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

posted by dshah  – India, 2020-07-17 08:40 (1812 d 05:54 ago) – Posting: # 21729
Views: 11,087

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
23,425 posts in 4,928 threads, 1,683 registered users;
39 visitors (0 registered, 39 guests [including 11 identified bots]).
Forum time: 14:34 CEST (Europe/Vienna)

You can do one of two things; just shut up,
which is something I don’t find easy,
or learn an awful lot very fast,
which is what I tried to do.    Jane Fonda

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