Module 3 Presentations

14/05/2024

Know Your Target Market - 3  Choice of materials and religious/cultural acceptability (e.g. pork products and Muslims)  Look at the competition! o May not be sensible to develop a lyophile in a vial if the competition is a liquid in a pre-filled syringe & autoinjector for patient administration o Large tablets/capsules and/or many per day for the correct dose are not patient friendly  Ignore specific dosage forms for children at your peril

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Data Development

 Candidate Selection  What do you need to know about the molecule besides pharmacology? o Can it be synthesised economically on a commercial scale? Choice of route for purity and yield. o Cell line and product yield? Scalable for market? o Purity and impurities (metals, genotoxic compounds especially) unchanged on scale up? o Stability o Physical Properties for formulation for humans

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