ICH M13 [BE/BA News]

posted by ElMaestro  – Denmark, 2019-11-27 21:42 (533 d 14:31 ago) – Posting: # 20879
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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

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