Log in
RegisterEmesis in Steady state BE studies [Design Issues]
According to the FDA Guidance for Industry Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations,
‘In the case of modified-release products, the data from subjects who experience emesis any time during the labeled dosing interval can be deleted.’
Kind regards,
Tina
‘In the case of modified-release products, the data from subjects who experience emesis any time during the labeled dosing interval can be deleted.’
Kind regards,
Tina
Complete thread:
- Emesis in Steady state BE studies dk 2014-03-20 11:44 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Emesis in Steady state BE studiesTina 2014-03-20 15:34
- Emesis in Steady state BE studies krish 2014-03-21 05:07
- Emesis in Steady state BE studies dk 2014-03-21 05:37
- Emesis in Steady state BE studies dk 2014-03-21 05:31
- Emesis in Steady state BE studies krish 2014-03-21 05:07
- Emesis in Steady state BE studiesTina 2014-03-20 15:34
Ing. Helmut Schütz