Bioequivalence and Bioavailability Forum • Fed-fasted BE studies using different polymorphs

Fed-fasted BE studies using different polymorphs [Regulatives / Guidelines]

posted by qualityassurance – 2023-08-03 12:44 (530 d 16:42 ago) – Posting: # 23692
Views: 2,238

Dear Helmunt,

❝ There are quite nasty examples in the literature of bioinequivalence when the API was changed from microcrystalline to amorphous.

can you provide me such literature if you are having access to those?

Thanks and regards,
QA

Complete thread:

Fed-fasted BE studies using different polymorphs london12 2009-08-25 14:21 [Regulatives / Guidelines]
- Fed-fasted BE studies using different polymorphs Helmut 2009-08-27 00:44
  - Fed-fasted BE studies using different polymorphs Ohlbe 2009-08-31 01:34
    - Submission of 'failed' studies Helmut 2009-08-31 15:36
      - Submission of 'failed' studies Ohlbe 2009-08-31 23:01
  - Fed-fasted BE studies using different polymorphsqualityassurance 2023-08-03 10:44

Admin contact
23,362 posts in 4,906 threads, 1,676 registered users;
121 visitors (0 registered, 121 guests [including 17 identified bots]).
Forum time: 04:27 CET (Europe/Vienna)

I have not failed 700 times. I have not failed once.
I have succeeded in proving
that those 700 ways will not work. Thomas Alva Edison

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz