Ahem – number of units - ICH M9 [Dissolution / BCS / IVIVC]

posted by Relaxation  – Germany, 2021-10-28 18:20 (697 d 17:37 ago) – Posting: # 22661
Views: 1,803

A nice evening to everybody.

I am slightly sorry for responding in such an old thread, but as actually someone else zombified it, only slightly.

Stumbling over this thread, I only wanted to point to another document probably relevant for discussion of the approaches on f2, risking that this was discussed elsewhere and I just missed it.
This is the not so young ICH M9 "GL on BCS biowaivers" from beginning of 2020, where naturally also comparison of dissolution profiles is mentioned in chapter 3.2.

Unless I missed something there is f2 and only f2 mentioned. No "F2-testing or other suitable tests" mentioned, no open discussion for alternative methods.

I personally would think that bootstrapping may still be discussed as an application of the "f2-approach", but the general feel of this chapter is kind of restrictive too me.

Oh and its not only EMA, as far as I saw recently, ICH M9 replaced the FDA-Waiver guidance.

Best regards!

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