Bioequivalence and Bioavailability Forum • f2 computation (for pts

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

posted by jag009 – NJ, 2018-09-12 02:00 (2440 d 00:26 ago) – Posting: # 19262
Views: 5,690

❝ ❝ 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?

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❝ 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:

NOT me! My boss said so... I was wondering too.
Does it matter if the drug is an ER or IR?

Thx
John

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