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RegisterUnconjugated and total in BE assessment [Regulatives / Guidelines]
Hello,
First time user, very nice and useful website.
I was wondering if someone might be able to offer advice on the need to present unconjugated and total (unconjugated+conjugated) data for EU submission, for compounds such as ursodeoxycholic acid or naloxone, in BE trials. In the case it is, would the expectation be to be within 80-125% limits for all analytes, or would certain analytes be required for supportive information only? For ursodiol (ursodeoxylic acid), FDA clearly requires demonstration of BE on total and unconjugated drug, but the EMA guidance doesn't address conjugation.
Thanks in advance,
Dürenmatt
First time user, very nice and useful website.
I was wondering if someone might be able to offer advice on the need to present unconjugated and total (unconjugated+conjugated) data for EU submission, for compounds such as ursodeoxycholic acid or naloxone, in BE trials. In the case it is, would the expectation be to be within 80-125% limits for all analytes, or would certain analytes be required for supportive information only? For ursodiol (ursodeoxylic acid), FDA clearly requires demonstration of BE on total and unconjugated drug, but the EMA guidance doesn't address conjugation.
Thanks in advance,
Dürenmatt
Complete thread:
- Unconjugated and total in BE assessmentdurenmatt 2010-09-22 17:28 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Baseline corrected and/ or uncorrected Ursodiol cr.maroj 2013-12-19 16:42
- Ursodeoxycholic acid: Unconjugated and total in BE assessment Mauricio Sampaio 2017-04-05 18:52
Ing. Helmut Schütz