True statement about phase 2 clinical trial is:
Large number of healthy volunteers are studied
Used to determine maximum tolerated dose
Used to determine efficacy
Used to determine toxicity
Phase II Clinical trial This is conducted by physicians who are trained as clinical investigators and involve 100-500 patients. The primary aim is the establishment of therapeutic efficacy, dose range in a controlled setting. Tolerability and pharmacokinetics are studied as an extension of phase I. they are single-blinded studies Ref; KD Tripathi pharmacology 7 th edition (page no; 80)
General pharmacology