Module 3 Presentations

14/05/2024

Formulation Considerations  Excipient compatibility (chemical) o Change of polymorphic form on compression?  Dosage form: oral, parenteral, topical? o Simple tablet or sustained release? o Injection, infusion or concentrate?  Stability  Who will manufacture commercial batches? o In-house or contractor? o What do they need to know? o Location? 19

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Preclinical Studies  Need for drug substance (and a delivery system!)  ‘Relatively Dirty Batches’ needed to qualify impurity levels (ICH norms)  Can require lots of drug especially for long term studies so stability data needed  Long term studies (6m toxicity & carcinogenicity) ideally done on commercial route drug substance (should avoid surprise impurities late on)

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