Phase I trial is done to test:
Ans. D. PharmacokineticsPhase I trial is also called First in human trial. In this phase, 10-100 healthy people are enrolled to calculate pharmacokinetic data. Phase 0 trials are also done sometimes prior to phase I studies to calculate early pharmacokinetic data. Phase II and III trials usually enrol patients. Phase II trials enrol 50-100 and usually determine drug efficacy and dose ranging. Phase III trials confirm the efficacy in larger population (100-1000). Phase IV trials are also known as postmarketing studies which determine safety (adverse drug reactions, adverse events, and drug-drug interactions). Even safety of long-term drug treatment can be determined in Phase IV trials which can be missed in clinical trials due to limited duration of clinical trials.
Safety
Efficacy
Dose
Pharmacokinetics
General Pharmacology