Bioequivalence and Bioavailability Forum

Hi ElMaestro,

❝ thank you.

Should go to Susana Almeida who notified me. 

❝ 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.

• The ICH’s concept paper on biowaivers was published in Oct 2016 and the draft in Oct 2018.
  
• Sumfink about IR BE was overdue.

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.