Intrauterine Device – Levo­nor­gestrel 52 mg [Design Issues]

posted by marianna.macera – Brazil, 2021-06-30 17:04 (1017 d 00:10 ago) – Posting: # 22443
Views: 1,750

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 We are following FDA- "Draft Guidance on Levonorgestrel" and was used CV 35.5%, from a clinical study phase II, it is that possible?

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