2024-04-30 06:33
(22 d 13:56 ago)

Posting: # 23966
Views: 340

 Orlistat 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.

UA Flag
 Admin contact
23,035 posts in 4,835 threads, 1,643 registered users;
21 visitors (0 registered, 21 guests [including 7 identified bots]).
Forum time: 20:30 CEST (Europe/Vienna)

Satisfaction of one’s curiosity is one of the greatest sources
of happiness in life.    Linus Pauling

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz