Module 3 Presentations

14/05/2024

Phase II and Phase III Studies

 Bigger quantities of drug needed  Phase II

o Begin to develop commercial route o Detailed characterisation of impurities o Consider reserve route (just in case) o Optimisation and scale up studies run concurrently

 Phase III studies best done with commercial route (and scale if possible) drug substance

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For the Market

 Larger quantities of drug substance and drug product needed so should have: o A product that will sell (not over priced!) o Established controlled and audited supply chain for all components and all markets o Well understood and well controlled processes o Reproducible product from batch to batch with known stability characteristics

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