Trend analysis as per recent USFDA guideline [Bioanalytics]

posted by dshah  – India/United Kingdom, 2020-08-01 07:32 (786 d 16:07 ago) – Posting: # 21815
Views: 4,782

Dear All!

If we consider the recent FDA guideline or ICH M10, i believe trend analysis for IS response, CC and QCs is also required. FDA does ask if there is upward or downward trend observed. The important point for SOP of CRO should be - allowed limit for IS response. If this not limited for that 3 subjects, then i believe CRO's practice and SOP needs to be revised.

Regards,
Dshah


Edit: Guidelines linked. [Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
22,390 posts in 4,685 threads, 1,594 registered users;
online 4 (0 registered, 4 guests [including 4 identified bots]).
Forum time: Monday 23:39 CEST (Europe/Vienna)

The purpose of models is not to fit the data,
but to sharpen the questions.    Samuel Karlin

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