NK
☆    

India,
2024-04-30 06:33
(442 d 03:53 ago)

Posting: # 23966
Views: 1,979
 

 Orlistat PD Endpoint BE study [Regulatives / Guidelines]

Post reply
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
 
UA Flag
Activity
 Admin contact
23,436 posts in 4,932 threads, 1,674 registered users;
75 visitors (0 registered, 75 guests [including 15 identified bots]).
Forum time: 10:27 CEST (Europe/Vienna)

You are rewarding a teacher poorly
if you remain always a pupil.    Friedrich Nietzsche

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5