Bioequivalence and Bioavailability Forum • f2 computation (for pts

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

posted by Obinoscopy – USA, 2018-09-11 22:21 (2445 d 10:40 ago) – Posting: # 19260
Views: 5,845

❝ One question related to f2 computation... According to guidance you only include one pt after 85 % release.

Yes.

❝ 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?

I don't think so. Once 85% dissolution has been achieved, then we can calculate for f2.

Was told 85% is a sacred clinical number (don't ask who told me ;-)

). Was told once 85% of a drug dissolves within the expected time the drug gets to the intestine, then it is very bioavailable. Whatever happens beyond the 85% is just additional info which isn't critical.

Based on this, I think 85% is the determinant. Only if 85% is not achieved then we now check when plateau is reached.

Not sure though. Perhaps I'm mixing up biowaivers dissolution with other form of dissolution studies.

—
Scopy

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