Phase II in a clinical drug trial is
Human pharmacology and safety
Therapeutic exploration and dose ranging
Therapeutic comparison
Post marketing surveillance.
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.
General Pharmacology