text:
[SMH | Text-only index]
Date: October 13 2012
Former Australian police chief Mick Keelty has revealed how golf diplomacy helped crack the Bali bombing case and bring the holiday island's tourist economy back from the dead.
Keelty, Australian Federal Police (AFP) Commissioner at the time of the 2002 terrorist attacks, told how he and then Indonesian police chief Da'i Bachtiar forged a co-operation deal while playing golf at Perth's Joondalup resort a few months before the bombings.
Their conversation, a world away from the staid, formal talks involving interpreters and officials, would take on a special significance after October 12 that year.
"When you're in a golf buggy together you can talk about anything," Keelty told AAP in an interview after attending this week's 10th anniversary memorial service in Bali.
"He was telling me about the secessionist movements in Papua, and about the Free Aceh movement, and there had already been bombings in Jakarta.
"He said, 'We don't have post-blast analysis capability'.
"So I said, 'We'll put something together for you on the back of the deal we have just signed'. So we continued our game of golf.
"When the bomb went off Da'i rang me and said, 'Do you remember the conversation we had in the golf cart?' He said, 'I need those forensic people now'."
Keelty said that when he was first appointed AFP Commissioner, Singapore's Khoo Boon Hui, now President of Interpol, had told him: "'Well, that means you're going to have to learn to play golf. That's the way you do it up here, because the Indonesians love their golf'. And it turns out to be true."
Keelty praised the work of Indonesian police in bringing all of the Bali killers to justice, something he doubted could be done as he stood in the rubble of the Sari Club days after the attacks.
"If I was honest with you I'd have to say I didn't think it could be done," he said.
"I don't think I myself believed we could get on top of it as quickly as we did. And I use the royal 'we'. It's a great credit to them (Indonesian police)."
One great legacy of the successful police investigation, and the fight against terrorism generally, was that it created a secure and politically stable environment in Indonesia.
Indonesia's GDP growth of 6.5 per cent was one of the best in Asia.
"Once you get the security situation right, then you can focus on health, education and infrastructure to help the economy grow," he said.
"There is now an opportunity for business to come here and help develop the country, and do well for Australia, and it's happening."
Keelty said he was pleased to see a vibrant Bali again after the terrorist attacks knocked its economy for six.
"It was dead. The hotels were empty, the businesses had shut down, the flights had stopped. It was like a ghost town. Now the place is alive again."
The successful Bali operation led Indonesia and Australia to establish the Centre For Law Enforcement Cooperation in Jakarta, which focused on trans-national crime, particularly terrorism.
"That's a very positive bricks and mortar legacy," said Keelty.
"There's been 11,000 students go through that.
"The other legacy is that the people who came after us, including (current AFP commissioner) Tony Negus, have continued the (Australian-Indonesian) partnership."
Australia's initial co-operation with Indonesia on the Bali bombings was also aided greatly by Keelty's personal friendship with Made Pastika, then Bali police chief and now the island's governor.
The two had studied together in the 1990s, and were talking within minutes of the Kuta bombings.
Both Pastika and Bachtiar have since received Order of Australia (OA) decorations.
This material is subject to copyright and any unauthorised use, copying or mirroring is prohibited.
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subset: commoncrawl


text:
I know a lot of people who turn to Oswald Chambers for their devotional material. They read My Utmost for His Highest every day. I've read that devotional a number of times myself, but for the past couple of years I've been using a book that Ms. Hazel Howell of Canton, Ms. sent to me. [Read More…]
Gimme a God with a Posse
Years ago I read a magazine interview with Brad Pitt. Pitt was raised up in a Baptist household. In the article, which I still have buried somewhere, Pitt said he left behind the faith of his childhood because he thought it was a big cop-out when people use faith as an excuse for not being [Read More…]
The Art of Fame & the Decay of the Superstar
Isn't that the age we live in — that we want to see people who have it all, lose it all? That's the question Lady Gaga posed to Anderson Cooper in her 12 minutes of 60 minutes fame. It's a worthy question, if you accept the premise that the Lady has it all. Gaga is, by [Read More…]


text:
July 2001
Statement to Advisory Committee for Pharmaceutical Science
and OINDP Subcommittee
On the Work of the ITFG/IPAC-RS Collaboration
Regarding Chemistry, Manufacturing, and Controls and
In Vitro and In Vivo Bioavailability/Bioequivalence Issues in
Draft Guidance Documents for Orally Inhaled and Nasal Drug Products
Submitted by:
Inhalation Technology Focus Group of the AAPS
International Pharmaceutical Aerosol Consortium on Regulation and Science
10 July 2001
Table of Contents
Executive Summary4
Summary of Recommendations5
Review of ITFG/IPAC-RS Work and Proposals7
I. In Vitro and In Vivo Tests for Bioequivalence Studies 7
II. Dose Content Uniformity Specifications 12
III. Particle Size Distribution Tests and Specifications 14
A. PSD CMC Specifications 14
B. PSD as In Vitro Test for Bioequivalence Studies 15
IV. Leachables and Extractables Testing 17
V. Supplier Quality Control 19
VI. Tests and Methods for Control of Product Quality 20
This statement is submitted to the OINDP Subcommittee and the Advisory Committee for Pharmaceutical Science in connection with their meetings on 17 and 19 July 2001, respectively.
The agenda for these meetings includes a consideration of the issue of dose-response of locally acting nasal drug products, with particular application to bioequivalence studies. The ITFG/IPAC-RS Bioequivalence and Bioavailability Technical Team offers their views on this topic in section I.2.a (page 7) of this report. Specifically, the Team reviews its findings on this issue, submitted to the Agency in August 2000, and presents its positions developed since the August submission.
We also provide an update on the work of the other Technical Teams of the ITFG/IPAC-RS Collaboration to inform the committee members of the progress made since the last meetings of these committees in 2000, to outline the full scope of our concerns with the draft Guidances for OINDP, and to highlight areas where additional research has been undertaken or proposed by the industry.
Executive Summary
Summary of Recommendations
As demonstrated in the following sections, the ITFG/IPAC-RS Collaboration has investigated a number of open CMC and BA/BE issues in the draft Guidances and looks forward to a careful discussion of its findings by the Agency and other appropriate bodies, such as PQRI, the OINDP Subcommittee, and the Advisory Committee for Pharmaceutical Science. The Collaboration is grateful for the Agency's consideration of its work and proposals. We summarize our general positions below.
Regarding the BA/BE draft Guidance:
Regarding the CMC draft Guidances:
We believe that through additional work in the identified areas, the draft Guidances for OINDP could be significantly improved, which would offer a win/win/win solution for the Agency, industry and patients.
Review of ITFG/IPAC-RS Work and Proposals
At the 26 April 2000 meeting of the OINDP Subcommittee, the ITFG/IPAC-RS Collaboration presented its concerns regarding a number of CMC and BA/BE issues in the FDA draft Guidances and made a commitment to collect and analyze relevant data in order to contribute constructively to the revision of the draft Guidances. A comprehensive review of the ITFG/IPAC-RS work carried out through November 2000 was presented to the Advisory Committee for Pharmaceutical Science on 15 November 2000. Following is a brief update on the work and progress of the Collaboration since these meetings. Copies of the scientific reports prepared by the ITFG/IPAC-RS Collaboration are posted athttp://www.ipacrs.com/submissions.html, and are also available through the FDA dockets for the draft Guidances.
The BA/BE Technical Team of the ITFG/IPAC-RS Collaboration reviewed the draft Guidance for Industry: Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action, reviewed and analyzed available literature and data, and has prepared and submitted to the FDA three technical papers. The papers outline the key concerns with the draft BA/BE Guidance and propose possible approaches for the way forward.
2. BA/BE Work to Date
2.a. Dose-Response and Transfer of Indications for Locally Acting Nasal Drug Products
In the paper entitled Technical Paper on FDA's Bioavailability and Bioequivalence Questions Presented at 26 April 2000 OINDP Advisory Subcommittee Meeting, submitted to the Agency in August 2000, the Team addressed the Agency's questions regarding clinical studies for locally acting nasal drugs. Based on the review of published data, the Team arrived at the following conclusions:
Since the last Advisory Committee meeting, the BA/BE Team has sought additional information to answer the questions posed in connection with dose response studies, in vivo study waivers for locally acting nasal products, and test metrics for in vitro as well as in vivo comparisons. This effort continues to reinforce the earlier findings that the development of robust clinical protocols, the availability of reliable metrics, and the establishment of relevant in vitro test platforms are lagging behind present regulatory needs.
Because of this lack of firm information upon which to base sound regulatory policies, the BA/BE Team has analyzed the problem from the standpoint of risk management. The idea is to focus thinking and scientific investigation toward those critical elements whose uncertainty should be given priority as the development of guidances progresses. This analysis has brought forward three risk areas that are present with locally acting nasal sprays in the context of dose response and clinical equivalence:
While the first two risk areas can possibly be grouped together and dealt with in a single trial, the third must be treated independently. In fact, the types of clinical trials needed to address each risk area may be very different in nature and construction. It cannot, therefore, be presumed that an in vitro test that correctly correlates with the local actions will also be predictive of the systemic outcome.
Although the Team agrees that development and validation of an appropriate model for assessing dose-response as a model of in vivo equivalence (in terms of local efficacy and local side effects) is an important element in development of equivalence standards for this group of products, the BA/BE Team believes that the highest risk area in the establishment of product equivalence is the systemic absorption component. We suggest that the design of studies to assess systemic availability and equivalence between nasal solutions for local action deserves the highest level of attention.
2.b. Role of In Vivo and Vitro Tests for Bioequivalence Studies
In the paper entitled Review of In Vivo and In Vitro Tests in FDA's Draft Guidance on Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action and Anticipated Forthcoming Guidance for Orally Inhaled Drugs, the Team described and supported its two general position statements that (i) in vitro testing is essential for pharmaceutical product equivalence and should be included as part of the BA/BE Guidance for all nasal and oral inhalation products, but is not currently sufficient for BE approval without establishing in vivo BE; and (ii) for BE approval, BA/BE Guidance documents for nasal and oral inhalation drug products for local action should require use of validated human models for in vivo testing for local and systemic exposure, efficacy and safety.
One of the Team's hypotheses expressed in that paper is that:
the assumption that in vitro studies alone are sufficient for BE of solutions is unfounded. The draft BA/BE Guidance should not distinguish between nasal suspensions and solutions for in vivo BE.
Following the submission of the paper, the Agency requested that this position be substantiated with additional data. In response to this request, the Team conducted further research to supplement its previous survey of the scientific literature in regard to this position. This investigation is described in the Team's third paper, On the Risks of Eliminating In Vivo Studies for Nasal Solutions for Local Action, which was submitted to the Agency in April 2001.
The scope of the survey was expanded to include opinions of international regulators and examples from orally inhaled systems, since many of the underlying concepts, design requirements and performance attributes of drug/device combinations for orally inhaled products parallel closely those demanded of nasal solutions and nasal suspensions. Unfortunately, even after this thorough evaluation of the available literature and information, the Team was unable to identify references that could provide an unequivocal foundation for either the Team's or the Agency's positions in regard to the bioequivalence of nasal solutions.
The Team has found, however, that there is a lack of documentation from well-controlled, replicate trials that demonstrate (i) the correspondence between the proposed in vitro tests and in vivo measures of safety and efficacy; (ii) the discriminatory capability and reliability of the proposed in vitro tests as surrogate markers for clinical safety and efficacy parameters; and (iii) that the in vitro tests uniformly apply to all classes of drugs under review, i.e., nasal solutions and suspensions for administration via spray or aerosol for local action.
Furthermore, there is clear evidence of a lack of agreement among regulators, as reflected in the current draft CPMP guidance on bioavailability and bioequivalence. This EU guidance proposal does not differentiate between nasal solutions and nasal suspensions for local use (section 5.1.8 (a) of CPMP/EWP/QWP/1401/98). Moreover, it requires pharmacodynamic or comparative clinical studies for locally acting nasal products. Additionally, there is general acknowledgement among scientific and clinical experts regarding the need for more work before the in vitro-in vivo correlations necessary to support waivers of clinical testing for this group of drug/device products can be made.
Because there is not sufficient data to show that in vitro testing methodologies are an adequate substitute for in vivo studies, the Team believes that the Agency should reconsider the draft Guidance's biowaiver provision for nasal solutions for local delivery. In addition, more specific and relevant data must be generated in order to ensure that the final guidance reflects best practices in regulatory science.
2.c. Development of Risk Management Framework
The BA/BE Team believes that the current lack of definitive information and expert consensus regarding the validity of current in vitro testing as a guarantee of in vivo outcome is a risk situation, with unknown clinical efficacy or safety consequences, to the users of nasal pharmaceutical products. However, the current draft Guidance does not acknowledge this risk, and does not, therefore, fall within the risk management framework elaborated in the 1999 Report from the Task Force on Risk Management to the Commissioner.
The Team has outlined three possible risk management approaches (i.e., risk avoidance, risk stratification, and risk comparison) that may be incorporated into the Guidance until relevant data on the sufficiency (or insufficiency) of in vitro testing to demonstrate bioequivalence of nasal solutions is generated.
The Team is a committed stakeholder in this process and is interested in exploring with the Agency the manner in which the appropriate risk analysis and risk assessment can be brought into the text of the draft Guidance. The Team is interested in collaborating with the Agency to define appropriate measurement systems and reliable test conditions which could be adopted to address the risk factors objectively.
Furthermore, correct methods of numerical analysis and valid comparison metrics should be developed, which will ensure that a uniform state of minimized risk is maintained. In the meantime, the Team strongly recommends that any consumer risk should be avoided by requiring that all nasal solution, as well as suspension, products meet both the in vitro and in vivo BE criteria suggested in the draft Guidance.
3. Team's Current Activities
In light of the current lack of data regarding appropriate in vitro tests to establish equivalence of nasal solutions, the Team will propose to explore the following hypothesis through PQRI:
sole reliance on the in vitro tests outlined in the draft BA/BE Guidance may not be sufficient to establish bioequivalence, including equivalent systemic absorption (for safety purposes) between two Q1/Q2-equivalent nasal solution products which exert their efficacy through local action.
In parallel, the BA/BE Team will also develop a risk management framework for addressing risks of elimination of in vivo studies for nasal solutions.
4. Next Steps Regarding In Vitro and In Vivo Tests in draft BA/BE Guidance
The Team is grateful that the Agency has recognized the value of gathering and evaluating relevant data through PQRI and addressing the risks inherent in FDA's biowaiver provision for nasal solutions for local delivery.
1. Overview of Key Concerns with DCU Specifications in FDA Draft Guidances
At the 26 April 2000 meeting of the OINDP Subcommittee, the DCU Working Group committed to examine the suitability of the DCU specifications recommended by the FDA Guidances and to explore alternate approaches to setting DCU specifications that would ensure consistent and uniform dosing for each drug product. As a first step in these investigations, the Working Group committed to collect industry data and to evaluate the following hypothesis:
The current state of OINDP technology may not allow general compliance with the dose content uniformity specifications in the draft FDA CMC Guidances.
FDA has also acknowledged that the current approach to DCU specifications in the draft CMC Guidances may need to be re-evaluated. At the April meeting, the Agency posed the following questions6:
Should there be a single content uniformity standard for all orally inhaled and nasal drug products? Should the FDA continue development of the proposed statistical approach to evaluating content uniformity?
2. DCU Work to Date
In the spring of 2000, the DCU Working Group conducted an industry-wide survey of DCU data. The initial analysis of the collected data was presented in a technical paper submitted to the Agency and the members of the OINDP Subcommittee on 31 July 2000. In the paper, the Working Group concluded that the database indicates that orally inhaled products do not in general comply with the DCU specification in the FDA's draft Guidances and that the relatively large differences between products and between product types suggest that a single content uniformity specification for all inhaled and intranasal drug products is not suitable. These findings were reported at the November 2000 meeting of the Advisory Committee for Pharmaceutical Science4.
Since the fall of 2000, the DCU Working Group has been exploring alternate approaches to DCU specifications and has developed a new DCU test, which is grounded in general statistical considerations, quality standards set by the draft Guidances, and the capabilities of modern inhalation technology. The new test follows the parametric tolerance interval approach propounded by Dr. Walter Hauck. The test also builds upon certain aspects of the approach put forth by the Pharmacopeial Discussion Group of ICH. The main features of the test developed by the Working Group can be summarized as follows:
3. Current Activities
The IPAC-RS companies and the DCU Working Group under the leadership of prominent industry experts have undertaken an unprecedented effort to develop a test that could replace the DCU tests in the draft CMC Guidances. In this process, the DCU Working Group has consulted with ITFG scientists, academicians and representatives of the Agency.
The Working Group expects to submit a written proposal on the alternative DCU test to the Agency in the fall of 2001. The Working Group believes that the proposed test will benefit the Agency, the industry and patients by establishing a long-term solution to the control of DCU in OINDP, by ensuring consistent quality standards for such products, and by facilitating the development and CMC approval of new orally inhaled and nasal medicines.
4. Next Steps Regarding DCU Specifications
We acknowledge and appreciate the Agency's attention to the critical issue of DCU. We encourage members of the OINDP Subcommittee and Advisory Committee for Pharmaceutical Science to consider our forthcoming DCU proposal for an alternative approach to DCU testing. To facilitate the evaluation of the new test by the Agency and other relevant parties, we encourage a broad scientific discussion of the merits of the proposed test. In this spirit, the IPAC-RS proposes to hold, in coordination with all interested parties, a public workshop on the newly developed test, once the written proposal of the DCU Working Group is submitted to the FDA docket.
A. PSD CMC Specifications
1. Overview of Key Concerns with PSD in FDA Draft CMC Guidances
The PSD Working Group's key concerns regarding the current draft CMC Guidances for OINDP are related to the requirement that:
the total mass of drug collected on all stages and accessories is recommended to be between 85 and 115 percent of label claim on a per actuation basis.
The PSD Working Group strongly objects to the inclusion of the mass balance specification in the CMC Guidances because:
2. Work to Date on PSD issues in CMC Draft Guidances
At the 26 April 2000 meeting of the Subcommittee, the PSD Working Group committed to collect industry PSD data to investigate the suitability of the mass balance requirement. In a paper that was subsequently submitted to the FDA and the members of the OINDP Subcommittee, the Working Group concluded that:
the initial assessment of the database indicates that orally inhaled products do not in general comply with the proposed mass balance requirement in the draft CMC Guidances (85-115% LC) and that the proposed requirement is not suitable as a drug product specification but could be appropriate as a system suitability test defined on a case by case basis.
The Working Group also used the collected database to carry out an initial investigation of the utility of the requirement in the draft CMC Guidances that 3 to 4 stage groupings be used for PSD specification.
3. Current Activities
The PSD Working Group would like to receive clarification from the Agency on the intention of the mass balance requirement and to explore alternate ways to address the Agency's concerns. The Working Group has prepared a proposal for PQRI to investigate this issue and to make a data-based recommendation for the CMC Guidances.
4. Next Steps Regarding PSD CMC Specifications
We respectfully request that the OINDP Subcommittee and the Advisory Committee consider the PSD Working Group's previous submission10 in support of the recommendation that the mass balance specification requirement be removed from the CMC Guidances. If appropriate, additional dialogue on PSD specifications and the utility of mass balance should take place, possibly through PQRI.
B. PSD as In Vitro Test for Bioequivalence Studies
1. Key Concerns with PSD in Draft BA/BE Guidance
The draft BA/BE Guidance recommends that in order to establish bioequivalence, the Test and Reference products have to demonstrate equivalent PSD profiles. The method for profile comparisons recommended by the draft BA/BE Guidance is based on chi-square differences. However, this method has a number of limitations, as reflected in the Agency's question to the OINDP Subcommittee in April 2000 regarding the appropriateness of the chi-square comparative approach.6
Some of the limitations of the chi-square method are the following:
2. Work to Date on PSD Issues in BA/BE Draft Guidance
Using industry data, the PSD Working Group carried out an initial investigation of alternate analytical techniques, such as that based on bootstrapping, that may improve the discriminating ability of profile comparisons, and provide consistency in the approach used for various products and measuring devices. The Working Group also believes that methods using different metrics, or weighting factors, should be investigated, as they may better reflect the clinical relevance of different portions of the particle size profile when making a decision regarding bioequivalence of two products.
3. Current Activities
The PSD Working Group prepared a proposal for investigating through PQRI the following hypothesis:
A method for comparing particle size distributions of the Test and Reference product may be developed such that it does not depend on particular product type or particle sizing equipment, and may include metrics that relate to clinical relevance of various particle sizes.
4. Next Steps Regarding PSD BE Issues
The PSD Working Group recommends that further investigation of the profile comparison methods be undertaken in order to identify appropriate means to compare Reference and Test products and to evaluate what test metrics have clinical relevance.
1. Overview of Key Concerns with Leachables and Extractables in CMC Draft Guidance
At the April 2000 OINDP Subcommittee meeting and at the November 2000 meeting of the Advisory Committee for Pharmaceutical Science, the Leachables and Extractables Team committed to preparing a data-based technical report and recommendations on leachables and extractables. In March 2001, the Team submitted its paper entitled Leachables and Extractables Testing: Points to Consider to the Agency and the members of the OINDP Subcommittee and the Advisory Committee for Pharmaceutical Science. In this technical paper, the Team identified several areas of the draft CMC Guidances regarding leachables and extractables that could benefit from clarification or further development, and made recommendations regarding these areas.
2. Leachables and Extractables Team Work to Date
To address key areas of concern in the draft CMC Guidances, the Team conducted industry-wide surveys of current practices utilized by pharmaceutical companies as well as suppliers of components for finished drug products. The Team also collected leachables and extractables data and conducted literature reviews, where appropriate. In its work, the Team drew on the collected data and the expertise of leading analytical chemists, product development scientists and toxicologists. The recommendations contained in the Points to Consider paper are based upon relevant data and best industry practices. In particular, the Team recommended that the CMC Guidances should:
3. Current Activities
The Team will submit to PQRI a proposal to investigate the Team's recommendations, and in particular the development of reporting and qualification thresholds for leachables.
4. Next Steps Regarding Leachables and Extractables
The Leachables and Extractables Team recommends that the Guidances for OINDP incorporate a leachables qualification program, including reporting and toxicological qualification thresholds for leachables. Further, the Team strongly recommends that the approach to establishing reporting and qualification thresholds, and the thresholds proposed by the ITFG/IPAC-RS Collaboration be evaluated and carefully considered by toxicologists and chemists from the FDA, industry, and academia. The Team looks forward to such considerations through the PQRI process.
1. Overview of Key Concerns with Supplier Quality Control in CMC Draft Guidance
The current draft CMC Guidance documents in several instances require excessive testing of the finished product in an attempt to control changes in the supply chain. The Supplier Quality Control Team of the ITFG/IPAC-RS Collaboration believes that the appropriate way to control quality of incoming components is through a comprehensive system of supplier quality control.
2. Work to Date on Supplier Quality Control
As reported at the April 2000 meeting of the OINDP Subcommittee and the November 2000 Advisory Committee meeting, the Supplier Quality Control Team, which includes representatives of pharmaceutical as well as supplier companies, conducted a survey of current cGMP practices among the suppliers of pharmaceutical device components. The survey identified existing practices that could be used as a standard for the supplier industry and areas that would benefit from the development of comprehensive cGMP guidelines.
3. Current Activities
The Team is exploring the feasibility of an industry-wide initiative to undertake the development of a cGMP guideline for suppliers of pharmaceutical device components.
4. Next Steps Regarding Supplier Quality Control
The Team encourages the OINDP Subcommittee and the Advisory Committee for Pharmaceutical Science to recommend that the Agency consider inserting into the revised CMC Guidance documents a statement that recognizes the value of a cGMP guideline for component suppliers, and acknowledges that if sufficient supplier control mechanisms are in place, appropriate reductions in testing will be considered.
1. Overview of Key Concerns with Tests and Methods in CMC Draft Guidance
The draft CMC Guidances require a large number of tests on the finished drug product, some of which are redundant or add little value to the assurance of product quality. The Tests and Methods Technical Team of the ITFG/IPAC-RS Collaboration outlined its concerns at the April 2000 OINDP Subcommittee meeting and the November 2000 meeting of the Advisory Committee for Pharmaceutical Science.3,4
2. Tests and Methods Team Work To Date
In 2000, the Team committed to collect industry data on key tests recommended by the draft CMC Guidances and to prepare and submit a technical report to the FDA containing the Team's findings and recommendations. In May 2001, the Team completed its work on the MDI tests of greatest concern to the Team and submitted a paper entitled Recommendations for Tests and Methods to the Agency. The paper focused on the following tests: water content, shot weight, plume geometry, pressure, spray pattern, particle size distribution, dose content uniformity, and impurities and degradants. The paper provided a critical assessment of the value that these individual tests add to the development and control of a new product.
In general, the Team recommended that a fixed list of control tests may not be appropriate for all products. Furthermore, the Team proposed that the draft CMC MDI/DPI Guidance:
Through scientific evaluation of industry and literature data, the Team made specific assessments regarding the relative value and usefulness of the investigated tests. For example:
The Team is therefore assessing tests in such a way that they are able to offer recommendations on how to select tests needed to characterize a new product and to control a finished manufactured product. The overall goal is to maximize the value of characterization and control testing, and minimize redundant testing and testing that does not provide meaningful information about product quality.
3. Current Activities
The Team is considering development of proposals that could be submitted to PQRI based on the concepts and the findings in Recommendations for Tests and Methods.
4. Next Steps Regarding Tests and Methods
The Team encourages the Agency, the OINDP Subcommittee and the Advisory Committee for Pharmaceutical Science to consider the conclusions in Recommendations for Tests and Methods. This paper confirms the Team's belief that the revised CMC Guidance should reflect the concept that appropriate control tests for the commercial product should be selected based on the product development data. The Team is hopeful that its findings will assist the Agency in eliminating redundant or unnecessary testing recommendations in the draft CMC Guidance documents.
IPAC-RS and ITFG strongly support the Agency's development of draft Guidance documents for orally inhaled and intranasal drug products. We recognize the value of Guidance documents in facilitating the development and approval of new products. We are encouraged by the Agency's effort to address open CMC and BA/BE issues in developing the Guidances for nasal and orally inhaled medications.
We agree that development and validation of an appropriate dose-response model of in vivo equivalence (in terms of local efficacy and local side effects) is an important element in development of equivalence standards for this group of products but note that in order to manage the potential risk for systemic side effects, there is also a need to establish clear protocols for assessing equivalence of systemic absorption. We commend the Agency on ensuring that pertinent data are evaluated to address the potential risks associated with selecting particular in vitro and in vivo models to demonstrate the bioequivalence of nasal solutions and suspensions for local nasal therapy.
We hope that the Agency continues to work toward resolving all of these important CMC and BA/BE regulatory science issues by utilizing existing avenues for interactive, scientific dialogues, including, as appropriate, the OINDP Subcommittee, the Advisory Committee for Pharmaceutical Science, PQRI, an FDA/USP/AAPS workshop on OINDP regulatory issues, or meetings with representatives of the ITFG and IPAC-RS. Further discussion will ensure that the OINDP Guidances bring maximum value to regulators and industry, and most of all, to patients and physicians.
We appreciate the opportunity to submit this statement to the Agency and the members of the OINDP Subcommittee and the Advisory Committee for Pharmaceutical Science. We hope that this statement and our past and future submissions and interactions will assist the Agency, the Advisory Committee for Pharmaceutical Science and the OINDP Subcommittee in their work on these important documents based on all currently available scientific evidence.


text: Walgreen Withdraws Bid for Longs Drug Stores Walgreen ( WAG) has decided to drop its pursuit of Longs Drug Stores ( LDG), citing the broad financial meltdown. Walgreen had offered $75 per share in cash -- which was higher than the CVS Caremark ( CVS) offer of $71.50 per share in cash. The board for Long's Drug Stores refused to discuss any agreement with Walgreen's management. We think Walgreen is making the best move it can at this time. The credit markets are tough -- so financing for any deal may have come at a prohibitive cost. We advised investors to take profits on the run-up in LDG shares back in mid-September, when shares jumped up to $76 right after the WAG offer. That call looks even better now -- after Walgreen's subsequent withdraw. None of the stocks mentioned above are on our "Recommended" list. MetLife/Hartford Financial Services Reportedly Mulling Merger It appears that MetLife ( MET) and Hartford Financial Services ( HIG) may be considering a potential merger, according to a Wall Street Journal report. According to the WSJ, MetLife recently approached Hartford regarding a merger -- but the talks "didn't lead anywhere." Both companies have seen their stock prices hit hard over the last month and have taken steps to increase their liquidity. Hartford Financial recently got a $2.5 billion capital infusion from Allianz SE -- Europe's biggest insurer -- while MetLife raised nearly $2 billion after an offering of 75 million shares at $26.50 per share. MetLife also announced a plan to cut jobs -- but didn't offer details about that plan. We prefer either company look for a stronger partner, rather than the thought of putting two struggling companies under one roof. Basic arithmetic states that when you multiply two negative numbers, you get a positive, but we're not sure that rule applies on Wall Street.


text:
When fresh tomatoes are in season, this is a lovely snack or appetizer. Spooned on to crostini the flavour bursts with freshness. It takes only a few minutes to assemble so it's good for when the neighbours drop by.
- 2 medium tomatoes, seeded and chopped
- 2 tbsp chopped red pepper
- 2 tbsp chopped green pepper
- 1 tbsp finely chopped red onion
- 1 tbsp. good balsamic vinegar
- 2 tbsp. olive oil
- 4 or 5 large basil leaves coarsely chopped
- salt and pepper to taste
- a few drops hot pepper sauce if desired
For the Crostini
- 1 baguette
- 1 tbsp olive oil
- 1-2 cloves garlic minced
- Combine all bruschetta ingredients in a bowl and let stand while you prepare the crostini.
- Combine olive oil and minced garlic in a small bowl.
- Slice Baguette and toast slices under the broiler until lightly browned.
- Lightly brush baguette slices with garlic olive oil and place in serving basket.
- Pass the bruschetta and spoon a generous amount on the crostini.


text:
Sit up and take note!
Date published: 21 January 2014
MAHDLO has smashed a wacky world record - for the most people doing simultaneous sit-ups.
A total of 369 participants packed into the Egerton Street youth zone's sports hall with schools, Mahdlo patrons and even Latics mascot Chaddy the Owl taking part.
Oldham Mayor, Councillor John Hudson, and Chf Supt Catherine Hankinson, were also on hand to count each participant as they took up position on the floor.
Everyone involved had to complete full sit-ups continuously for a minute to beat the record and claim a spot in the history books.
The attempt, which will be officially verified at a later date, was also an inventive way to mark a new partnership with leading education provider Commando Joes, which will be visiting schools around Oldham and promoting the youth zone.
Schools taking part in the challenge were Heys Primary, St Anne's Royton, Alexandra Park, Holy Cross, Stoneleigh, St Joseph's and Fir Bank.
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Zhongwei Food
Last updated by chinatravel at 2017/5/15
The food in Zhongwei is mainly made from flour, such as Yanmianrourou (A Kind of naked oats Made Snack) and other dishes. The famous Steamed Northern bronze gudgeon is one of the unique and delicious specialties that can not be missed. Zhongwei is also famous for its dairy products and mutton. Crispy and tasty Mihuangzi (a kind of pancake made of rice flour) and fried pig livers are also very famous all over China. Moreover, there are many other authentic and delicious dishes, such as Fried Tofu with Vegetable, Sautéed Camel Hoof, Braised Beef in Brown Sauce, Hand pulled Saozi Noodles, Muslim cuisine and so on.
Zhongwei Featured Food:
Hand Pulled Saozi Noodles (hand Pulled Noodle With Minced Meat)
With a long history, Hand pulled Saozi Noodles is a traditional characteristic wheaten food in northwest China. It is famous for its five features: thin, chewy, hot, sour and fragrant. Noodles here are thin and long, Saozi is made of fresh pork, and the soup here includes many ingredients: black funguses, Tofu, egg, Daylily, garlic sprouts and carrots. Hand pulled Saozi Noodles plays an important role in people's daily life in the northwest region, such as weddings, funerals, birthday ceremonies and festivals.
Braised Beef In Brown Sauce
As a kind of famous Muslin dish, Braised Beef in Brown Sauce is loved by people of all ethnic groups in Zhongwei. The basic way of making it is easy. Firstly, cut the fresh beef into pieces and parboil it. Then, put the ingredients into the pot, such as ginger, scallion, and bean butter with chili oil, soy sauce, pepper, white spirit, MSG and star anise and so on. Braise them until the flavor is fully absorbed by the beef. It tastes extremely delicious and is good for improving the immunity of human beings.
Steamed Northern Bronze Gudgeon (gezi Fish)
Steamed Northern bronze gudgeon is also called Gezi Fish, a kind of pigeon-looking fish. This kind of fish lives in the embayment from Zhongwei to Shiju Mountain. It is a kind of precious fish in Ningxia Province with soft and fresh taste. The method of making Steamed Northerm bronze gudgeon is easy. Firstly, kill a Gezi fish and cut some stripes on it. Then put it in pickle with salt, pepper, MSG, white spirit, scallion and ginger for one hour. The last step is steaming. When it is ready, the spicy taste will absolutely stimulate your appetite.
Yanmianrourou (a Kind Of Naked Oats Made Snack)
Stemming from Guyuan City, Yanmianrourou is a folk style savory food. Right now, this food can be found all over Ningxia Hui Autonomous Region. The materials for this snack include naked oats, cooked Chinese chives, cooked spinach, garlic sprouts, salt, chili, garlic, vinegar and vegetable oil. The process of making the snack is difficult, yet the essence of the procedure is to make good naked oats noodles, which can be tasted delicious and chewy.
Fried Tofu With Vegetable
As one of the most well-known snacks in Zhongwei, Fried Tofu with Vegetable is a dish that is cooked with fresh materials through traditional recipes. Firstly, fry the fresh Tofu in sesame oil until the Tofu is yellow just like gluten. Then spinach, carrot in slices and chili oil are added in. It looks appetitive for its red, yellow and green materials. At the same time, it tastes delicious and chewy. Moreover, it is a kind of popular vegetarian food appropriating for all ages.


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There's such beautiful fruit in season in Italy right now – plums, peaches, apricots, melons, cherries – all my favourites. As much as I love eating unadulterated fruit, I love cooking with it. Perfectly ripe, sweet fruit needs little embellishment to make a fab dessert. Italians make the most delicious pastries and puddings with fruit. One of my favourite Italian sweets is fruit crostata (tart). This peach crostata is so easy and simple and makes the most of sweet peaches. You could also use other stone fruit in season – I reckon apricots and plums would work well too.
This recipe is taken from My Amalfi Coast.
- 250 g strong plain flour (I used Italian 'OO')
- 125 g sugar
- 125 g butter at room temperature, chopped
- 1 egg and 1 egg yolk
- 500 g fresh peaches, sliced (this is about 5 big peaches)
Tip the flour onto a clean board and mix with the sugar. Rub in the butter with your fingers to combine. Make a well in the centre and add the egg and egg yolk. Mix with your fingers to break the yolks and then lightly knead the ingredients together, making sure not to overwork the pastry. Roll into a ball, wrap in clingfilm and leave in the fridge for a couple of hours.
Heat the oven to 180 C. Roll out the pastry into a rectangle in a baking tray. Arrange the peach slices on top and sprinkle with a bit of sugar. Bake for about 35 minutes, or until the crust is golden.


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Atlantis star Jack Donnelly stabbed himself on set
Jack Donnelly and Roberts Emms from the television programme Atlantis joined BBC Breakfast to talk about the show.
Jack, 28, who does his own stunts, was seriously injured after taking the wrong knife on to the set.
He said: "I meant to grab a rubber knife but I picked up a real one that was meant to be used for a close-up and I stabbed myself through the elbow".
The actors Jack Donnelly and Robert Emms, who play Jason and Pythagoras explained what happens when stunts go wrong.
06 Nov 2013
- From the section Entertainment & Arts


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The City of Sydney, the Property Industry Foundation and the Salvation Army have transformed a former inner-city medical centre into long-stay accommodation for up to seven young homeless.
Lord Mayor
She said there was "an urgent need for more quality, affordable housing close to the city" to ensure the young could live close to support networks and employment opportunities and be part of "a diverse, caring and fair city".
The City of Sydney contributed the property and $250,000 for essential compliance works; the Property Industry Foundation spent $250,000 on renovation and refurbishment: and the Salvation Army will provide 24-hour support through two house "parents" from the Oasis Youth Support Network.
PIF chief executive Rosemary Smithson said the foundation had placed 12 young people in jobs in property as part of its Rebuild a Young Life program, but found that good accommodation was essential for solid employment.
"PIF House will cater for up to 40 young people over the next five years," Ms Smithson said.
Mainbrace and Thiess volunteered builders while Suters gave architecture and design services. Businesses including Apollo Kitchens, Feltex Carpets, Fisher & Paykel, GWA Bathrooms & Kitchens and Peter Kelly Flooring donated supplies.
They have rebuilt the property to have seven bedrooms, two communal bathrooms, four living areas, a courtyard and the house parents' quarters.
Ms Moore said PIF House was testament to the "great work that can be achieved when councils, charities and the corporate sector work together to address real need with genuine, long-term solutions".
PIF raises more than $1.5 million a year to address youth homelessness.
The Australian Financial Review


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Neat little write up on lan gaming using M0n0wall:
Slashdot has it here:
Chet Harvey
Pitbull Technologies <http://www.pittech.com/>
Protecting your Digital Assets
Quoting Chris Buechler <cbuechler at gmail dot com>:
> On 8/8/05, Charlie Barker <CharlieBarker at redlinesoftware dot co dot uk> wrote:
> > Hi all,
> >
> > We had a m0n0wall working as a firewall / gateway (running on a soekris
> Net
> > 4501) for our servers all working fine for a couple of months until we
> > tried connecting the WAN port of the m0n0wall via a switch rather than
> > directly to the Cat5 cable supplied at our colo facility. After we tried
> > this we could no longer ping any internet addresses. We put everything
> back
> > as it was but we still couldn't ping the outside world!
> >
> Still getting a link light? Given what you've tried already, I'd ask
> the colo what they're seeing on with their switch, as I'm sure they're
> using managed switches and could probably tell you at least something.
> (if they're not using managed switches, *run* out of there with your
> boxes and find a real colo)
> -Chris
> ---------------------------------------------------------------------
> To unsubscribe, e-mail: m0n0wall dash unsubscribe at lists dot m0n0 dot ch
> For additional commands, e-mail: m0n0wall dash help at lists dot m0n0 dot ch


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Jess C. Bedore III is a certified criminal defense specialist, who has been practicing criminal law for over 30 years in Placer County. With experience as a former prosecutor and as one of the few attorneys with certification as a Criminal Specialist by the California State Bar, he has the high level of expertise necessary to fully advise and defend you throughout your case.
Don't Settle For Less - Defend Your Rights
When fighting criminal charges, it's important to find a defense team that knows your rights, and has experience with the intricacies of the law in your state. The attorneys at the Law Offices of Jess C. Bedore III have a combined 50 years of experience practicing criminal law and work hard to provide the defense necessary to reach the most favorable outcomes possible for clients.
DUI Lawyer
Due to recent law enforcement efforts across the country to crack down on driving under the influence, a DUI conviction can carry some harsh penalties. Consequences can involve a suspended license, fines, community service, having an interlock device installed in your car's ignition, and possibly even prison time. Our attorneys defend our DUI clients at their Department of Motor Vehicles hearing, examining and challenging the evidence and ensuring that the officer involved in a traffic stop had probable cause. If you have multiple DUI charges, we will look to get prior charges stricken from the record, which can affect sentencing in a present case.
Easy Consultations for Your Convenience
Our Roseville, California firm is available for calls 24/7, toll-free at 888-319-0305. We're located just 15 minutes from the Santucci Justice Center, and we can visit you in jail and help you post bond if necessary. We offer payment plans and accept credit cards, so call us today for a consultation!


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Boost your business learning with challenging short courses for entrepreneurs at London's global university
12 March 2014
We are pleased to announce the launch of 5 new short courses for entrepreneurs
- Sales Strategy
- Financing Entrepreneurs – How to raise your first seed investment
- Recruiting & Managing your First Employee
- Managing Supply Chains
- Pitching Skills
The courses look to address the concerns of small business leaders, start-ups and anyone simply looking to learn more about small business management and entrepreneurship.
Delivered by experienced trainers and hosted by UCL Advances, these CPD certifited courses provide participants with an engaging and interactive classroom experience and attract businesses, academics and post-graduate students alike.
Find out more and book your place on a short course
N.B. If you are a Mobile Academy or 10ksb alumni, or a UCL Advances Mentor/Mentee, you receive a 50% discount off the standard short course fee.


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October 1 - December 30, 2014 | Sunday - Thursday
Show your Rewards Club Card and save $10.
October 1 - December 30, 2014
Receive $20 Rewards Play, Tanger Outlet Shopping offer, and Shopping Bag. Up to 4 persons in room. Select Rooms.
December 31, 2014
Receive Rewards Play, Gift, Concert wristband. Resort Credit for two.
*Package must be requested at time of reservation, not available at check-in. Must present Rewards Club Card to qualify for package at time of check-in. Cannot be combined with any other offer. No blackout dates.
January 1 – April 30, 2015
Special Price. Receive $60 rewards play (issued In $10 increments, up to two guests),
Plus one BOGO drink offer. Up to two guests per room.
January 1 – April 30, 2015
Special Price. $25 Rewards Play (up to 2 guests each), Complimentary chocolate.
Special spa offer. Champagne available for additional charge.
See Hotel Offer Rules & Regulations
Packages: Additional cost for weekends and holidays. Guests are responsible for tax and fees.


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East Texas School Closings + Delays: Tuesday, March 4
Icy, slick roads are still a concern for East Texas school districts for the start of school on Tuesday, March 4th. We have the latest on school closures and delays for Tuesday here.
Icy, slick roads are still a concern for East Texas school districts for the start of school on Tuesday, March 4th. We have the latest on school closures and delays for Tuesday here.
Old man winter rears his ugly head once again bringing rain, thunder, lightning, sleet, freezing rain and some snow flakes to East Texas Sunday afternoon and evening and with temperatures near freezing in some areas and well below in others, some school districts in East Texas are opting to delay the start of classes for Monday or cancel them all together. Get the latest list of school closings right here.
It appears as if East Texas isn't getting spared when it comes to the wintry mix. Rain, freezing rain, sleet and snow are expected this afternoon through this evening and will most definitely be causing problems tomorrow morning. Some school districts are making decisions now to either delay the start of classes on Wednesday or cancel them all together in addition to affecting athletic plans Tuesday evening.
It appears as if Punxsutawney Phil's prediction is coming true from Groundhog Day, East Texas is once again experiencing cold weather and with that winter precipitation too and threatening to delay or cancel classes on Tuesday.
Winter weather is once again threatening parts of East Texas and bringing joy to kids in its path because of the potential of snow and ice, some East Texas school districts are opting for a delayed start or even cancelling classes completely.
Winter weather is once again bringing joy to kids throughout East Texas because of the snow and ice that's predicted for parts of East Texas several school districts have opted for a late start or even cancelled classes completely in some cases.
Winter weather has arrived before the official start of winter and with the snow and ice that's expected in parts of East Texas, we'll keep you up to date on school closures and delays.
For Wednesday, February 9th:
ALBA-GOLDEN ISD - 11am dismiss
ALTO ISD - 11:30am dismiss
ARP ISD - 12noon dismiss
BIG SANDY ISD - 12noon dismiss
BROOKHILL SCHOOL - 12:30pm dismiss
EAST TEXAS CHRISTIAN SCHOOL - 10am dismiss
ELKHART ISD - 1pm dismiss
GILMER ISD - 12noon dismiss
HARMONY ISD - 10:15am
JACKSONVILLE ISD - 1pm dismiss
KILGORE ISD - 1:30pm dismiss
LINDALE ISD - 12noon dismiss
MARSHALL ISD - 12:30 dismiss


text: > From: Jim Davis > > http://www.jimdavis.org/test/header.htm > > This uses a hack for IE to make it think it knows about > min-width. Hack courtesy of Project Seven > <http://www.projectseven.com/> . Thanks Jim. I had a similar test setup but was unhappy with the way the header swells away from the logo graphic at the largest text sizes. I am trying to avoid non-basic markup and styles too so the min-width javascript for IE isn't appealling. I think I'm going to live with the header as I've got it now it seems to work satisfactorily through sensible page resizes and text size changes. Thanks all who have contributed thought/ideas :-) Greatly appreciated. -- Peter Williams ______________________________________________________________________ css-discuss [EMAIL-REMOVED]] http://www.css-discuss.org/mailman/listinfo/css-d List wiki/FAQ -- http://css-discuss.incutio.com/ Supported by evolt.org -- http://www.evolt.org/help_support_evolt/


text: FILIPINO ATTACK NEAR CALOOCAN - Large Forces of the Insurgents Repulsed by Our Troops. THREATEN TO BURN MANILA Otis Issues an Order Warning All Suspects and Incendiaries. Sharp Engagements with the Enemy in the Suburbs, Accompanied by Severe Artillery Fire. - View Article - NYTimes.com Your browser does not support iframes. Please use this link to view your article: view article.


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Have Parenting Questions? Ask a Parenting Counselor for Answers
You can use either language. It is at an early age that children learn languages. You don't need to worry about confusing him.
Even if it causes him to mix both languages in the same sentence? I do not, but He does not make the distinction and mixes it up sometimes.
Just nicely correct him and the benefit will be that he will be bilingual.
He'll get it together as he grows older.


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Bloons TD 5
The latest and long awaited part of the Bloons Td Saga.
Bloons TD 1
The first part of the addicting Series. Its a basic Tower Defense Game which offers hours of fun.
Bloons TD 2
The second part of the Series may be seen as an upgrade of the first Game.
Bloons TD 3
This really is a breakthrough for Fans. The 3rd part brings massive improvements and alot of new tracks.
Bloons TD 4
The 4th part really is the best part of the Bloons Saga. A lot of improvements have been made. This is one of the best Tower Defense Games of all times.
Bloons TD 4 Expansion
The Expansion to Bloons TD 4 brings 4 new tracks along with a new game mode. Unlock the Secrets of the Sun Gods Temple. You may use multiple strategies by using the new Tower Specialties.
Bloons 2
The long-awaited 2nd part of the classic. More levels, more bloons, more addicting hours of flash gaming mania.
Bloons Super Monkey
Your no monkey, you are a Super Monkey. It is time to pop the balloons in this great vertical shooting game. Make your brain spin and the bloons popping.
Bloons 2 Christmas Expansion
Every monkey will put on his Santa hat and play Bloons 2 Christmas Expansion during winter time.
The beginning of the bloons hysteria.
Bloons Insanity
50 new challenging Levels for Bloons.
If you like Tower Defense Games you have certainly heard or played a Game of the Bloons TD Saga. If not take your chance and try them today.
If you are not familiar with Tower Defense Games take a look at Tower Defense on Wikipedia. In short Tower Defense Games evolved out of the RTS (Real Time Strategy) Games Genre. In many classic Games like Dune 2, Command & Conquer and Warcraft many players enjoyed building paths of Towers and Walls. Once the enemies entered these traps of Walls and Towers they easily got beat up. Later the Tower Defense Genre saw its official birth out of the RTS Genre.
Bloons Games generally are build around the basic story that there are hostilities between Monkeys and Balloons. The Monkeys are armed with darts and other weapons and are trying to go after the Balloons. All Games are free online Flash Games and have been developed by Ninja Kiwi. All parts are based on the simple idea that popping balloons can be funny. This simple game idea has found masses of players over the years. The Games are suitable for every age. Be careful once you start playing Bloons TD Games you may get addicted too.
To start you may try the first part Bloons TD 1. Check out the latest release Bloons TD 5. This game really is the climax of the whole Series. Well done and a must play for each Bloons Fan.
Star Wars Games


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Kent's Joseph Apostol progresses on The Voice
PUBLISHED: 09:02 28 May 2013 | UPDATED: 09:34 28 May 2013
WARNING: Use of this copyright image is subject to the terms of use of BBC Pictures' Digital Picture Service (BBC Pictures) as set out at www.bbcpictures.co.uk. In particular, this image may only be published by a registered User of BBC Pictures for editorial use for the purpose of publicising the relevant BBC programme, personnel or activity during the Publicity Period which ends three review weeks following the date of transmission and provided the BBC and the copyright holder in the caption are credited. For any other purpose whatsoever, including advertising and commercial, prior written approval from the copyright holder will be required.
Gillingham youngster makes it to the next round
MidKent College student Joseph Apostol has made it through to the next round of the popular BBC One talent show The Voice.
The music pupil, 21, from Gillingham, was successful in Saturday's battle round clash with pop duo Diva, with the two acts performing the Elton John classic Don't Let the Sun Go Down On Me.
Apostol will now progress to the knockout stage, which is just one step away from the live shows judged by the general public.
Head of faculty at the college Louise Molton said: "Joseph is such a lovely young man and we are absolutely delighted to see him doing so well in the competition.
"All his friends and lecturers here at the college have been glued to our television screens and giving him support through text messages, emails and on social media.
"We'll be keeping our fingers crossed that he gets through the knockout stage so we can all jam the telephone lines once we receive our chance to vote."
Joseph has already performed several times in front of staff and students at MidKent College, including at the opening of the Medway Campus' new soundproof live room last November.


text: Safeguard your phone, save money and regain your peace of mind with the new way to ensure your phone, and everything on it, stays with you. Available for both iPhone and Galaxy S, Proximo makes every day easier by ensuring you never lose your phone in the first place. The Proximo Fob works with the free App on your phone, alerting you as soon as your phone or keys get too far away from each other.


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There are simple, but difficult to recreate reasons why the US has been so successful economically. There are advantages on the supply and on the demand side. Let's start with the former first.
The US was the first to mass educate its population, it had excellent technical colleges, the GI bill after WWII was revolutionary and its top universities are the best in the world (still). Its innovation system, where universities and research institutes have good relations with business, has been a model for many countries to follow. The country is pervaded by a can-do mentality and bankruptcy isn't necessarily the life-long burden it is elsewhere.
The government was sponsoring fundamental research, research with the widest possible applications, which shouldn't be owned by any single company as many companies should get in on developing different aspects. This they did through universities and defense (DARPA). The innovation system in the US was, and continues to be, top notch, the envy of the world.
On the demand side, the US is blessed with a large internal market, where producers could reap important economies of scale and scope. Even if other markets are growing faster now, the US market is still the largest in the world today (the EU single market is still a work in progress, especially for services).
That huge American market was driven by domestic consumption (unlike today's China, which is much more investment and export driven). For decades, the US consumer was the proverbial consumer of last resort. Whenever the world economy got into trouble, as long as America started to consume again, things would turn out okay.
The size of the domestic market matters. Jeff Madrick wrote a convincing book titled 'Why Economies Grow,' in which he argues that the size of the domestic market has been the decisive factor in economic leadership in history. This passed from Spain to the Netherlands to Great Britain to the US, to a large extent because the size of their markets allowed for a finer division of labor, economies of scale and scope, allowing producers to recoup the fixed cost of technology development.
End of consumption led economic growth?
But just as China has to rebalance economic growth toward more domestic consumption and away from investment (export dependency adjustment is already well on its way), the US has to rebalance its economy away from personal consumption.
It looked like this was going to happen as a result of the financial crisis. Households were deleveraging, paying off debt which was left after the collapse in house prices left them with enormous mortgage debt and they had to repair their balance sheets (or at the minimum, there was a wealth effect operative).
However, the latest GDP figures show that this deleveraging process might already have come to an end:
In 2011, growth in personal consumption expenditures accounted for 1.54 percentage points of the 1.7 percentage points of economic growth. In the first quarter of 2012, they contributed 2.04 percentage points to the overall growth rate of 2.2 percent. Translation: The level of consumer activity is rising and driving growth to a much greater degree than it was last year. [Daniel Gros]
The somewhat curious thing is that public spending, despite all that talk of a "government out of control," was a considerable drag on the economy.
So in 2011, declines in government consumption sapped economic growth by .44 percentage points. But in the first quarter of 2012, contraction in the government sector took a bigger bite out of growth-subtracting .6 percentage points from the growth rate. [Daniel Gros]
But there was something more worrying:
The reduced savings rate, from $466.0 billion in the first quarter compared with $530.8 billion in the fourth (or 3.9 percent in the first quarter compared with 4.5 percent in the fourth), means more contribution to GDP in this measurement period, but it also means less stability for the long term. One of the problems of the economic boom from the 1980s through the 2000s was that it was build in part on a declining savings rate. [Anthony Randazzo]
Now, while those saving numbers are residual and therefore a little dubious, if confirmed this would be a worrying trend. Low savings is one of the things that got us into trouble. On the other hand, adjustment to a higher savings rate will, if nothing compensates the move, produce a recession of epic proportions.
What could compensate higher household savings is increased business investment, increased net exports, and/or increased public expenditure, but none of this is happening.
Despite all that talk of a "government out of control," public spending was a considerable drag on the economy.
So in 2011, declines in government consumption sapped economic growth by .44 percentage points. But in the first quarter of 2012, contraction in the government sector took a bigger bite out of growth-subtracting .6 percentage points from the growth rate. [Daniel Gros]
And why would business invest more when they already have overcapacity and demand for products and services would decrease as a result of increased household savings?
So any adjustment process towards more household savings is going to be extremely painful economically. However, we believe that there are structural shifts in the economy that will nevertheless make it happen. There were several waves of increases in consumption that now seem to have run their course:
- Babyboomers are retiring
- The great expansion of double income families is now in retreat (as a result of the employment crisis)
- The 'democratization of credit' has produced such excesses that it will take considerable time to get us there again
- Houses are no longer considered the safe piggybanks from which equity could be withdrawn at will
One big uncertainty is what will happen to ever increasing income inequality, as this has been a big driver for credit demand. If median wages remain near stagnant as they have been for several decades, either consumption will fall as most of the additional income that is created is going to the top which proportionally consumes less, or new forms of credit will be developed to 'remedy' this.
That doesn't seem very sustainable. The shift from low to high earners and from labor to capital cannot go on forever. It's no wonder most households are saving so little. They've shared very little in the wealth creation since the 1970s.
Click to enlarge
The US has enjoyed a century of unprecedented growth, but part of the model on which this is based is running out of steam. Structural shifts will notch the economy away from the near complete reliance on household consumption, but that adjustment process is going to be very painful if nothing replaces the decrease in demand, already way beyond what the economy can produce as a result of the financial crisis.
While public spending in the US is low compared to other developed countries, there seems little appetite for an increase and the budget deficit is already very large anyway. But alternatives to fill the demand hole aren't very likely. Business isn't going to spend more in the face of lower demand and exports depend largely on the world economy.
We have long argued that some sort of restoration of 'Fordism,' that is, restoring the link between wages and productivity growth is necessary. But that would require a shift from the present low wage driven growth and seriously addressing the rising inequality. At present, the top 1 percent gets a disproportional part of additional income created (93% in 2010!).
But much more would be needed for such a recalibration of the US economy, like a wholesale overhaul of the secondary education system. We'll leave that for some other time.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.


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Digits Live Show: Twitter Rolls Out Ads
Twitter will start rolling out advertising to users today as it attempts to turn its microblogging service into a profitable business. Stacey Delo talks with Jessica Vascellaro in San Francisco. Plus, a Preview of Intel & AMD quarterly earnings.
Previously on the Digits Live Show
Follow @staceydelo on Twitter


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Neelam Sahota dished out 26 assists to go with 19 digs and four kills as the Tokay Tigers varsity volleyball team picked up its first league win, 25-18, 27-29, 25-19, 25-18, over the West Wolf Pack in Tracy on Thursday.
Emily Schneider had 12 digs, while Rebekah Boron-Trotter 15 digs, five kills and three aces. Geovanna Quilantang had 21 digs, three aces and four assists.


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Britney Spears to follow through with wedding
Britney Spears is not having cold feet about her wedding to Jason Trawick.
The pop star is currently engaged to entertainment agent Jason.
Britney was spotted out without her engagement ring recently which ignited rumours that she may call off her marriage.
Sources say that this simply isn't true as the pair are very much in love.
"She was not wearing her ring last week at court because she took it off during an Elizabeth Arden [photo] shoot and Jason was holding it for her. He simply forgot to give it back until later," an insider told People.
"There's no truth to any second thoughts about their wedding. They're fine and both look forward to working again when The X Factor gets started. They've had a great summer."
Britney was previously married to backup dancer Kevin Federline, whom she shares two children with.
She considers her union with Jason to be more valuable than her former relationship.
"Even though Britney has been married before, she looks at her wedding to Jason as her real wedding," the source said.
Britney and Jason have been engaged since last December.
© Cover Media


text:
- Admissions
- Academics
- Research
- University Life
- Alumni
- About
USPS Hiring Event
Off Campus
The United States Postal Service will hold a hiring event on Thursday, January 23 at the Arlington Employment Center.
The USPS is currently seeking (in NoVa including Arlington, Alexandria, Merrifield, Reston): City Carrier Assistant, Rural Carrier Assistant, Motor Vehicle Operator, Automotive Technician.
·Must successfully pass a pre-employment drug screening
·Must be U.…more
Type: Fair
Host: Career Center
Finding Part-Time Employment
Hughes Formal
The job search process can be intimidating. Fortunately, Career Center and Human Resources staff are available to guide students every step of the way. Come learn where to find a part-time job on or off campus or earn your Federal Work Study award. Also learn more about the application process and how to become a stronger applicant by utilizing Career Center services and resources.
Type: Lecture/Speaker
Host: Career Center
Drop-in Career Advising
Career Center Library
Receive quick advice about your resume, cover letter, or job and internship search without having to schedule an appointment. Drop by to speak with a SOC Career Advisor.
Type: Table/Display Case
Host: Career Center
Go Gov: Security Clearances and Your Job Search
Mary Graydon Conference Room 203
Candidates for federal employment must participate in security clearance measures to ensure that they are "reliable, trustworthy, of good conduct and character, and loyal to the United States" (gogovernment.org). If you are interested in applying for federal positions, attend this Career Center workshop, led by Liz Newman, Esq. (WCL '04), litigation director at The Jeffrey Law Group, to learn …more
Type: Lecture/Speaker
Host: Career Center
Green Corps Information Session
The Gianni Lounge (Mary Graydon Conference Room 200)
The Career Center will host Green Corps for an information session on Thursday, January 30, 6:00 p.m. to 7:00 p.m., in MGC 200.
Green Corps is a non-profit organization that trains future environmental and social change activists. A representative will provide an overview of the organization and discuss their year-long paid field organizer position.
Please log into AU CareerWeb or Kogod …more
Type: Information Session
Host: Career Center
Deloitte Consulting Case Interview Workshop
Mary Graydon Conference Room 3
The Career Center will host Deloitte Consulting for a case interview workshop on Thursday, January 30, 6:00 to 8:00 p.m., in MGC 3 and 4.
The event will be a combined undergraduate and graduate student event. If you have never been through a case interview and are applying for the Deloitte Summer Internship or Summer Associate Programs, this is a helpful event for you to attend.
Speakers will …more
Type: Information Session
Host: Career Center
Drop-in Career Advising
Career Center Library
Receive quick advice about your resume, cover letter, or job and internship search without having to schedule an appointment. Drop by to speak with a SOC Career Advisor.
Type: Table/Display Case
Host: Career Center


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On the 30th anniversary of John Lennon's death, Yoko Ono writes a touching tribute to the singer to remember her happiest moments with him.
Yoko Ono has paid a touching tribute to her late husband John Lennon on the 30th anniversary of his death, recalling the happy times she shared with The Beatles legend before he was killed. The "Imagine" hitmaker passed away 30 years ago on 8 December, 1980 after he was gunned down outside his New York apartment in The Dakota building by deranged fan Mark Chapman.
Ono has marked the date by remembering her happiest moments with the singer - sipping Lennon's favorite tea and laughing like teenagers together. In a post on her Imagine Peace website, she writes, "John and I are in our Dakota kitchen in the middle of the night... 'Yoko, Yoko, you're supposed to first put the tea bags in, and then the hot water.' John took the role of the teamaker, for being English. So I gave up doing it. It was nice to be up in the middle of the night, when there's no sound in the house, and sip the tea John would make."
"One night, however, John came up with 'I was talking to Aunt Mimi this afternoon and she says you are supposed to put the hot water in first. Then the tea bag. I could swear she taught me to put the tea bag in first, but...' 'So all this time, we were doing it wrong?' 'Yeah...' We both cracked up. That was in 1980. Neither of us knew that it was to be the last year of our life together."
"On this day, the day he was assassinated for being a truth seeker and a communicator, what I remember is the night we both cracked up drinking tea. They say teenagers laugh with a drop of a hat. But nowadays I see many teenagers angry and sad at each other. John and I were hardly teenagers. But my memory of us is that we were a couple who laughed."
In related news, a legal letter which is said to have led to the break-up of The Beatles is up for sale. The document, signed by John Lennon, Ringo Starr and George Harrison, is addressed to Sir Paul McCartney's lawyer father-in-law Lee Eastman and effectively fired him as the band's legal counsel.
Dated 18 April, 1969, the letter reads, "you are not authorized (sic) to act or hold yourself out as the attourney (sic) or legal representative of The Beatles," and requests all documents related to the band be forwarded to manager Allen Klein. Eastman, the father of McCartney's late wife Linda, managed the musician and acted as the band's lawyer, but a disagreement between the group members led to his dismissal.
The argument is said to have driven a wedge between McCartney and his bandmates, which eventually led to the band's break-up in 1970. Independent Beatles memorabilia dealer Peter Miniaci tells the New York Post the letter will be a must-have item for devoted collectors, saying, "It's a million-dollar item. It's John sending a message to Paul and Lee that he didn't want Eastman managing the band. So then the Beatles became a divided camp. It was a colossal mistake because Klein ended up taking advantage of the band, and it was dismantled shortly after the letter came out."
The letter has a $175,000 price tag and is for sale on curator Gary J. Zimet's website Momentsintime.com.


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Desire2Learn (D2L) is the web-based learning environment supported by MTSU. Students should contact their instructors to learn if D2L will be used for their courses.
To login, use your PipelineMT username and password.
For online assistance, visit the D2L Support Page. For additional assistance, contact the ITD Help Desk at 898-5345.
Please click here for a System Check before you login.


text:
When the creator of Harry Potter decides to build an adventure playground for her children, you expect something magical.
But even by JK Rowling's standards the 40ft high, two-storey tree houses planned for the back garden of her Edinburgh mansion are something spectacular.
The Hogwarts-style towers - estimated to cost around £150,000 - are so big that they need planning permission.
JK Rowling plans 40ft high adventure treehouse for children in back garden of Edinburgh mansion
Current Status: Published (4)
Seeded on Wed Jul 25, 2012 4:31 AM
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1/10A man and woman kiss passionately for a couple of seconds and she takes off his bed. There is an action scene following this and this is close to nothing as they are both clothed.
A few scenes of long, realistic MMA style fighting.Several fight scenes are particularly vicious, with both a female character and various male characters being punched and hit with objects.At the conclusion of one particularly violent fight between a man and a woman, the woman, after having knocked her opponent senseless, proceeds to cold-bloodedly cover his face with a pillow and shoot a gun through the pillow, killing the man. The pillow hides the gore.
Seven uses of "sh*t" and two uses of "f*ck". More uses of small language throughout.
Find showtimes, watch trailers, browse photos, track your Watchlist and rate your favorite movies and TV shows on your phone or tablet!


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Napa Truffle Festival - Truffles & Wine Dinner at La Toque
Napa Truffle Festival
Event Details
Napa Truffle Festival
Truffles & Wine Dinner at La Toque
Saturday, January 18, 2014
6:30pm-7pm Check-in & Reception
7pm-10pm Dinner
Hotel accommodations are not included in the above pricing but special rates are available at Westin Verasa Napa. Must be 21 years or older to attend. Pricing is per person and includes all taxes and gratuities.
Check-in for the Truffles & Wine Dinner is at:
La Toque
1314 McKinstry Street
Napa, CA 94559
We look forward to seeing you at this incredible dinner!
Refund Policy: Before December 17, 2013, we offer full credit that may be applied towards the 2015 festival, or a 50% cash refund. As of December 18, 2013, we offer a 65% credit applied toward 2015. No cash refunds after December 18, 2013.
La Toque
1314 McKinstry Street
Napa Truffle Festival
Having difficulties? Contact the Napa Truffle Festival at firstname.lastname@example.com or (888) 753-9378.


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If you haven't come across Kiip in a mobile video game adventures, the chances are you will soon.
The two-year-old San Francisco software company is building out its mobile games reward network. When it launched in April 2011, Kiip (pronounced "keep") had on board nine games that incorporated its rewards program with coupons from 10 brands including Popchips, Dr Pepper, Carl's Jr. and VitaminWater.
Today, there are more than 400 Kiip-enabled games and apps, including Unblock Me, Zombie Farm, Mega Jump and Tank Attack. Among the more than 40 companies using its reward program are 1-800-Flowers.com, American Apparel, Best Buy, Disney and Procter & Gamble, Dr Pepper, PepsiCo and Sony Music.
Story and video: See Kiip CEO Brian Wong and Kiip in action & read about small businesses using gamification.
Kiip's ads aren't like most. Rather than pop up randomly and obscure the already-tiny screen, their ads are reward coupons that appear in the flow of the game. After setting a new high score or finishing a level, you might get a free bag of Popchips, $5 off your next Amazon.com order or 30% off your next purchase at ProFlowers.com.
Last week, Kiip launched a new "Kiipsake" digital wallet app for Android -- the iOS version is awaiting App store approval -- that lets players search for other Kiip-enabled apps and store their rewards rather than forward them to their e-mail accounts.
A desktop Kiip app is in the works, and its reward program is moving beyond games to non-game activities. The first application, tested this spring, gave users of the Map My Run app free bottles of Pepsi's Propel Zero fitness water.
"This concept is almost like science fiction," says Kiip CEO Brian Wong. "I could run eight miles and get a free bottle of Gatorade. I could finish playing a game and get a bag of Skittles. I could browse a bunch of shoes and get a gift card to buy something on Amazon. All these activities that should lead to a mutual and beneficial relationship through some kind of targeted relevant reward has never really been possible until now."
When he co-founded Kiip two years ago, Wong wanted to revolutionize mobile advertising. Smartphone games were exploding, but "dissecting every game I could find," Wong says, he came to the conclusion that most current in-game ads were "abysmal."
A mobile game player himself, Wong knew that all games have celebratory moments when the player sets a new personal high score or gets past a particularly tough challenge. "The idea hit me," he says, "What if we could reward people with physical things as they leveled up in a game they were already spending time playing?"
Those stoppages could work as organic advertising opportunities. "You are happy, and there's this natural pause in play," he says. "It's this magical moment that a lot of people had overlooked."
Healthy snack maker Popchips were early adopters of Kiip's program. To kick off its partnership with Kiip, Popchips decided to give away 750 boxes that included bags of all the company's various popped potato chips. Mobile gamers were a perfect viral target for Popchips, says Brian Pope, Popchips' senior vice president of marketing.
"The way we are trying to connect with people is one on one. We do it through our field marketing teams with grass-roots marketing at a lot of events," he says, "where we can meet people, introduce them to Popchips and encourage them to try a bag. What we saw in Kiip was the way to maintain that exact same philosophy. Kiip gave us within the mobile environment a way to do kind of the same thing we were doing in the physical world."
Popchips has continued its relationship with Kiip as it expands into the United Kingdom and prepares to launch new popped tortilla chips. (Popchip fans can look forward to four flavors: nacho cheese; ranch; chili limon; and salsa.) "We are hoping that we remain nimble enough to identify these cool companies like Kiip and get in early on and try some things out before the big boys catch on," Pope says.
Fueling Kiip's expansion is $11 million in venture-capital funding from Relay Ventures and previous investors Hummer Winblad and True Ventures. How Wong has "put all this pieces together and gone after a brand-new market is extremely compelling to the investor community," says Lars Leckie, a managing director at Hummer Winblad.
True Ventures staked Kiip with its initial funding of $300,000 in 2010, Wong and co-founders Courtney Guertin, who became chief technology officer, and creative director Amadeus Demarzi built a program that lives within a game and signals when a rewards-worthy moment is happening.
The company transmits about 100 million rewards in mobile games each month in the U.S. From 18% to 22% of players redeem awards, and that rate increases to 50% for return rewardees.
To help encourage small game developers, Kiip has established a $100,000 fund to help them get on board. Its code is made available for free so small, independent game developers can add it to their games.
As the company expands to more games and beyond games, "the concept of Kiip now all of a sudden overnight became much more than (what it was) day one when we launched, which was rewards for playing games," Wong says, "It became rewards for doing the things you already do every day."
Mike Snider began covering the video game industry during the Super Nintendo-Sega Genesis clash in 1992. An original pinball wizard, he eventually was seduced by Robotron: 2084 and Tempest. These days he is a fan of action/shooters and lives out his Keith Moon fantasies playing a mean drum kit on music games. More about Mike.
Brett Molina has been writing about video games for USA TODAY since 2005. He is well-versed in Madden NFL, the fighting genre and first-person shooters. The first video game he played was Asteroids at a local arcade. He has been hooked ever since. More about Brett.


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WHISKEY oldfashioned wet shave jelly by portlandgeneralstore
What would Sam Elliott shave with? Whiskey. Straight up.
Thought these were clever and fun earrings.Tags: wood, red, fire, matches, Valentine's, unusual jewelry, unique valentine gift, you light me up, jenecklund designsAdded 6 Years Ago from Etsy
Its perfect, TN London.Tags: fashion, style, leather, jewelry, metallic, pins, accessories, brooch, Valentine'sAdded 6 Years Ago from Etsy
I love these, they can be personalized. I can imagine telling someone, I love to hate you or let's get it on.
Valentines and Chinese New Year are around the corner. What to wear, hmmm, I would like to start with the beautiful lower brooch made of red hand-dyed silk.
Just love this.Tags: fiction, gifts, literature, love, romance, literary, Classic, Jane Austen, dayAdded 7 Years Ago from Etsy
Apple Blossom prints makes these sweet customizable prints. They make a wonderful Valentine's Day gift. And you can choose your own colors.Tags: art, print, love, design, Valentines, Valentine's, couplesAdded 7 Years Ago from Etsy
Sweet and a bit mysterious handcrafted brooch from Metal Designs on Etsy.
Would make such a sweet gift!
Love these crafty little tags that will spruce up everything from a bottle of wine to a box of chocolates.
Props to Sweet Stella for creating the sweetest little accessories around.Tags: gifts, accessories, jewelry, candy, handmade, sweets, heart, day, ValentinesAdded 7 Years Ago from Etsy
Sweet stuff around the cuff.
I don't need to write a recommendation... just look at the picture. Awesome.
Say it with a very fine handcrafted note from the crew at fabulous Igloo Letterpress.Tags: vintage, handmade, cards, love, Etsy, notes, letterpress, Valentines, ohioAdded 7 Years Ago from Etsy
Give 'em a big kiss :)Tags: vintage, handmade, cards, love, Etsy, notes, Valentines, x o x o, Valentine'sAdded 7 Years Ago from Etsy
Perfect for your Valentine, Ruby Red Vintage Glass Heart Earrings. Available at http://www.etsy.com/shop/crystallullabyTags: jewelry, vampires, Valentine's, ruby red, Twilight, heart earrings, blood red, vintage glass, estate styleAdded 7 Years Ago from Etsy
Gorgeous Knuckle Duster Ring handcrafted in Austin Texas. Perfect statement jewelry piece with giant Citrine specimen over 400 Kt weight! Made by Chase and Scout for Austin Modern, their jewelry has appeared in Daily Candy, Aus... Gorgeous Knuckle Duster Ring handcrafted in Austin Texas. Perfect statement jewelry piece with giant Citrine specimen over 400 Kt weight! Made by Chase and Scout for Austin Modern, their jewelry has appeared in Daily Candy, Austin Monthly, Palm Beach Living, and PaperCity Magazine.
♥Ruby Red and sexy~ These lips are ready for lots of affection this Valentine's Day! Made of hand cast resin and glitter beads. This item ships FREE if you reside in the United States. Get yours today and have it in time for V-Day... ♥Ruby Red and sexy~ These lips are ready for lots of affection this Valentine's Day! Made of hand cast resin and glitter beads. This item ships FREE if you reside in the United States. Get yours today and have it in time for V-Day! ♥This necklace has the option of coming with either a silver shiny ball chain, OR you may pick a ribbon necklace. Use the last photo to pick from either A-B-C. Please leave a message to seller upon checking out. ♥Like this style, but would like it to have something else written inside? Please, feel free to convo me for a special custom request, I can create this in a heart or any other shape you would like! The price will remain the same for your request. :] ♥♥Your necklace will arrive carefully gift wrapped with love, and placed into a pretty red organza gift bag, ready to keep or to share this Valentine's Day!♥♥ ♥All corners have been dremeled down and then also hand sanded.I've also hand polished them for extra shine and sparkle.My pieces are never sticky or tacky.
A unique little accessory for the home. This mason jar stores sunlight, and casts a subtle glow later in the night.Added 8 Years Ago from Amazon.com
also available, zombie bunnies!
This would be an adorable Valentine gift & who doesn't love cupcakes?Tags: gifts, flowers, cupcakes, pink, handmade, strawberry, Etsy, Valentine'sAdded 8 Years Ago from Etsy
Why are your pants still on? That is what I want to know, Happy Valentines!
Cute idea & a great gift for Valentine's, anniversary or an unusual wedding present?Tags: handmade, love, wedding, trees, hearts, Etsy, Valentine's, couples, anniversariesAdded 8 Years Ago from Etsy
Aw! So cute and just in time for Valentines ..this is just adorable <3
This would a cute little trinket bowl & a special little gift...Tags: pink, handmade, black, bowls, hearts, Etsy, household items, Valentine's, felted stuffAdded 8 Years Ago from Etsy
This would make a great & unusual Valentine's Day giftTags: handmade, print, Etsy, Valentine's, Cool HuntingAdded 8 Years Ago from Etsy
great for valentines!Tags: necklaces, heart, love, Valentine's, message in a bottleAdded 8 Years Ago from Etsy
A feathered heart headband in soft pink with Swarvoski crystals... how sweet can it get. Too cute!
This headband is def head over heels. Feathers in her hair so romantic.
I'm as jaded as you think that I am.