Bioequivalence and Bioavailability Forum

Main page Policy Latest Posts Abbreviations

FDA: Biowaiver on lower strengths [Regulatives / Guidelines]

posted by wienui – Germany/Oman, 2018-05-24 17:25 (2491 d 07:39 ago) – Posting: # 18813
Views: 2,772

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

Admin contact
23,409 posts in 4,921 threads, 1,671 registered users;
17 visitors (0 registered, 17 guests [including 9 identified bots]).
Forum time: 00:05 CET (Europe/Vienna)

There are no such things as applied sciences,
only applications of science. Louis Pasteur

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz