Bioequivalence and Bioavailability Forum • f2 computation (for pts > 85%)

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

posted by Obinoscopy – USA, 2018-09-12 02:38 (1846 d 05:07 ago) – Posting: # 19264
Views: 4,362

❝ Thanks but the person who told me insisted that it is the correct way :confused:

I just checked the WHO interchangeability guideline, it states:

"a maximum of one-time point should be considered after 85% dissolution of the reference (comparator) product has been reached; in the case where 85% dissolution cannot be reached...the dissolution should be conducted until an asymptote (plateau) has been reached"

I don't know what the USFDA GLs say though.

I guess person who told you has a lot of explaining to do. I for one, am very interested in his explanation.

Regards,

—
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 GLObinoscopy 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