BE for the EMA [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2023-05-15 15:40 (318 d 19:25 ago) – Posting: # 23556
Views: 1,235

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
[image]

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

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
115 visitors (0 registered, 115 guests [including 11 identified bots]).
Forum time: 10:05 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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