Log in
RegisterOrlistat PD Endpoint BE study [Regulatives / Guidelines]
Dear All,
As per the USFDA recommendation, if we conduct the Orlistat PD Endpoint BE study, we may have data (fecal fat) for Baseline, Test, Ref1 and Ref2
Can anyone explain how to analyze the pharmacodynamic study data step by step? how to establish dose response relationship?. Any example dataset are available?
Kindly suggest, which software (WinNonlin/SAS/etc…) is required to analyze these data.
Regards
NK
As per the USFDA recommendation, if we conduct the Orlistat PD Endpoint BE study, we may have data (fecal fat) for Baseline, Test, Ref1 and Ref2
Can anyone explain how to analyze the pharmacodynamic study data step by step? how to establish dose response relationship?. Any example dataset are available?
Kindly suggest, which software (WinNonlin/SAS/etc…) is required to analyze these data.
Regards
NK
Complete thread:
- Orlistat PD Endpoint BE studyNK 2024-04-30 04:33 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
Ing. Helmut Schütz