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FDA: Biowaiver on lower strengths [Regulatives / Guidelines]

posted by wienui – Germany/Oman, 2018-05-24 17:25 (1769 d 15:56 ago) – Posting: # 18813
Views: 2,056

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

Complete thread:

FDA: Biowaiver on lower strengths jag009 2018-05-24 03:26 [Regulatives / Guidelines]
- FDA: Biowaiver on lower strengthswienui 2018-05-24 15:25
- FDA: Biowaiver on lower strengths Yura 2018-05-25 10:22
  - FDA: Biowaiver on lower strengths Yura 2018-05-26 17:21

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