US (or EU) ANDA: Fail f2 but pass BE? [Regulatives / Guidelines]

posted by dshah  – India/United Kingdom, 2022-09-20 18:02 (671 d 11:13 ago) – Posting: # 23309
Views: 2,959

Dear Rayhope:
The decision tree is from article: In Vitro Dissolution Profiles Similarity Assessment in Support of Drug Product Quality: What, How, When—Workshop Summary Report.
Regards,
Divyen

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