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RegisterIntrauterine Device – Levonorgestrel 52 mg [Design Issues]
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 We are following FDA- "Draft Guidance on Levonorgestrel" and was used CV 35.5%, from a clinical study phase II, it is that possible?
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 We are following FDA- "Draft Guidance on Levonorgestrel" and was used CV 35.5%, from a clinical study phase II, it is that possible?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:
- Intrauterine Device – Levonorgestrel 52 mgmarianna.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 mg marianna.macera 2021-07-02 16:55
- Intrauterine Device – Levonorgestrel 52 mg Helmut 2021-07-02 17:18
- Intrauterine Device – Levonorgestrel 52 mg marianna.macera 2021-07-02 16:55
- Intrauterine Device – Levonorgestrel 52 mg Relaxation 2021-06-30 17:22
Ing. Helmut Schütz