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How many people will be selected for phase II trial?

(a) The whole market will be under surveillance

(b) 300-3000 people

(c) 20-300 people

(d) 20-50 people

This question was posed to me in an interview for job.

Asked question is from Controlled Release Medication in portion Controlled Release Medication of Drug Biotechnology

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The correct answer is (c) 20-300 people

Explanation: Once the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials are performed on larger groups 20-300 and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. Phase 1 trial will be done on 20-50 people. Phase 3 trial will be done on 300-3000 people. Phase 4 trial is post-marketing surveillance.

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