Fed-fasted BE studies using different polymorphs [Regulatives / Guidelines]
Dear Helmunt,
Thanks and regards,
QA
❝ There are quite nasty examples in the literature of bioinequivalence when the API was changed from microcrystalline to amorphous.
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
- Submission of 'failed' studies Helmut 2009-08-31 15:36
- Fed-fasted BE studies using different polymorphsqualityassurance 2023-08-03 10:44
- Fed-fasted BE studies using different polymorphs Ohlbe 2009-08-31 01:34
- Fed-fasted BE studies using different polymorphs Helmut 2009-08-27 00:44