Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-12-13 08:26 CET (UTC+1h)
 

Unconjugated and total in BE assessment [Regulatives / Guidelines]

posted by durenmatt - 2010-09-22 17:28  - Posting: # 5931
Views: 3,008

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

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum | Admin contact
17,556 Posts in 3,758 Threads, 1,091 registered users;
30 users online (0 registered, 30 guests).

The purpose of models is not to fit the data,
but to sharpen the questions.    Samuel Karlin

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed