ICH pushed by GBHI? [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2019-11-28 12:37 (454 d 15:04 ago) – Posting: # 20883
Views: 3,210

Hi ElMaestro,

» thank you.

Should go to Susana Almeida who notified me. :thumb up:

» 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.

Agree – the major obstacle will be the legal stuff.

» 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.

My impression: ICH-members felt the pressure coming from the GBHI-conferences (Mar 2015 Amsterdam, Sep 2016 Rockville, Apr 2018 Amsterdam).
Biowaivers and IR were topics of the the first two.Let’s wait what will happen in the next conference (12–13 Dec Bethesda).

» 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?

No idea.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

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

Complete thread:

Activity
 Admin contact
21,355 posts in 4,458 threads, 1,493 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Thursday 03:41 CET (Europe/Vienna)

The rise of biometry in this 20th century,
like that of geometry in the 3rd century before Christ,
seems to mark out one of the great ages or critical periods
in the advance of the human understanding.    R.A. Fisher

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