regulatory reasons to consider the study inadequate [Study As­sess­ment]

posted by Astea – Russia, 2019-03-02 18:02 (882 d 09:17 ago) – Posting: # 19987
Views: 4,962

Dear Friends!

In the appendix of The Guideline on the Investigation on Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1) there is a Table 3.2 Additional pharmacokinetic data for <analyte> in <study ID>, where it is supposed to put information about the records where Cmax is the first point (as well as records where AUC0-t/AUC0-∞<0.8 and records where pre-dose sample > 5% Cmax). Could the regulators ban the results of the BE study with such data? Did you ever faced with this in your practice? What was the percentage of subjects with such data (for example for 0.8 it is common to suppose more than 20%)? If there is only one or two subjects with Cmax in the first point should we perform additional analysis excluding them in order to show that this doesn't affect the results if it was not stated in the protocol?


Edit: Appendix IV linked. [Helmut]

"Being in minority, even a minority of one, did not make you mad"

Complete thread:

Activity
 Admin contact
21,596 posts in 4,516 threads, 1,532 registered users;
online 3 (0 registered, 3 guests [including 3 identified bots]).
Forum time: Sunday 04:20 CEST (Europe/Vienna)

Sit down before fact as a little child,
be prepared to give up every conceived notion,
follow humbly wherever and whatever abysses nature leads,
or you will learn nothing.    Thomas Henry Huxley

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