ICH M13 [BE/BA News]

posted by ElMaestro  – Belgium?, 2019-11-27 21:42 (306 d 01:57 ago) – Posting: # 20879
Views: 2,797

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?

I could be wrong, but...

Best regards,
ElMaestro

R's base package has 274 reserved words and operators, along with 1761 functions. I can use 18 of them (about 14 of them properly). I believe this makes me the Donald Trump of programming.

Complete thread:

Activity
 Admin contact
21,084 posts in 4,398 threads, 1,468 registered users;
online 2 (0 registered, 2 guests [including 1 identified bots]).
Forum time: Tuesday 00:39 CEST (Europe/Vienna)

To know the history of science is to recognize the mortality
of any claim to universal truth.    Evelyn Fox Keller

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