Fed-fasted BE studies using different polymorphs [Regulatives / Guidelines]

posted by qualityassurance – 2023-08-03 12:44 (351 d 11:37 ago) – Posting: # 23692
Views: 1,567

Dear Helmunt,

❝ There are quite nasty examples in the literature of bioinequivalence when the API was changed from microcrystalline to amorphous.

can you provide me such literature if you are having access to those?

Thanks and regards,
QA

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