Stage 4 clinical trial also called as ?
Ans. is 'b' i.e., Post marketing surveillance Summary of clinical tarils Phase Name Conducted on Blinding and control Human pharmacology Healthy volunteers OPEN LABEL and safety (20-100) (No bliniding) lI Therapeutic 100-150 Single blind exploratory Patients (homogenous population) Controlled Therapeutic Upto 5000 patients Double blind confirmatory from several centres Randomized (heterogenous population) Controlled IV Post marketing surveillance Large number of patients being treated by practicing physicians Purpose o To know maximum tolerable dose (MTD). o Safety and tolerability. o To establish therapeutic efficacy. o Dose ranging and ceiling effect. o To confirm therapeutic efficacy. o To establish the value of drug in relation to existing therapy. o To konwn rare and long-term adverse effects. o Special groups like children, pregnancy etc can be tested.
Human pharmacology and safety
Post marketing surveillance
Therapeutic exploration and dose ranging
Therapeutic confirmation