Intrauterine Device – Levo­nor­gestrel 52 mg [Design Issues]

posted by marianna.macera – Brazil, 2021-06-30 15:04 (152 d 08:43 ago) – Posting: # 22443
Views: 611

(edited by marianna.macera on 2021-06-30 16:48)

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 We are following FDA- "Draft Guidance on Levonorgestrel" and was used CV 35.5%, from a clinical study phase II, it is that possible?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:

Activity
 Admin contact
21,778 posts in 4,555 threads, 1,547 registered users;
online 11 (0 registered, 11 guests [including 6 identified bots]).
Forum time: Monday 22:47 CET (Europe/Vienna)

Mediocrity knows nothing higher than itself,
but talent instantly recognizes genius.    Arthur Conan Doyle

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