2020-01-24 08:19
(408 d 16:34 ago)

Posting: # 21085
Views: 1,334

 Bioequivalence Acceptance criteria for in-vitro binding study in EMA submission [Regulatives / Guidelines]

Dear All,

What is the Bioequivalence Acceptance criteria for in-vitro binding study of Colesevelam for EMA submission?
 Admin contact
21,371 posts in 4,463 threads, 1,496 registered users;
online 3 (0 registered, 3 guests [including 1 identified bots]).
Forum time: Monday 00:53 CET (Europe/Vienna)

When puzzled, it never hurts to read the primary documents 
a rather simple and self-evident principle that has, nonetheless,
completely disappeared from large sectors
of the American experience.    Stephen Jay Gould

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