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RegisterABE / RSABE [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2013-01-03 13:27 (4923 d 05:20 ago) – Posting: # 9782
Views: 3,603
Hi APB!
So you are expecting a CVintra >30% in the fed (?) study and want to go for RSABE. I don’t see any reason why the FDA should not accept such an approach. A warning: If you don’t have strong evidence that you deal with a HVD/HVDP (i.e., CVintra < ~40%) power the study for conventional ABE. If by chance the CV is <30% you are not allowed to scale. For details see FDA’s progesterone guidance.
❝ […] the study […] seems to be on the basis of ISCV in two different meal status. One study is planned to be two way and one as three way. In three way study, the reference will be dosed twice and the test once.
So you are expecting a CVintra >30% in the fed (?) study and want to go for RSABE. I don’t see any reason why the FDA should not accept such an approach. A warning: If you don’t have strong evidence that you deal with a HVD/HVDP (i.e., CVintra < ~40%) power the study for conventional ABE. If by chance the CV is <30% you are not allowed to scale. For details see FDA’s progesterone guidance.
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Study design ABP 2013-01-01 18:06
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- More details, please Helmut 2013-01-01 18:31
- More details, please ABP 2013-01-03 11:44
- ABE / RSABEHelmut 2013-01-03 12:27
- ABE / RSABE ABP 2013-01-09 08:01
- ABE / RSABEHelmut 2013-01-03 12:27
- More details, please ABP 2013-01-03 11:44
- More details, please Helmut 2013-01-01 18:31
Ing. Helmut Schütz