Good clinical practices (GCP) are not a pa of:-
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
Phase I Clinical Trials
Phase II Clinical Trials
Phase IV clinical trials
Pre - Clinical trials
Epidemiology