Drug Development 0.0 / 5 ? BiologyMedicine and drugsGCSEAQA Created by: Mr_MackintoastCreated on: 19-03-17 13:16 What are the four stages of drug development? Pre Clinical Development (0-3 years), Clinical Development (4-9 years), Regulatory Review (10-11 years) and Drug Launch (>11 years) 1 of 7 What happens in the pre-clinical development stage? Pre-Clinical- New compounds undergo lab tests. Animal tests are used to investigate effects computers can't predict. 2 of 7 What happens in the Clinical Development Stage [PHASE 1]? Phase 1 (3-4 years)- Tested on 50-100 healthy volunteers to work out dosages 3 of 7 What happens in the Clinical Development Stage [PHASE 2]? Phase 2 (4-5 years)- 200-400 patients are tested to see if it workds and to discover side effects 4 of 7 What happens in the Clinical Development Stage [PHASE 3]? Phase 3 (5-9 Years)- 3000+ patients- some get drug and others get a placebo to test the effectiveness 5 of 7 What happens in the Regulatory Review Stage? Regulatory Review- Data is studied by regulatory authority. If the benefits outway the risks, the drug is licensed as a treatment 6 of 7 What happens in the Drug Launch Stage? Drug Launch- Drug continues to be studied for very rare side effects 7 of 7
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