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How many people will be selected for phase III 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 at a job interview.I want to ask this question from Controlled Release Medication in chapter Controlled Release Medication of Drug Biotechnology

Answer»

Right option is (b) 300-3000 people

To ELABORATE: Phase III studies are controlled tests on large PATIENT groups 300–3,000 or more depending upon the disease and are aimed at being ASSESSMENT of how EFFECTIVE the drug is, in comparison with current treatment method. Phase 1 trial will be done on 20-50 people. Phase 2 trial will be done on 20-300 people. Phase 4 trial is post-marketing surveillance.



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