SAP vs. part of the clinical protocol [General Sta­tis­tics]

posted by Sereng  – USA, 2023-02-11 00:34 (832 d 19:19 ago) – Posting: # 23454
Views: 3,801

Hi Helmut, I am not sure whether my reply should be at the top or bottom in this forum. Many thanks for your response. Do you include your BA/BE study SAP with you NDA? Regards

❝ […] whatever format is used (SAP or planned statistics as part of the clinical protocol) it must be detailed enough to enable assessors/inspectors to unambiguously reproduce results with given data.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]
—
Biostatistically Challenged CEO

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,681 registered users;
60 visitors (0 registered, 60 guests [including 36 identified bots]).
Forum time: 20:53 CEST (Europe/Vienna)

Pharmacokinetics may be simply defined as
what the body does to the drug,
as opposed to pharmacodynamics, which may be defined as
what the drug does to the body.    Leslie Z. Benet

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