BE for the EMA [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2023-05-15 15:40 (137 d 13:21 ago) – Posting: # 23556
Views: 767

Hi Raman,

❝ For Bioequivalence studies for EU submission, can we compare capsules VS tablets of same drug, and same strength.

Yes (see the applicable guideline about ‘pharmaceutical alternatives’).

❝ If yes, whether both Cmax and AUC (total) to be included in the criteria?

What do you mean by ‘AUC (total)’? You need to demonstrate BE for Cmax and AUC0-tlast (alternatively AUC0-72).

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
 Admin contact
22,763 posts in 4,775 threads, 1,627 registered users;
22 visitors (0 registered, 22 guests [including 9 identified bots]).
Forum time: 05:01 CEST (Europe/Vienna)

We should not speak so that it is possible
for the audience to understand us,
but so that it is impossible
for them to misunderstand us.    Quintilian

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