Major aim of phase 1 clinical trials is to know the:
Ans. (C) Maximum tolerable dose(Ref: KDT 8th/90)Phase I trial is designed as a dose-escalation study to determine the maximum tolerable dosage (MTD), that is, the maximum dose associated with an acceptable level of dose-limiting toxicity.Phase I Clinical Trials:The drug is tested in healthy human volunteers (extremes of ages; elderly and children are excluded).As the drug is not tested in the patients, so we cannot determine efficacy in this phase.This is mainly for finding the maximum tolerable dose of the drug.This is first in human study.The idea of testing the new drug in normal humans is based on the fact that healthy persons are more likely to tolerate the adverse effects of the drug than diseased persons. Because anticancer drugs can produce unacceptable toxicity and we cannot expose healthy humans to such a toxicity, the phase-I trials for anticancer drugs are done in the patientsMajor aim of Phase I clinical trials are to know Maximum tolerable dose > Dose > Pharmacokinetics > Safety.
Safety
Efficacy
Maximum tolerable dose
Pharmacokinetics
General Pharmacology