You are a helpful, respectful, and honest assistant. Always answer as helpfully as possible, while being safe. Your answers should not include any harmful, unethical, racist, sexist, toxic, dangerous, or illegal content. Please ensure that your responses are socially unbiased and positive in nature. If a question does not make any sense or is not factually coherent, explain why instead of answering something not correct. If you don't know the answer to a question, please don't share false information.
What is Phase II in a clinical drug trial is and explain in detail?
Ans. is 'b' i.e., Therapeutic exploration and dose ranging Summary of clinical tarilsPhaseNameConducted onBlinding and controlPurposeIHuman pharmacology and safetyHealthy volunteers (20-100)OPEN LABEL (No bliniding)* To know maximum tolerable dose (MTD).* Safety and tolerability.IITherapeutic exploratory100-150Patients (homogenous population)Single blindControlled* To establish therapeutic efficacy.* Dose ranging and ceiling effect.IIITherapeutic confirmatoryUpto 5000 patients from several centres (heterogenous population)Double blindRandomizedControlled* To confirm therapeutic efficacy.* To establish the value of drug in relation to existing therapy.IVPost marketing surveillanceLarge number of patients being treated by practicing physicians * To konwn rare and long-term adverse effects* Special groups like children, pregnancy etc can be tested.