biowaiver for higher strength [Regulatives / Guidelines]

posted by dshah  – India/United Kingdom, 2022-01-24 11:01 (123 d 06:30 ago) – Posting: # 22750
Views: 905

Hi John!
Interesting question but when we revisit guidelines, the biowaiver recommendation is mostly for lower strength formulation only. I believe that the criteria of not using higher strength due to safety/AE if justifiable, then may be used to support waiver using lower strength.
Regards,
Dshah

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