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

posted by Biostats – India, 2020-01-24 08:19 (199 d 00:57 ago) – Posting: # 21085
Views: 1,075

Dear All,

What is the Bioequivalence Acceptance criteria for in-vitro binding study of Colesevelam for EMA submission?

Complete thread:

Activity
 Admin contact
20,991 posts in 4,375 threads, 1,460 registered users;
online 28 (1 registered, 27 guests [including 17 identified bots]).
Forum time: Monday 10:16 CEST (Europe/Vienna)

[Those] who have an excessive faith in their theories or in their
ideas are not only poorly disposed to make discoveries, but they
also make very poor observations.    Claude Bernard

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