Design for the EMA [Regulatives / Guidelines]

posted by ryraman2661 – India, 2023-05-15 15:03 (141 d 05:15 ago) – Posting: # 23554
Views: 937

Dear Members,

I have one point to be discussed in the forum.

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

If yes, whether both Cmax and AUC (total) to be included in the criteria? or we can compare only AUC (total).
What are the others points to be taken care.

Members can give their opinion.



Edit: Subject line changed; see also this post #2. [Helmut]

Complete thread:

UA Flag
 Admin contact
22,771 posts in 4,777 threads, 1,627 registered users;
21 visitors (0 registered, 21 guests [including 12 identified bots]).
Forum time: 20:18 CEST (Europe/Vienna)

The real struggle is not between the right and the left
but between the party of the thoughtful
and the party of the jerks.    Jimmy Wales

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