ICH pushed by GBHI? [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2019-11-28 12:37 (252 d 07:29 ago) – Posting: # 20883
Views: 2,323

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

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

Complete thread:

 Admin contact
20,969 posts in 4,374 threads, 1,460 registered users;
online 26 (2 registered, 24 guests [including 10 identified bots]).
Forum time: Thursday 21:07 CEST (Europe/Vienna)

It is a good morning exercise for a research scientist
to discard a pet hypothesis every day before breakfast.
It keeps him young.    Konrad Lorenz

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