Intrauterine Device – Levo­nor­gestrel 52 mg [Design Issues]

posted by marianna.macera – Brazil, 2021-07-02 16:55 (109 d 06:51 ago) – Posting: # 22453
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Dear Relaxation,

I appreciated your answer, thank you.
There is Besides " FDA Draft Guidance on Levonorgestrel", We used data from the article: "Comparative pharmacokinetic analysis of levonorgestrel-releasing intrauterine systems and levonorgestrel-containing contraceptives with oral or subdermal administration route" Hofmann et. al, 2020.
But the point still the number of subjects in this BE/BA study, because in this case, parallel design needs an intra+inter CV%. But in a scientific literature review, we don't find something like that. A suggestion about mitigating the error in subject number determination?

Best regards,

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