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

posted by dshah – India, 2020-07-17 04:40 (24 d 06:10 ago) – Posting: # 21729
Views: 1,744

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:

Activity
 Admin contact
20,992 posts in 4,375 threads, 1,460 registered users;
online 11 (1 registered, 10 guests [including 6 identified bots]).
Forum time: Monday 10:50 UTC (Europe/Vienna)

[Those] who have an excessive faith in their theories or in their
ideas are not only poorly disposed to make discoveries, but they
also make very poor observations.    Claude Bernard

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