FDA: Biowaiver on lower strengths [Regulatives / Guidelines]

posted by wienui  – Germany/Oman, 2018-05-24 15:25 (1463 d 05:12 ago) – Posting: # 18813
Views: 1,978

Hi John,

I'm afraid yes. As the lower test strength have to pass the in vitro comparative dissolution testing vs the high bio-batch (which pass the BE study vs the RLD) test strength.
regards,
Osama

Cheers,
Osama

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