model-based BE? [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2022-12-10 11:13 (489 d 00:55 ago) – Posting: # 23397
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Hi Mittyri,

❝ FDA encourages generic and new drug applicants to propose and discuss novel methodologies (e.g., model-based BE…)


❝ are you reading this as a projection of VBE or some broader successful trends exist?


Perhaps. See this post refering to the EMA’s Methodology Working Party. Aren’t these points contradictory?

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