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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 peopleThis 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

Answer»

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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