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Which of the trial phase is for pharmacovigilance?(a) Phase I(b) Phase II(c) Phase III(d) Phase IVThis question was posed to me by my school teacher while I was bunking the class.This key question is from Controlled Release Medication topic in section Controlled Release Medication of Drug Biotechnology

Answer»

The correct choice is (d) Phase IV

Easiest explanation: Phase IV trial is also known as Post Marketing Surveillance Trial. Phase IV trials involve safety surveillance (pharmacovigilance) and ongoing technical SUPPORT of a drug after it RECEIVES permission to be sold. Phase 1 consists of research WORK on a group of 20-50 people. Phase 2 and 3 has a group of 20-300 and 300 to 3000 respectively.



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