ICH M13 [BE/BA News]

posted by ElMaestro  – Denmark, 2019-11-27 22:42 (1582 d 17:52 ago) – Posting: # 20879
Views: 5,806

Hi Hötzi,

thank you.
It will be interesting to see if they will then harmonize the definition of BE. That little subtle difference between EMA's and FDA's definition makes all the difference between allowing PD to be part of a BE proof, or whether that should rather be called TE with all it entails in relation to the discussion of 10.3's, 10.1/10.2's , 505(b)(2)'s, 505(j)'s and so forth.

I am looking forward to seeing how it pans out.

Elegantly, if this is only about IR SODFs then I guess in all (?) cases PK is the go-to method, so possibly they can avoid discussing the definition altogether. Are there any IR SODF's where it could become tricky? Some of the locally acting anti-diarrheal drugs perhaps or the corticosteroids for Crohn's or Colitis Ulcerosa?

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,638 registered users;
73 visitors (0 registered, 73 guests [including 8 identified bots]).
Forum time: 16:34 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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