Females in Bio­equi­va­lence studies [Regulatives / Guidelines]

posted by Loky do – Egypt, 2022-03-08 16:36 (836 d 02:26 ago) – Posting: # 22825
Views: 1,703

Dears

Are there any specific requirements regarding studies submitted in European countries for inclusion of females in bioequivalence studies, ex. recommended ratio between males and females, contraception recommendations, ..etc.?

Thanks in advance

Complete thread:

UA Flag
Activity
 Admin contact
23,059 posts in 4,841 threads, 1,664 registered users;
38 visitors (0 registered, 38 guests [including 4 identified bots]).
Forum time: 20:02 CEST (Europe/Vienna)

[…] an inappropriate study design is incapable of answering
a research question, no matter how careful the subsequent
methodology, conduct, analysis, and interpretation:
Flawless execution of a flawed design achieves nothing worthwhile.    J. Rick Turner

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