Module 3 Presentations

14/05/2024

Ignore Polymorphism at Your Peril - 2!  The solution: o Much work and money spent o New interim soft gel formulation (refrigerated storage for bulks, not patients) to keep Form II in solution o New filings made January 1999 o Approved in US June 1999 and EU November 1999  Tablets (room temperature storage) not approved until 2009 (EU) or 2010 (USA)

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Conclusions  CMC is not the poor relation in medicines development and cannot be left to last  CMC data needs change constantly throughout development and during product life cycle  In the long term well understood and reproducible quality is the best protection against product quality failure or supply issues in the market But it is not infallible

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