Intrauterine Device – Levo­nor­gestrel 52 mg [Design Issues]

posted by marianna.macera – Brazil, 2021-06-30 17:04 (583 d 21:45 ago) – Posting: # 22443
Views: 1,147

Dear All,

Could anyone make a suggetion about number of subjects to a Bioequivalence / Bioavailability studie of a intrauterine system contening Levonorgestrel? We are following FDA- "Draft Guidance on Levonorgestrel" and was used CV 35.5%, from a clinical study phase II, it is that possible?

Complete thread:

UA Flag
Activity
 Admin contact
22,478 posts in 4,708 threads, 1,603 registered users;
13 visitors (0 registered, 13 guests [including 12 identified bots]).
Forum time: 13:50 CET (Europe/Vienna)

If you don’t like something change it;
if you can’t change it, change the way you think about it.    Mary Engelbreit

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