Question

A drug which was developed and released into the market for general public use is found...

A drug which was developed and released into the market for general public use is found to have long term adverse effects and has been withdrawn from the market after 3 years of its use. This part of the removal comes under which phase of clinical trials?

A. Phase V

B.  Phase IV

C. Phase III

D. Phase II

E. Phase I

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Answer #1

The correct answer is Option (b) Phase 4

Withdrawal of drugs after marketing for general public use comes under Phase 4 of clinical trial. Even the another name of Phase 4 is Post marketing surveillance phase. Phase 4 studies and tests for the long term adverse effects of drugs after marketing.

The options, Phase 1,phase 2,phase 3 are incorrect as they all come in premarketing period.

Phase 5 is also a post marketing clinical trial, but if refers to long term post marketing surveillance. But here the correct option is phase 4 as the duration of drug withdrawal comes nearly 3 years.

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