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RegisterFDA: Biowaiver on lower strengths [Regulatives / Guidelines]
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
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
Cheers,
Osama
Complete thread:
- FDA: Biowaiver on lower strengths jag009 2018-05-24 03:26 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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
Ing. Helmut Schütz