Orlistat PD Endpoint BE study [Regulatives / Guidelines]

posted by NK – India, 2024-04-30 06:33 (20 d 23:23 ago) – Posting: # 23966
Views: 324

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

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