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RegisterBaseline corrected and/ or uncorrected Ursodiol [Regulatives / Guidelines]
Dear forum members,
For Ursodiol capsules FDA recommends:
Bioequivalence based on (90% CI): Baseline corrected and uncorrected (i) unconjugated ursodiol and (ii) total (conjugated and unconjugated) ursodiol.
However we intend to submit to MHRA. Could someone please advise if MHRA also insists on baseline corrected as well as uncorrected data, or only baseline corrected data will be sufficient to show BE.
Thank you,
Kind regards,
CR
For Ursodiol capsules FDA recommends:
Bioequivalence based on (90% CI): Baseline corrected and uncorrected (i) unconjugated ursodiol and (ii) total (conjugated and unconjugated) ursodiol.
However we intend to submit to MHRA. Could someone please advise if MHRA also insists on baseline corrected as well as uncorrected data, or only baseline corrected data will be sufficient to show BE.
Thank you,
Kind regards,
CR
Complete thread:
- Unconjugated and total in BE assessment durenmatt 2010-09-22 17:28 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Baseline corrected and/ or uncorrected Ursodiolcr.maroj 2013-12-19 16:42
- Ursodeoxycholic acid: Unconjugated and total in BE assessment Mauricio Sampaio 2017-04-05 18:52
Ing. Helmut Schütz