Significant difference in Cmax of Reference drug product [Study As­sess­ment]

posted by Mehul Patel – India, 2021-08-17 14:02 (531 d 19:01 ago) – Posting: # 22522
Views: 1,530

❝ I guess you had also the same batch of the test? Was the AUC different as well?


Both the tests were different but Reference were same. AUC of Reference was similar for both the studies, only Cmax varied by 22%. What may be the reasons for this?

❝ ❝ […] Can 6 months old (frozen) samples yield significant different results as compared to freshly analyzed study samples?


❝ If long term storage was validated for this duration, no.


Ok. Thanks


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
22,477 posts in 4,708 threads, 1,603 registered users;
21 visitors (0 registered, 21 guests [including 7 identified bots]).
Forum time: 08:04 CET (Europe/Vienna)

The mediocre teacher tells.
The good teacher explains.
The superior teacher demonstrates.
The great teacher inspires.    William Arthur Ward

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