Are Statistical Analysis Plans “required” for Pivotal Studies? [General Sta­tis­tics]

posted by Achievwin – US, 2023-02-15 13:07 (431 d 03:24 ago) – Posting: # 23467
Views: 1,786

❝ Dear colleagues, we are conducting a pivotal fed-fasted BE study versus a reference listed drug (RLD).


Here is my opinion:

Essentially it is your study and you have to defend the submission, it is your prerogative to have what you want. - CRO gets most of their money when they deliver draft report (study pass/fail)

If it is a complex study - you have to predefine critical steps in the SAP (before the sample analysis start- to avoid any claims of Bias).

If it is a study against the product specific guidance and logical analysis is easy to understand you can refer to the FDA guidance(s) in the protocol.

Complete thread:

UA Flag
Activity
 Admin contact
22,988 posts in 4,825 threads, 1,649 registered users;
33 visitors (0 registered, 33 guests [including 10 identified bots]).
Forum time: 17:32 CEST (Europe/Vienna)

As soon as we abandon our own reason, and are content
to rely upon authority, there is no end to our troubles.    Bertrand Russell

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