Approximate number of patients recruited in phase II clinical trials of a drug are?: (A) 20-100, (B) 100-500, (C) 500-1000, (D) 1000-5000
Answer is A. Phase Name Conducted on I Human Pharmacology and safety Healthy Volunteers II Therapeutic Exploratory (20-200) patients III Therapeutic Confirmatory Upto 5000 patients from several centres IV Post-Marketing Surveillance Large number of patients 0 (ZERO) Microdosing studies Healthy volunteers (Small numbers)