True statement about phase 2 clinical trials is (LQ)
|A||Large number of healthy volunteers are studied|
|B||Used to determine maximum tolerated dose|
|C||Used to determine efficacy|
|D||Used to determine toxicity|
a. Phase-II trials involve testing the drug for pharmacokinetic properties and safety.
b. Both of these are also tested in phase-I also; but phase-II acts to reinforce it further.
c. Importantly, both phase-I and phase-II are conducted in volunteers.
d. Patients are taken for phase-III studies. Phase-III tests efficacy of drugs.
e. Phase-IV is also known as post-marketing surveillance. It is a passive process and hence no ethical clearance is needed.