Ezetimibe BE [Regulatives / Guidelines]

posted by Mutasim – Jordan, 2019-09-23 16:40 (1733 d 22:53 ago) – Posting: # 20641
Views: 5,590

Dear Members,
Would you please advice on interpretation of the requirements for Ezetimibe BE according to the last guidance by EMA, in particular the statement
"Main pharmacokinetic variables: AUC0-72h, Cmax
Background/justification: On total (parent + glucuronide metabolite together)
Does it mean measuring each one alone? or the total as in FDA guidance? and accordingly will the CI be for each one alone or both unconjugated and total or only total?


Edit: Guideline linked. [Helmut]

Complete thread:

UA Flag
Activity
 Admin contact
23,059 posts in 4,841 threads, 1,649 registered users;
37 visitors (0 registered, 37 guests [including 7 identified bots]).
Forum time: 15:33 CEST (Europe/Vienna)

There are only two kinds of scholars;
those who love ideas and those who hate them.    Emile Chartier

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5