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What is Good clinical practices (GCP) are not a pa of:- and explain in detail?
Pre - clinical trials are performed on animals (lab - experiments / lab - trials), so good clinical practices (GCP) are not required. Phase I (healthy human volunteers), Phase II, III, IV (patients) require GCP. Phase Unit of study Purpose PRECLINICAL PHASE Lab experiments Animals Pretesting CLINICAL PHASE Phase 0 Healthy human volunteers Micro - dosing Phase I Healthy human volunteers Safety and non - toxicity profile Phase II Patients Effectiveness Phase III Patients Comparison with existing drugs Phase IV Patients Long term side effects