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RegisterEnzalutamide [Design Issues]
Dear all
I need help to understand the dose to be administered for enzalutamide 40mg Capsule BE study.
As per recently published OGD recommendation dose is "Strength: 40 mg at a dose of 160 mg (4x40mg", however reported Cmax for for 160 mg is 3.6 µg/mL.
Can we perform study with single capsule administration for studies to be perform other than USFDA submission, because looking at the reported Cmax it will be possible to measure the concentrations with single capsule (40mg Dose).
Note; As per product lable single daily dose is 160 mg (4x 40mg)
Edit: Category changed and guidance linked. [Helmut]
I need help to understand the dose to be administered for enzalutamide 40mg Capsule BE study.
As per recently published OGD recommendation dose is "Strength: 40 mg at a dose of 160 mg (4x40mg", however reported Cmax for for 160 mg is 3.6 µg/mL.
Can we perform study with single capsule administration for studies to be perform other than USFDA submission, because looking at the reported Cmax it will be possible to measure the concentrations with single capsule (40mg Dose).
Note; As per product lable single daily dose is 160 mg (4x 40mg)
Edit: Category changed and guidance linked. [Helmut]
Complete thread:
- Enzalutamidepash413 2015-12-07 13:22
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Which regulatory agency? Helmut 2015-12-07 17:59
Ing. Helmut Schütz