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

posted by dshah  – India/United Kingdom, 2022-09-09 19:56 (580 d 18:22 ago) – Posting: # 23290
Views: 2,777

Hi John!

❝ If you fail f2 comparison between highest and lowest (or other) strengths then they wont grant you the waiver unless you run bio, even if you claim formulations are proportional.


You can try multi tablet for dissolution, or perform bootstrap for f2, try model dependent and independent approaches to prove similarity in dissolution.

Regards,
Divyen

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