Reanalysis for PK Reason: Gone with the Wind [Bioanalytics]

posted by dshah  – India/United Kingdom, 2020-07-17 08:40 (1340 d 20:35 ago) – Posting: # 21729
Views: 5,081

Greetings team!

I believe that Helmut is correct and without a predefined SOP for repeat analysis, repeat would not be acceptable!

If we are focusing on root cause, I believe that for pre-dose concentration even in period-I would not cause a significant issue to final BE out come as it may only impact AUC and it would not be significant. :-D If the value is MT 5% of Cmax, the subject would by default not considered for statistical evaluation :-). And for Root cause- most of CRO are not able to identify and thus there would not be a CAPA. :confused:


Thanks,
Dshah


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! [Ohlbe]

Complete thread:

UA Flag
Activity
 Admin contact
22,940 posts in 4,812 threads, 1,639 registered users;
39 visitors (0 registered, 39 guests [including 7 identified bots]).
Forum time: 04:15 CET (Europe/Vienna)

Those people who think they know everything
are a great annoyance to those of us who do.    Isaac Asimov

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