Bioequivalence and Bioavailability Forum • f2 computation (for pts

f2 computation (for pts > 85%) [Dissolution / BCS / IVIVC]

posted by ElMaestro – Belgium?, 2018-09-10 22:52 (777 d 20:14 ago) – Posting: # 19258
Views: 3,394

Hi jag,

» One question related to f2 computation... According to guidance you only include one pt after 85 % release. But for drugs that don't show plateau after 85% (ie; even at one pt after 85%, the curve is still climbing) you have to include addition points right?

Where does that concept come from? And could you put more words to it?
Also, I am thinking a plateau is something which is hard to debate in a purely measurable way.

Muy confundido :confused:

—
I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

Complete thread:

f2 computation (for pts > 85%) jag009 2018-09-10 18:41 [Dissolution / BCS / IVIVC]
- f2 computation (for pts > 85%)ElMaestro 2018-09-10 22:52
  - f2 computation (for pts > 85%) jag009 2018-09-12 00:00
- f2 computation (for pts > 85%) Obinoscopy 2018-09-11 20:21
  - f2 computation (for pts > 85%) jag009 2018-09-12 00:01
    - f2 computation (for pts > 85%) - WHO GL Obinoscopy 2018-09-12 00:38
      - f2 computation (for pts > 85%) - WHO GL Helmut 2018-09-12 01:01
      - f2 computation (for pts > 85%) - WHO GL jag009 2018-09-12 20:35
        
        f2 computation (for pts > 85%) - WHO GL ElMaestro 2018-09-12 22:02