Patient population for bioequivalence study [Regulatives / Guidelines]

posted by DavidManteigas – Portugal, 2017-10-06 12:34 (2000 d 22:37 ago) – Posting: # 17866
Views: 3,035

It is hard to provide a valuable opinion without knowing much details, namely whether you're talking about a biosimilar or generic. :-D

Generally, the product-specific guideline states in which condition should be bioequivalence study be performed. For instance, in USA diclofenac is approved for 3 indications but for BE only a study in subjects with osteoarthritis of the knee is required ( If no product-specific guideline exists, I would recommend you to ask for scientific advice on which patient population should be selected for the BE study with clinical endpoint. If I were the Sponsor, I would pick the condition on which the primary endpoint presents less variability in the outcome.

Complete thread:

UA Flag
 Admin contact
22,557 posts in 4,724 threads, 1,608 registered users;
15 visitors (0 registered, 15 guests [including 10 identified bots]).
Forum time: 11:12 CEST (Europe/Vienna)

A scientist’s aim in a discussion with his colleagues
is not to persuade, but to clarify.    Leo Szilard

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