Blinded review of PK data: History… [Study Per­for­mance]

posted by kimhuang – China, 2023-10-16 02:43 (132 d 13:28 ago) – Posting: # 23759
Views: 1,336

Dear Helmut,
Thank you very much for your detailed explanation, these stories are very interesting, gaving me a deeper understanding! :-D:-D:-D

❝ ❝ In China, it's common to discuss PK parameters (without treatment assignment, such as pre-dose concentration, abnormal PK concentration profiles, λz estimation, %AUCextrap etc.) to decide analysis set in data review meeting before database lock, is it still compliant with regulatory?

❝ Fine, makes sense scientifically. We did that for decades. But regulations  science. At least for the FDA and EMA a blinded review of PK data is no more allowed – except assessing pre-dose concentrations. We are even allowed to re-analyze those. Schizo­phre­nic, IMHO.


Now, how we can to handle λz estimation (eg, R square <0.8) and %AUCextrap etc (<80%)? Nothing to do, just include all subject in primary analysis? And exclude such subject as sensitivity analysis?
Thank you very much!


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]

Complete thread:

UA Flag
Activity
 Admin contact
22,911 posts in 4,806 threads, 1,635 registered users;
31 visitors (0 registered, 31 guests [including 3 identified bots]).
Forum time: 15:11 CET (Europe/Vienna)

The history of statistics is like a telephone directory:
the plot is boring, full of numbers and the cast is endless.    Stephen Senn

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