argues that the contamination risk posed by fungi to pharmaceutical products is greater than the level of industrial and academic interest would suggest.
Fungal contamination risks
Fungi are more evolutionarily advanced forms of microorganisms, as compared to the prokaryotes (such as bacteria). Fungi are commonly divided into two distinct morphological forms: yeasts and hyphae (or filamentous). Yeasts are unicellular fungi which reproduce asexually by blastoconidia formation (budding) or fission4. Fungal contamination in pharmaceutical products represents a potential hazard for two reasons. First, it may cause product spoilage; the metabolic versatility of fungi is such that any formulation ingredient from simple sugars to complex aromatic molecules may undergo chemical modification in the presence of a suitable organism. Spoilage will not only affect therapeutic properties of the product but may also discourage the patient from taking the medication. Second, product contamination represents a health hazard to the patient, although the extent of the hazard will vary from product to product and patient to patient, depending on the types and numbers of organisms present, the route of administration, and the resistance of the patient to infection. https://www.europeanpharmaceuticalreview.com/24118/topics/microbiology-rmm/fungal-contamination-pharmaceutical-products-growing-menace/
Tim Sandle
Microbiology, Biotechnology
Vijayakumar Rajendran
Immunology, Biotechnology, Mycology
Report from the EMA-FDA QbD pilot program
Report from the EMA-FDA QbD pilot program
In March 2011, the European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) launched, under US-EU Confidentiality Arrangements, a joint pilot program for the parallel assessment of applications containing Quality by Design (QbD) elements.
The aim of this program was to facilitate the consistent implementation of QbD concepts introduced through International Council for Harmonisation (ICH) Q8, Q9 and Q10 documents and harmonize regulatory decisions to the greatest extent possible across the two regions.
To facilitate this, assessors/reviewers from US and EU exchanged their views on the implementation of ICH concepts and relevant regulatory requirements using actual applications that requested participation into the program. The program was initially launched for three years. Following its first phase, both agencies agreed to extend it for two more years to facilitate further harmonization of pertinent QbD-related topics.
The program officially concluded in April 2016. During this period, the agencies received 16 requests to participate. One submission was rejected because the approach presented was not limited to QbD applications, and another application was not reviewed because it was never filed by the applicant.
In total, two Marketing Authorisation Applications (MAA)/New Drug Applications (NDA), three variation/supplements and nine scientific advice applications were evaluated under this program. One MAA/NDA was assessed under the parallel assessment pathway, with the rest following the consultative advice route. Based on the learnings during the pilot, FDA and EMA jointly developed and published three sets of Question and Answer (Q&A) documents.
These documents also addressed comments from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), which participated as an observer, offering input to further facilitate harmonization. The objective of these Q&A documents was to generate review guides for the assessors/reviewers and to communicate pilot outcomes to academia and industry.
Additionally, these documents captured any differences in regulatory expectations due to regional requirements, e.g. inclusion of process validation information in the dossier. The following topics were covered in each of the three Q&A documents: –
Q&A (1) published on Aug 20, 2013 included the following topics: (a) Quality target product profile (QTPP) and critical quality attributes (CQA), (b) Criticality, (c) Level of detail in manufacturing process descriptions, and (d) QbD for analytical methods1 –
Q&A (2) published on Nov 1, 2013 on Design Space Verification, that included definition, presentation, justification (including potential scale-up effects) and verification of design spaces both for active substances and finished products2 –
Q&A (3) published on Dec 19, 2014 included the following topics: (a) Level of detail in the dossier regarding Risk Assessment (RA), (b) Level of detail in the dossier regarding Design of Experiments (DOE) and Design Space3 R
Additionally, the FDA-EMA pilot provided the agencies an opportunity to harmonize regulatory expectations for the following precedent-setting applications that were reviewed under the consultative advice pathway: – The first continuous manufacturing (CM) based application submitted to both agencies.
Based on the learnings from this application, the following areas related to CM were harmonized: batch definition; control of excipients; material traceability; strategy for segregation of nonconforming material; real-time release testing (RTRT) methods and prediction models; and good manufacturing practice (GMP) considerations for RTRT, validation strategy, models, and control strategy. – A post approval supplement that included a broad based post-approval change management plan/comparability protocol.
Both agencies were harmonized on the expected level of detail in the protocol and considerations for implementation of a risk based approach to evaluate the changes proposed in the protocol. In line with the scope of the QbD pilot program, joint presentations of key findings were publically presented and discussed with stakeholders at different conferences.
These included the Joint EMAParenteral Drug Association QbD workshop4 organized in 2014 which also included participation from FDA and PMDA.
Overall, it is concluded that, on the basis of the applications submitted for the pilot, there is solid alignment between both Agencies regarding the implementation of multiple ICH Q8, Q9 and Q10 concepts. The FDA/EMA QbD pilot program opened up a platform for continuous dialogue which may lead to further communication on areas of mutual interest to continue the Agencies' support for innovation and global development of medicines of high quality for the benefit of patients.
Both agencies are currently exploring potential joint activities with specific focus on continuous manufacturing, additional emerging technologies, and expedited/accelerated assessments (e.g. PRIME, Breakthrough). Additionally, EMA and FDA are hosting experts from each other's organisations to facilitate dialog and explore further opportunities.
References: 1. EMA-FDA pilot program for parallel assessment of Quality-by-Design applications: lessons learnt and Q&A resulting from the first parallel assessment http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/08/WC500148215.pdf
2. FDA-EMA Questions and Answers on Design Space Verification http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/11/WC500153784.pdf
3. FDA-EMA Questions and answers on level of detail in the regulatory submissions http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/12/WC500179391.pdf
4. Joint European Medicines Agency/Parenteral Drug Association quality-by-design workshop http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2013/12/event_detai l_000808.jsp&mid=WC0b01ac058004d5c3
EMA publishes Q&A on Health Based Exposure Limits – Does the 1/1000 dose criterion come again into play in Cleaning Validation?
In 2014 the European Medicines Agency (EMA) issued the Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities. This publication triggered a discussion about the Permitted Daily Exposure (PDE) values in the Pharmaceutical and even in the API Industry, especially regarding crosscontamination and cleaning validation. Now a draft of a Q&A paper from the EMA provides some concretisation.
In 2014 the European Medicines Agency (EMA) issued the Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities. As mentioned in the publication itself, this document triggered a discussion about the Permitted Daily Exposure (PDE) values in the Pharmaceutical and even in the API Industry, especially regarding crosscontamination and cleaning validation. Now, the draft of a question & answer paper from the European Medicines Agency provides some concretisation of the guideline.
The document altogether comprises five pages with 14 questions and answers.
The questions – and even more the answers – are very interesting, as shown in question 1 already: Do companies have to establish Health Based Exposure Limits (HBELs) for all products?
The answer is: Yes, but there are references to question 2 and 4 (and their respective answers). Question 2 clarifies what products/active substances are considered as highly hazardous. There are, among others, 5 groups listed, which products should be classified as highly hazardous (e.g.compounds with a high pharmacological potency, daily dose < 1 mg/day (veterinary dose equivalent 0.02 mg/kg)). For highly hazardous substances the answer yes in question 1 is expected. Even more interesting is the link to question and answer 4: Can calculation of HBELs be based on clinical data only (e.g. 1/1000th of the minimum therapeutic dose)? And the answer is yes, but only at designated circumstances. This means the products should have a favourable therapeutic index (safety window) and the pharmacological activity would be the most sensitive/critical effect.
Some further clarification regarding LD 50 is provided in Question 5 and the respective Answer: The use of LD 50 to determine health based limits is not allowed.
There are also more questions and answers regarding Veterinary Medicinal Products, the inspection of the competence of the toxicology expert developing HBELs, Occupational Exposure Limits, cleaning limits, Investigational Medicinal Products and paedric medicinal products and about Cross Contamination. Details will follow.
The document is still a draft and the industry has the opportunity to comment it until the end of April 2017. Let´s see what the final version will bring.
Please also see the draft Questions and answers on implementation of risk based prevention of cross contamination in production and 'Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities'on the EMA website.
At ECA´s Cleaning Validation Course, 9-10 February 2017 in Heidelberg, Germany the EMA Q&A draft will also be discussed.
some pics
///////////EMA, Q&A , Health Based Exposure Limits, 1/1000 dose , criterion, Cleaning Validation,
Thailand Drug regulatory Update, Take a peep
[PDF]Regulatory Requirement for the Approval of generic Drug in Thailand …
Apr 13, 2014 – Thailand has its own drug registration format and also follows. ASEAN CTD. … Transparency in the regulatory authorities of member countries.
The Thai FDA (TFDA), one of several agencies under the Ministry of Public Health (MPH), is the regulatory body administering drugs in Thailand. The Drug Control Division of the TFDA is responsible for registration, licensing, surveillance, inspection and adverse event monitoring for all pharmaceuticals and pharmaceutical companies in Thailand. Foreign pharma companies dominate the Thai drug market. Due in part to trade negotiations, regional harmonization and positive economic trends, the pharmaceutical market in Thailand is predicted to double by 2022.There are several versions of the Drug Act currently in effect, and the Thai government is working on a revised version with updated regulations. Under the current laws, pharmaceuticals are categorized as either traditional or modern medicines, with different applications and oversight. Modern medicines are subdivided into three categories, each of which has separate registration requirements. Licenses currently do not require renewal.
FIRST ASEAN COUNTRY WITH A NATIONAL eCTD PROGRAM
Thai FDA intends to accept dossier in eCTD format: The Drug Regulatory Authority of Thailand (Thai FDA) has initiated the acceptance of Pilot eCTD from October 2014.Read More
eCTD requirements
Step to be followed to submit eCTD application
Taken from
Regulatory Scientist at Kinapse
A) Prepare Application to get a eSubmission Identifier for every application issued. A request to the THAI FDA online service should be submitted to obtain an eSubmission identifier which will require following details.
- Licensee Number
- Description of Application
- Dosage Form
- INN or Generic Name
- Strength
- WHO ATC Code
- Sequence Type
- Application form
- CPP (In case of Importer)
The eSubmission Identifier will be issued within 10 days of application. The Applicant must then make an appointment for submission within 30 days.
B) Prepare valid application along with validation reports as per country (Thailand) specific requirement with regional eSubmission Identifier provided.
The M1 requirements to be kept in consideration while compiling the Submission.
- Enhanced granularity for each sections
- Country code is not required in filenames
- Information relating to orphan market is not mandatory
- For LCM (Life cycle management) submissions the Operation attribute should be "Replace" in Tracking Table
- Validation report should be submitted along with the sequence
- 1.3.1 Product Information has been broken down into three specific sections for Labelling, SPC and the Package leaflet. No other product types are expected. If one file is submitted for this section, it should be submitted under 22.214.171.124 Labelling.
- 220.127.116.11 Package Leaflet has been broken down into language sections for English, Thai and Other languages.
- It is recommended that separate files should be submitted for each language.
- Applicants can re-use the content submitted in other regions (including STF).
- The identifier is a combination of a letter and seven digits.
- Working documents are not needed and do not need to be provided within the eCTD framework for Thailand
- Section 1.5.2 "Information for Generic, 'Hybrid' or Bio-similar Applications" has been broken down into three sections and given a section number to make expectations and cross referencing clearer.
- Only one file should be provided for 1.6 Environmental Risk Assessment. It is not allowed to provide content in both 1.6.1 and 1.6.2.
- During lifecycle, 1.8.2 Risk management plan should always use the lifecycle operator replace.
C) Dispatch Activity Delivery of the application at Thai FDA in CD/DVD (make an prior appointment with HA at email@example.com
Thai FDA has proposed a set of media formats to be used while submission of eCTD
- (CD-R) i.e. Compact Disc-Recordable
- Digital Versatile Disc-Random Access Memory (DVD-RAM)
- Digital Versatile Disc-Recordable (DVD+R/-R) recorded
Future Aspect-Import: The eCTD will be validated and imported into the THAI FDA Review System
Feedback: Application feedback (if there are problems experienced during the upload) and review of application by Thai FDA
Ensure that you do not use. 1. Double-sided discs 2. Re-writable disc (protection, authenticity and Stability of information cannot
Ensure that you do not use:
- Double-sided discs,
- Re-writable discs (protection, authenticity, and stability of information cannot be guaranteed)
- Compressed or zipped files (except for validation reports)
FDA publishes Final Guideline on GMP for Combination Products
In the beginning of 2015 the FDA has published a draft guideline about GMP for Combination Products. Now the final version has been published. What are the differences between the draft and the final version of the FDA Guideline for Combination Products?
In the beginning of 2015 the FDA has published a draft guideline about GMP for Combination Products. Now the final version has been published. What are the differences between the draft and the final version? In the following you will find an overview:
The final guideline has expanded to now 59 pages (draft: 46 pages). And also the number of footnotes increased from 85 (draft) to 147 (final).
In the table of content there are one new subchapter (II B Quality and Current Good Manufacturing Practice) and one new chapter (VII Glossary). Subchapter III C was expanded to definitions and terminology. In the following the table of content is listed:
I. Introduction
II. Background
A. Definition of a combination product
B. Quality and Current Good Manufacturing Practices
C. Overview of the final rule
D. The role of the lead center and other agency components
III. General Considerations for CGMP Compliance
A. Demonstrating compliance
B. Investigational products
C. Definitions and terminology
D. What CGMP requirements apply to a product or facility?
E. Control of changes to a combination product
IV. What do I need to know about the CGMP requirements specified in 21 CFR 4.4(b)?
A. Provisions from the device QS regulation specified in 21 CFR 4.4(b)(1)
B. Provisions from the drug CGMPs specified in 21 CFR 4.4(b)(2)
C. Combination products that include biological products and HCT/Ps
V. Application of CGMP requirements to specific types of combination products
A. Prefilled syringe
B. Drug-coated mesh
C. Drug Eluting Stent (DES)
VI. Contact Us
VII. Glossary
VIII. References
In the introduction it is explicitly stated, that "The final rule did not establish any new requirements". In a footnote the guideline gives an explanation why the term "legacy" combination product has not been used.
In the new subchapter II B (Quality and Current Good Manufacturing Practice) the guideline mentions, that "the core requirements embedded in these regulations provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. This includes establishing a strong quality management system, using appropriate quality raw materials, establishing robust manufacturing and control procedures based on sound design principles, and detecting and investigating product quality deviations. In addition, these regulations call for ongoing assessment of systems and the implementation of corrective actions where appropriate".
The final document introduces in Section C the new term "CGMP operating system". This means the operating system within an establishment that is designed and implemented to address and meet the current good manufacturing practice requirements applicable to the manufacture of a combination product. A clarification about constituent parts of cross-labeled combination products is also implemented. Further, there is a new passage about the choice of the GMP-approach (QS regulation vs drug CGMPs) also regarding a streamlined approach and for companies manufacturing different products. Completely new is the passage with the title "Documentation of CGMP Approach". Here you can also find hints that manufacturerers with products that have been on the market since before GMP for Combination Products (21 CFR 4) came into operation, have to be compliant too. The guideline requires that the information about the "CGMP operating system" should be shared with FDA investigators in the beginning of an inspection.
In the "Demonstrating compliance" subchapter (III A) there is additional information about crossreferenced approaches (21 CFR 820 vs 21 CFR 211 and vice versa). For investigational products (III B) you can find more detailed information about exemptions from part 820 regarding 21 CFR 820.30 (Design).
In the Definition and terminology section (III D) there are amendments regarding container closure aspects and kits. Section III D (What CGMP requirements apply to a product or facility?) details the responsibility of the owner of a combination product and CAPA procedures in shared facilities.
In section III E. (Control of changes to a combination product) information for single entity and co-packed combination product manufacturers has been amended. The passages in IV A (Provisions from the device QS regulation specified in 21 CFR 4.4(b)(1) with regard to 21 CFR 820 about Management Responsibility, Design Controls, Purchasing Controls and CAPA have been extended – including examples – and "modernised". Terms like quality oversight and QTTP are now mentioned there. Vice versa the passages with regard to 21 CFR 211, 211.84. 211.103, 211.132, 211.137, 211.165, 211.166, 211.167, and 211.170, (IV B Provisions from the drug CGMPs specified in 21 CFR 4.4(b)(2)) have also been extended – likewise with examples – and have been "modernised" as well (e.g. parametric release is mentioned).
In the example about prefilled syringes (V A) one can find an amended passsage about Design Controls and a new section about Design History File. In the example about drug-coated mesh (V B) there has also been included a new section about Design History File. In the drug eluting stent example (V. C) there are amendments in the section about 21 CFR 211.184, 21 CFR 211.103 and 21 CFR 211.170. Furthermore all examples comprise editorial changes.
Completely new is the chapter VII (Glossary). The number of references (Chapter VIII) increased to 31 (draft: 19).
There are a lot of changes from the draft to the final document. One chapter (Glossary) and a subchapter ( Quality and Current Good Manufacturing Practices) are new, but there are also new passages and amendments in the final document. Helpful are the examples that have been integrated.
Please also see the Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products for more details.
GMP's for Early Stage Development of new Drug substances and products
GMP's for Early Stage Development of New Drug substances and products
|range of colour
|conforms to a reference spectrum
|report results
|97–103% on a dry basis
|NMT 3.0% total, NMT 1.0% each
|follow EMA guidelines (pending ICH M7 guidance)
|follow EMA guidelines (pending ICH Q3D guidance)
|residual solvents
|use ICH Q3C limits or other justified limits for solvents used in final synthetic step
|water content
|report results
|solid form
|report results
|particle size
|report results
|residue on ignition
"ALL FOR DRUGS" CATERS TO EDUCATION GLOBALLY, No commercial exploits are done or advertisements added by me. This article is a compilation for educational purposes only.
P.S. : The views expressed are my personal and in no-way suggest the views of the professional body or the company that I represent
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text:
Demonstrators Marianne and Rebecca
explaining a specimen to student Felicity.
The Biological Anthropology Research Centre (BARC) teaches students at all levels within Archaeological Sciences. In keeping with much of the teaching at Archaeological Sciences, University of Bradford, we focus on a hands-on approach, and include as many laboratories within modules/courses as possible. Our large collection of human skeletal remains is used extensively in the teaching of final-year undergraduates, and masters students. We also have an extensive collection of cast material which is used for teaching anatomy, basic skeletal morphology, primatology and hominid evolution.
Last Updated:01 May 2012


text:
This is it! 2010 is coming to an end and its falling on a weekend. Welcome to this weeks special edition of the Show Locator in our News Years Eve Edition. Usually we make this post every Friday, but in case you guys are wondering whats going on for New Years, we wanted to give you guys an early jump. Check out the years final Friday night & make your plans for New Years Eve!
Happy New Year Pier Massive!
Friday, December 31st, 2010
Tomorrows Bad Seeds, Gabriels Fallen, Fortunate Youth, KAT & Dos Mequis
@ Brixton. Redondo Beach, CA
John Brown's Body & Tatanka
@ Cervantes Masterpiece Ballroom. Denver, CO
Sublime w/Rome & The Dirty Heads
@ Navy Pier. Grand Ballroom. Chicago, IL
Rebelution, The Aggrolites & Stranger
@ House of Blues. Anaheim, CA
BALLYHOO! & Badfish (Tribute to Sublime)
@ Bourbon Street. Baltimore, MD
The Beautiful Girls
@ Falls Festival. Lorne, Australia
Authority Zero, Fayuca & Strung Out
@ Marquee Theatre. Tempe, AZ
The Supervillains & Ovni Sound System
@ House of Blues. Orlando, FL
@ Paddy's. Vail, CO
The Movement
@ Seacrets Resort. Ocean City, MD
The Blackseeds & Katchafire
@ Coro Gold. Whitianga, NZ
Cas Haley & World Tribe
@ Saint Rocke. Hermosa Beach, CA
G. Love & The Special Sauce & WIDESPREAD PANIC
@ Pepsi Center. Denver, CO
Saturday, January 1st, 2011!
T.U.G.G. w/ Vibenhai and H.E.M.P.
@ Bourbon Theater. Lincoln, NE
The Movement & Mambo Sauce
@ Jammin Java. Vienna, VA
GIANT PANDA GUERILLA DUB SQUAD, RootsCollider & Mosaic Fo.
@ Water Street. Rochester, NY
…..Is there a show we forgot to mention?
Or Is your group playing a gig that we dont know about?
Let us know by posting freely in our Pier Forum where you can network with Fans & Artists from the scene.
See you this weekend!


text:
Table of Contents:
Regular Columns
Under the Rose
News from the Line Editor
Who's Who
The Grand Tribunal 2007
Jinn as Characters
Mythic Europe: Real Places
The Path of the Circle
End of the Hohenstaufen Part II
Wheostan the Old
Beasts of the Realm
Templar Apotropaics
Jerod's Cave
News about the release of Art & Academe.
The authors of Sub Rosa.
The 2007 Ars Magica convention.
Jinn as Characters
Ars magica NPC
Malham Cove,
The Path of the Circle was the first written for House of Hermes: Mystery Cults.
The history of the Hohenstaufen.
Ars Magica NPC.
New Ars magica monsters, the Griffin, the Basilisk and the Siren.
This article is the first of the alternate histories of the Templars.
Jerod's Cave is a adventure setting that is designed to provide "story hooks" for your


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Hi! New to the board and have a couple of questions.
We will be visiting Room June 15-21 this year. We have rented an apartment in the Colosseum area (via merulana). There will be my husband, me and 2 grown adult children. We will be relying on walking and public transportation (metro, buses, etc) for our transportation.
We currently live in the caribbean and where ever we go, we prefer to eat where the locals eat, not the tourist restaurants.
We plan on doing breakfast in our apartment, but would love some names of local restaurants for our afternoon meal and something light for dinner (we are Americans, but live in the Caribbean where eat very European, 2 hour break in afternoon for big meal, then light meal after 7pm or so.
Our favorites of course are pasta and seafood. We love to try new things to eat, so we are open to all different types of foods.


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At WGE we are passionate about delivering strong and proactive engineering services. We're specialists in all disciplines from civil to acoustics and sustainability and have extensive experience in a range of sectors such as health & aged care, retail and sports, culture & the arts.
Within the industry we are abreast of new opportunities. Opportunities to transform, to innovate and to reimagine the way we do business. We use advanced Building Information Modelling (BIM) and modular construction techniques to continue to push the boundaries of design on our projects.
This section provides links to each of our engineering disciplines and sector focuses, where you will find more information, key contacts and exciting projects.
Noise in a building can seriously affect the interactions within and around that space. At work, noise can affect our productivity. At play, noise can affect our ability to unwind, rest and relax. At WGE Acoustics, noise is what we know best. Read more
AV systems use various types of video and audio equipment to ultimately deliver a required message or content to a target audience. Read more
It's more than just turning dirt. Civil engineering is one of the oldest engineering disciplines in the world and WGE have been practicing it for well over 50 years. Read more
Electricity is something most of us take for granted. We don't ever really think about it, until of course, we don't have it. At WGE we think differently. Read more
Building fires cause millions of dollars of damage each year. The two major causes are electrical fault and human error. That's why the Fire Engineering team at WGE take their job very seriously. Read more
We give you peace of mind. Whether you're building a football stadium, a tunnel or a commercial building, protecting people in the event of fire, is an absolute priority. Read more
Buildings are complex structures requiring the skills of many engineering disciplines. Yet there's one discipline that's vital to keeping the whole building operational and the people in that building healthy – hydraulics. Read more
It's about comfort not mechanics. We get the solution right from the outset.There really is no project too challenging or too demanding. We thrive on challenges! Read more
There are plenty of engineering consultants out there willing to give advice. But how do you know if it's the right advice or even the best advice? You look for a team with a great track record and who are highly recommended like the WGE Property Asset Management team. Read more
There's no doubt that lighting affects the ambience of a building and its surrounds. A great ambience makes for a positive experience and happy people. That's why it's important to consider the WGE Specialist Lighting team before you start work on your next project. Read more
It's about your vision – we think beyond the structure. Every great design requires a great structural engineering team behind it. No matter how large, complex or unusual your project may be, the hallmarks of a great structural consultant are the ability to deliver innovative, commercially viable and highly buildable solutions. Read more
It's no longer an option to be sustainable, it's an expectation. That's why the companies serious about doing the best they can for the environment are turning to the WGE Sustainability team. Read more
Telecomms & ICT are now a core function in all areas of business, services and in our personal lives. As each year passes, our dependence on ICT grows as ICT capabilities increases exponentially. Read more
It's more than just power. We're experts at telecommunications and NBN services, urban lighting, solar power lighting, power generation, infrastructure master planning and so much more. Read more
Getting people from A to Z. Whether it's a lift or an escalator at a school, retail precinct, commercial building or a hospital, there's nothing our specialist VT team hasn't tackled. Read more
Outstanding commercial buildings require an outstanding design and construction team to make your vision a reality. That's why many of Australia's developers work with the WGE commercial engineering team on their projects. Read more
There's a transformation happening in the world of learning and education. It's no longer just about cultivating enquiring minds. It's about providing a learning environment where the world's social and environmental problems can be solved. That's where our education specialists at WGE come in. Read more
Caring for the sick and the elderly is something that all Australian's aspire to do well and with compassion. State of the art facilities backed by state of the art design enables health professionals to do their job well and give optimal care. That's why WGE are the first choice for health and aged care projects. Read more
Behind the finer things in life, there's a fine engineering company like WGE. Whether you're enjoying the beautiful facilities of a five star hotel or an exquisite meal at your favourite restaurant, chances are one of our engineers is behind it all. Read more
Behind every industrial complex is a highly industrious engineering team. From Perth to Sydney and everywhere in between, WGE has been the powerhouse behind many of the countries industrial sites. Read more
Behind every exceptional city and town there's an exceptional engineering team that built the infrastructure to service it. While the fruits of our efforts are often buried, our impacts are tangible. Read more
Land development is what we do very well at WGE. In fact, we've been partnering with Australia's largest private and public land developers on hundreds of projects since we first opened our doors in 1961. Read more
Places to go, things to do, people to see. The modern lifestyle is a busy one indeed. That's why, at the end of the day, people and families seek a sanctuary in their home. And that's why residential developers choose WGE Residential as their engineering team. Read more
Building a successful retail shopping centre that will attract the best tenants and high traffic is a highly complex job. That's why many of Australia's leading developers, such as AMP, Colonial First State and Stockland, choose the WGE Retail engineering team. Read more
We're a nation that loves our downtime. If we're not at home entertaining family and friends, we're out entertaining ourselves watching our favourite football team or visiting the latest art exhibition. Entertainment is what Australians do well and it's what WGE love to do. Read more
Modern business relies on the ability to reliably retrieve, store, aggregate and disseminate data to service customers and make solid strategic, forward-thinking decisions. It's the engineering behind this technology that keeps the wheels of industry turning. That's why WGE have put together a team of experts specialising in technology. Read more
Technological advances in the construction industry are creating opportunities for WGE. Opportunities to transform, innovate and reimagine the way we do business. Building Information Modelling (BIM) and modular construction are two significant advances that are changing the design process and the speed of construction. WGE are at the forefront of these technologies, shaping the way we use them in our industry. Click below to read more about our knowledge and experiences.
News July 05, 2017
WGE is working with Engineering Education Australia (EEAUST) and Open Learning, on a new training module to inform the management of underground assets or subsurface utilities. Available through Open Learning in July 2017, the read more »
News November 13, 2017
Congratulations to all projects recognised at the Master Builders Australia's NSW Excellence in Construction awards. Announced in early November, the awards are the commercial building industry's most prestigious awards, attracting entries from the state's largest read more »
News November 09, 2017
WGE's Specialist Lighting team have been recognised for their work in the 2017 WA Architecture Awards. The team's lighting design for Woods Bagot's Perth studio received the Mondoluce Lighting Award.
Woods Bagot transformed the heritage-listed read more »


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Fevershan Early Origins
Kent at Faversham, a market town and civil parish in the Swale district which dates back to 811 when it was first listed as Fefresham. By the time of the Domesday Book in 1086, the town was known by the modern spelling of Faversham and Faversaham. At that time, Faversaham consisted of 2 salt houses, a mill and was a market town. Nearby was Faversham Abbey, a Cluny style monastery immediately to the north-east of the town. It was founded by King Stephen and his queen, Matilda I of Boulogne, in 1148. The Abbey was the burial place of the founding king and queen. The Abbey was dissolved in 1538 and subsequently most of it was demolished. The Abbey Guest House has survived and it now a private residence. The place name literally means "homestead or village of the smith" from the Old English words faefer + ham. [1]CITATION[CLOSE]
Mills, A.D., Dictionary of English Place-Names. Oxford: Oxford University Press, 1991. Print. (ISBN 0-19-869156-4)
Fevershan Spelling Variations
Fevershan Spelling Variations
It is only in the last few hundred years that the English language has been standardized. For that reason, Anglo-Norman surnames like Fevershan are characterized by many spelling variations. Scribes and monks in the Middle Ages spelled names they sounded, so it is common to find several variations that refer to a single person. As the English language changed and incorporated elements of other European languages such as Norman French and Latin, even literate people regularly changed the spelling of their names. The variations of the name Fevershan include Feversham, Faversham and others.
Fevershan Early History
Fevershan Early History
This web page shows only a small excerpt of our Fevershan research. Another 365 words (26 lines of text) covering the years 1463, 1465 and 1685 are included under the topic Early Fevershan History in all our PDF Extended History products and printed products wherever possible.
Fevershan Early Notables (pre 1700)
Fevershan Early Notables (pre 1700)
More information is included under the topic Early Fevershan Notables in all our PDF Extended History products and printed products wherever possible.
The Great Migration
The Great Migration
Faced with the chaos present in England at that time, many English families looked towards the open frontiers of the New World with its opportunities to escape oppression and starvation. People migrated to North America, as well as Australia and Ireland in droves, paying exorbitant rates for passages in cramped, unsafe ships. Many of the settlers did not make the long passage alive, but those who did see the shores of North America were welcomed with great opportunity. Many of the families that came from England went on to make essential contributions to the emerging nations of Canada and the United States. Some of the first immigrants to cross the Atlantic and come to North America carried the name Fevershan, or a variant listed above: settlers, who were recorded from the mid 17th century in the great migration from Europe. Migrants settled on the eastern seaboard from Newfoundland, to Boston, to Virginia, to Florida, and to the islands..
Fevershan Family Crest Products
Fevershan Family Crest Products
See Also
See Also
Other References
The Fevershan Family Crest was acquired from the Houseofnames.com archives. The Fevershan Family Crest was drawn according to heraldic standards based on published blazons. We generally include the oldest published family crest once associated with each surname.
This page was last modified on 23 May 2014 at 13:32.
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The 2015 NFL Draft is almost here, and fantasy football owners are already looking forward to drafting "This Year's Odell Beckham Jr." and not drafting "This Year's Johnny Manziel."
While it's tough to evaluate a player's fantasy prospects until we know what team they'll be playing for, it's nice to have some background on each player and know their strengths and weaknesses when their names are called on draft day(s). The following players stand out as having the potential to impact fantasy leagues next year. Check Sporting News Fantasy for analysis of all the key NFL draft picks.
BOOKMARK: SN Fantasy | FOLLOW: @SN_Fantasy
Jameis Winston, Florida State
Winston (6-4, 231 pounds) has the credentials to be a franchise quarterback. The 2013 Heisman Trophy winner compiled a 26-1 record as a starter at Florida State. He threw 40 TDs and 10 interceptions as a red-shirt freshman before throwing 25 TDs and 18 interceptions as a sophomore, but he balanced the turnovers with a knack for making clutch throws in the right situations. Winston would be a no-brainer No. 1 pick if not for a series of off-the-field incidents which included a sexual assault investigation (he was never charged), a misdemeanor charge for shoplifting, and a one-game suspension for yelling at vulgarities in the student union. The upside? A live-arm quarterback who could put up numbers, even for a bottom-feeder franchise. The downside? Maturity issues that can only be answered if Winston doesn't make another misstep. Winston is going to be given a chance right away. He's worth the gamble in two-quarterback leagues.
Marcus Mariota, Oregon
Mariota (6-4, 222) put together one of the most efficient seasons in college football history in 2014: 4,454 yards, 42 TDs, four INTs, 68.3 completion percentage, 750 rushing yards and 15 TDs while leading Oregon to the College Football Championship game and winning the Heisman Trophy. Mariota, however, is still answering questions about playing in a zone-read oriented offense for the Ducks. His skill set is a ready-made match for Chip Kelly in Philadelphia because of his college connections, but Mariota has the talent to be successful for any NFL team. He might need more time to develop in a pro-style offense, but if Mariota starts right away he'll fit in two-quarterback leagues.
Brett Hundley, UCLA
Hundley dazzled as a dual-threat star with the Bruins over the past three seasons, averaging 3,322 passing yards, 582.3 rushing yards and 35.3 TDs per year. Perhaps most important is that his completion percentage went up and his INTs went down each season. With a little seasoning, the 6-3, 227-pound Hundley could become an interesting fantasy prospect in Dynasty Leagues.
Bryce Petty, Baylor
Petty seemingly took a step back last year, but he still put up 3,855 passing yards and 35 total TDs. It's always tough to evaluate quarterbacks coming from pass-happy spread systems like Baylor's, but at 6-3, 230 pounds with a strong, accurate arm, Petty has the potential to put up numbers if and when he eventually gets a chance.
Todd Gurley, Georgia
Gurley might be the most-talented player in the 2015 NFL Draft. That's high praise, but he has the size (6-1, 222 pounds) and speed to be finish in the top 10 in rushing. Gurley averaged 6.4 yards per carry in three seasons at Georgia and was on the way to a monster season in 2014 before it was cut short by a suspension. He also tore his left ACL. If there's a concern, it might be that Gurley hasn't had more than 200 rushing attempts in a single season since his freshman year, but that actually might work out in his favor since he has less tread on his tires. Gurley averaged 151.8 rushing yards through six games last season, and he has the potential to be a game-breaker, even as a rookie. Given the fact Gurley is expected to be drafted in the first round, expectations will soar in fantasy leagues.
Melvin Gordon, Wisconsin
Gordon (6-1, 215 pounds) nearly broke Barry Sanders' single-season rushing record with 2,587 rushing yards in 2014, and it wasn't a fluke. Gordon had six games with at least 200 rushing yards, and he briefly set the single-game rushing record with 408 yards against Nebraska. Gordon also added 29 TDs and averaged 7.5 yards per carry. Gordon's trademark is speed, but he wasn't much of a factor in the Badgers' receiving game (19 catches, 153 yards). Gordon ran a 4.52 in the 40-yard dash at the NFL Combine, a time that was slower than expected. Still, expect Gordon to be drafted in the first round, and he'll either be the first or second rookie drafted in most fantasy drafts along with Gurley. Gordon could fit in as a RB2 or flex play right away.
Duke Johnson, Miami
Johnson starred as a do-it-all back for Miami, where he compiled 2,073 total yards and 13 TDs as junior. He also ranked fourth among backs with at least 200 carries with 6.8 yards per rush. Johnson (5-9, 207 pounds) ran a 4.54 in the 40-yard dash at the NFL Combine, and he's good enough out of the backfield (38 receptions, 421 yards) to be a feature back right away if he lands in the right spot. Johnson isn't the biggest back, but he's a tougher inside runner than you think. He's a notch below Gurley and Gordon, but the gap isn't significant.
Tevin Coleman, Indiana
Coleman (5-11, 206 pounds) proved the ultimate home-run hitter in Indiana's spread offense, and it led to some ridiculous totals. Not only did Coleman rush for 2,036 yards and 15 TDs last season, and the average distance on those TDs was an incredible 40.3 yards per score. Coleman didn't run the 40-yard dash at the NFL Combine, and he averaged just 22 receptions the past two seasons. He would be a better fit in an offense that utilizes more shotgun sets, but his ability to break off the long touchdown will make him an enticing late-round flier in 2015. He consistently produced against stiff competition.
Jay Ajayi, Boise State
For those that must make into the comparison to former Boise State running back Doug Martin, Ajayi is bigger (6-0, 221 pounds) and put up better numbers in his final two seasons with the Broncos. Ajayi's 40 time (4.57) isn't all that different than Gordon's (4.52). Ajayi rushed for 3,248 yards and 46 TDs the past two years, and he had 50 receptions as a junior. Ajayi comes cheaper than Gordon or Gurley on fantasy draft day, but depending on the situation he might lead all rookies in rushing yards and TDs. Remember how prolific Martin was as a rookie?
T.J. Yeldon, Alabama
Yeldon is the next in the line of Alabama's assembly line of NFL running backs under Nick Saban, but he doesn't come in with nearly as much fanfare as Mark Ingram, Trent Richardson or Eddie Lacy. Yeldon (6-1, 226 pounds) quietly produced an average of 1,111 yards and 12 rushing TDs the past three seasons for the Crimson Tide, but his numbers took a hit in Lane Kiffin's more pass-friendly offense as a junior. Yeldon's 40-yard dash time of 4.61 leaves a lot to be desired, and he won't open as a starter. Still, he was a consistent player in the SEC. As a rookie, Yeldon figures to be a handcuff who will add depth to a fantasy roster.
Ameer Abdullah, Nebraska
Abdullah nearly broke Mike Rozier's all-time rushing record at Nebraska. Abdullah finished with 4,588 yards the past four years, and he added 690 receiving yards. Abdullah doesn't have prototypical size (5-9, 205 pounds), and he ran a 4.60 in the 40-yard dash. He's still a decisive runner and proved a durable playmaker for the Cornhuskers, and he'll get a shot as a rotation back as a rookie. Abdullah's track record is proven, and he'll be a value pick for running back hunters in the later rounds.
David Johnson, Northern Iowa
Here's your FCS flier that will get some attention in the preseason, much like Cleveland's Terrence West did in 2014 -- only Johnson is bigger (6-1, 224 pounds), and he ran a 4.50 in the 40-yard dash at the NFL Combine. Johnson not only strung together three consecutive 1,000-yard seasons at Northern Iowa, but he also had 30-plus receptions all four years. Johnson's senior season – which entailed 2,086 total yards and 19 TDs – suggests he can play at the NFL level. He also had 138 yards in a win against FCS champion North Dakota State. Johnson will need to prove he's the same imposing down-hill runner against NFL defenses, but he'll add depth to any backfield. Johnson's highlight reel is impressive.
Javorius Allen, USC
Allen, nicknamed 'Buck,' enjoyed a fantastic junior season for the Trojans with 1,489 rushing yards and 11 TDs against Pac-12 competition. He had eight 100-yard games in USC's first nine contests before a late-season fade of sorts. He still finished with 5.4 yards per carry and 11 TDs, and he also had 41 receptions out of the backfield. Allen built his draft stock by running a 4.53 in the 40-yard dash at the NFL Combine. Allen won't cost much, but he's the type of back who can build some draft-day capital with an impressive preseason.
Jeremy Langford, Michigan State
Langford flourished at Michigan State the past two seasons with back-to-back 1,400 yard seasons. He also averaged 20 rushing TDs in those two seasons as the centerpiece of a pro-style offense. Langford ran a 4.42 in the 40-yard dash at the NFL Combine. He's not quite as flashy as predecessor Le'Veon Bell, and Langford doesn't have the same presence as a pass-catcher. Here's the reason to be impressed with Langford: He rushed for at least 100 yards in 16 of 17 games against Big Ten competition the past two years. He's a proven physical runner who will get a shot at some point.
Amari Cooper, Alabama
Cooper ran an impressive 4.42 in the 40-yard dash at the NFL Combine, but potential fantasy owners should focus even more on these numbers: 124 receptions, 1,727 yards and 16 TDs. Those were Cooper's totals last season at Alabama. Cooper plays bigger than his 6-1, 211-pound frame, so he can work the sidelines and the middle of the field. Depending on where he ends up, he has the potential to be an immediate contributor and work as a WR2 in fantasy leagues.
Kevin White, West Virginia
White has elite speed (4.35 40-yard dash time) and good size (6-2, 215 pounds) and could easily be the top rookie receiver in this year's class. He caught 109 passes for 1,447 yards and 10 TDs last year, but with Tavon Austin's relative struggles so far in the NFL, fantasy owners will be leery of trusting another West Virginia receiver. White and Austin had almost identical 40 times, but the former stands almost seven inches taller and weighs 40 pounds more. Even though White's stats might have been inflated by playing at WVU, he has more physical tools at his disposal than Austin and should be in better position to succeed in the NFL.
Dorial Green-Beckham, Oklahoma
Few receivers can match Green-Beckham's size (6-5, 237 pounds) and speed (4.49 40-yard dash) – not just in this year's draft class, but in the entire NFL. Of course, it's not all good news for the former Missouri standout. DGB was limited to practices at Oklahoma last year after getting dismissed from Mizzou for misconduct (two marijuana violations and an investigation involving a physical altercation with his girlfriend). Green-Beckham had a breakout sophomore season, catching 59 passes for 883 yards and 12 TDs, and got stronger as the season went on. It's always tough to evaluate players who sat out a year, but physically, Green-Beckham is ready to contribute right away. Whether he can put it all together, keep his nose clean, and adapt to an NFL offense is another story, but his size alone makes him a red zone presence from Day 1, which, in turn, makes him worth stashing on fantasy rosters.
DeVante Parker, Louisville
Parker has good size (6-3, 208 lbs) and speed (4.45 40-yard dash time) and proved to be a dynamic big-play guy during his four years at Louisville. He averaged 19.9 yards per catch last year, and over his final three seasons, he scored 27 touchdowns in 32 games. He was limited to just seven games last season after breaking the fifth metatarsal in his left foot, but he'll be fully recovered for the start of next year. As is the case with most rookie receivers, Parker could be inconsistent, but the tools are there for big production.
Jaelen Strong, Arizona State
What's not to like about Strong? He produced big numbers during his two years in college (average of 78.5 catches, 1,143.5 yards, 8.5 TDs), has great size (6-4, 212 pounds) and speed (4.44 40-yard dash time) and can jump out of the gym (42-inch vertical). If Strong winds up in the right situation, he could contribute Week 1 and function as a legit WR3 for fantasy owners.
Devin Smith, Ohio State
Smith averaged a ridiculous 28.2 yards per catch during his final season in Columbus, which allowed him to post 931 yards and 12 TDs despite catching just 33 balls. Obviously, Smith has to become more polished before consistently contributing, but at 6-1, 200 pounds and possessing 4.42 speed, Smith has the tools to be a nice boom-or-bust play.
Breshad Perriman, Central Florida
Perriman ran a 4.25 40-yard dash during his pro day, which is impressive however you look at it, but when you factor in that he's 6-2, 212 pounds, it's downright scary. The Central Florida star put up 1,044 yards and nine TDs on just 50 catches last year and possesses elite game-breaking ability. As a rookie, Perriman will likely to be a boom-or-bust player, but he possesses a good amount of Dynasty value depending on where he ends up.
Nelson Agholor, USC
Agholor steadily improved throughout his three-year career at USC, but he really broke out last season, catching 104 passes for 1,313 yards and 12 TDs. The 6-0, 198-pounder ran an impressive 4.42 40-yard dash at the NFL Combine, so he could sneak up (or past) on some defensive backs if he gets a chance to play.
Sammie Coates, Auburn
Coates has the size (6-2, 212 pounds) and speed (4.43 40-yard dash), but it's reasonable to expect an adjustment period going from Auburn's sped-up, run-heavy attack to an NFL offense. Coates averaged 21.6 yards per catch over the past two seasons, but it seems unlikely he'll have consistent success in Year 1 in the NFL. He's worth watching as the season goes on if you're in a Dynasty League.
Phillip Dorsett, Miami
Dorsett is this year's "undersized speedster du jour" after running a 4.33 40-yard dash at the NFL Combine. The 5-9, 185-pounder really broke out last year, averaging 24.2 yards per catch and scoring 10 touchdowns. He profiles similar to Tavon Austin, only without the high volume of pass-catching reps. Dorsett has upside, but it might take him a while to find a consistent rhythm within an NFL offense.
Rashad Greene, Florida State
Greene lacks ideal size (5-11, 182 pounds) and top-end speed (4.53 40-yard dash), but the back of his hypothetical football card is impressive. Greene posted consecutive 1,100-yard seasons, including a 99-catch, 1,365-yard campaign in 2014. He was never a big touchdown guy in college, but he caught at least seven all four seasons. He finds a way to get it done, and he has the chance to be a real steal for whatever team winds up with him. Dynasty leaguers will want to keep tabs on Greene all season.
Tre McBride, William and Mary
McBride has gotten some buzz thanks to an impressive Combine performance that included a 4.41 40-yard dash time, but his numbers at FCS William and Mary don't jump off the page (64-809-4 last season). His best year was actually in 2012 when he averaged 81.5 yards per game and scored 10 times. There could be a number of reasons for his relative regression, but McBride (6-0, 210 pounds) will need some seasoning before becoming a factor in fantasy leagues.
Tyler Lockett, Kansas State
Lockett caught 106 passes for 1,515 yards and 11 TDs during his final season at Kansas State. At 5-10, 182 pounds, he has "possession receiver" written all over him, and his 4.40 40-yard dash time suggests he could have major success in that role if he finds the right home.
Maxx Williams, Minnesota
Williams' size is impressive, and the 6-4, 249-pound tight end impressed even more with the second-fastest 40 time among tight ends (4.77). Williams led Minnesota in every receiving category with 36 receptions, 569 yards, eight TDs last season. He did that with opposing defenses knowing he was the best option in a light-passing attack. Six of Williams' TDs came in the red zone last season, and he averaged 16.2 yards per catch the last two years. He also scored a highlight-reel 54-yard touchdown in the Citrus Bowl against Missouri. Williams should be a situational player right away, and he'll make some flashy plays.
Devin Funchess, Michigan
Funchess (6-4, 232 pounds) profiles as a slower, lighter version of Detroit's Eric Ebron, which isn't the best sell for fantasy owners. Funchess switched from tight end to receiver as a junior, but he ran a 4.70 in the 40-yard dash. Funchess played through injuries and inconsistent quarterback play the past two seasons, but he has shown the ability to be a presence in the intermediate passing game. He averaged 15.3 yards per catch as a tight end as a sophomore before becoming more of a possession read with 11.8 yards per catch as a junior. There's potential down the line, and Funchess has shown glimpses of tremendous athletic ability. He'll need to land in an offense that showcases his versatility to be a factor as a rookie.
Nick O'Leary, Florida State
O'Leary (6-3, 252 pounds) brings a physical presence to the position, but his stock slipped a bit after he ran a 4.93 in the 40-yard dash at the NFL Combine. O'Leary, however, can work between the seams. He scored five of his 13 TDs outside the red zone over the past two seasons, and he had 11 games with more than 50 yards. He can line up in the slot, which will be an attractive fit for an offense looking for help at tight end. There's some sleeper appeal, but he'll likely be a boom-or-bust play as a rookie.
Clive Walford, Miami
Walford in the next in the long line of tight ends to come from "The U," and he's one of the bigger tight ends in this year's class at 6-4, 251 pounds. Walford enjoyed a breakout season with the Hurricanes as a senior with 44 catches for 676 yards and seven TDs. He closed the regular season strong with back-to-back 100-yard games against Florida State and Virginia. Six of Walford's seven scores came inside the red zone last year. He'll start as a late-round flier and a backup fantasy option, but there's upside here if you trust that Miami pipeline.