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How many people will be selected for phase I trial?(a) The whole market will be under surveillance(b) 300-3000 people(c) 20-300 people(d) 20-50 peopleThis question was addressed to me in an online interview.My question comes from Controlled Release Medication in portion Controlled Release Medication of Drug Biotechnology

Answer»

Right choice is (d) 20-50 people

For explanation: Phase I trials are the first stage of testing in human subjects. Normally, a small GROUP of 20-50 healthy VOLUNTEERS will be selected. This phase includes trials designed to assess the SAFETY (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. Phase 2 trial will be DONE on 20-300 people. Phase 3 trial will be done on 300-3000 people.



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