Ursodeoxycholic acid: Unconjugated and total in BE assessment [Regulatives / Guidelines]
Dear members,
according the question above (7 years ago), I am asking to myself and you if anybody to have a response on the need to present unconjugated and total (unconjugated + conjugated) data for ursodeoxycholic acid, to prove the bioequivalence between two formulation (FDA requires demonstration of BE on total and unconjugated drug)?
If the focus of the bioequivalence test is identify significant differences from formulation, what is the sense to quantify tauroursodeoxycholic acid and glycoursodeoxycholic acid ? The measurement of these metabolites in human plasma may be helpful in understanding the metabolism of the parent compound, but it is not applied to understand the differences between two formulation. Both are from physiological limitation and not from galenic limitation.
The quantification only Ursodiol acid (the parent compound unconjugated) is not enough?
If any members could answer me, I really appreciate.
according the question above (7 years ago), I am asking to myself and you if anybody to have a response on the need to present unconjugated and total (unconjugated + conjugated) data for ursodeoxycholic acid, to prove the bioequivalence between two formulation (FDA requires demonstration of BE on total and unconjugated drug)?
If the focus of the bioequivalence test is identify significant differences from formulation, what is the sense to quantify tauroursodeoxycholic acid and glycoursodeoxycholic acid ? The measurement of these metabolites in human plasma may be helpful in understanding the metabolism of the parent compound, but it is not applied to understand the differences between two formulation. Both are from physiological limitation and not from galenic limitation.
The quantification only Ursodiol acid (the parent compound unconjugated) is not enough?
If any members could answer me, I really appreciate.
Complete thread:
- Unconjugated and total in BE assessment durenmatt 2010-09-22 17:28 [Regulatives / Guidelines]
- Baseline corrected and/ or uncorrected Ursodiol cr.maroj 2013-12-19 16:42
- Ursodeoxycholic acid: Unconjugated and total in BE assessmentMauricio Sampaio 2017-04-05 18:52