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RegisterIntrauterine Device – Levonorgestrel 52 mg [Design Issues]
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There is Besides " FDA Draft Guidance on Levonorgestrel", We used data from the article: "Comparative pharmacokinetic analysis of levonorgestrel-releasing intrauterine systems and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,
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There is Besides " FDA Draft Guidance on Levonorgestrel", We used data from the article: "Comparative pharmacokinetic analysis of levonorgestrel-releasing intrauterine systems and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,
Complete thread:
- Intrauterine Device – Levonorgestrel 52 mg marianna.macera 2021-06-30 15:04 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Intrauterine Device – Levonorgestrel 52 mg Relaxation 2021-06-30 17:22
- Intrauterine Device – Levonorgestrel 52 mgmarianna.macera 2021-07-02 16:55
- Intrauterine Device – Levonorgestrel 52 mg Helmut 2021-07-02 17:18
- Intrauterine Device – Levonorgestrel 52 mgmarianna.macera 2021-07-02 16:55
- Intrauterine Device – Levonorgestrel 52 mg Relaxation 2021-06-30 17:22
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