Wednesday, 15 January 2014

Clinical trials

Clinical trials
Phase 1: in normal human volunteers (mainly for toxicity n pharmacokinetics)
Phase 2: smal no of patients (20 -200), first in patient study, (both efficacy n safety can b determined.
Phase 3: large no of patients at several centres
Phase 4: post marketing surveillance.
 Recently phase 0 has been added to expedite d marketing of d drug. This is known as Microdosing Studies.
Exception to phase 1 drugs are anticancer drugs d trials for which are directly done in patients because of unacceptable toxicity.

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