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

posted by Obinoscopy  – USA, 2018-09-12 02:38 (1916 d 04:52 ago) – Posting: # 19264
Views: 4,423

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

UA Flag
Activity
 Admin contact
22,823 posts in 4,786 threads, 1,633 registered users;
32 visitors (0 registered, 32 guests [including 6 identified bots]).
Forum time: 06:30 CET (Europe/Vienna)

In these matters the only certainty is
that nothing is certain.    Pliny the Elder

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5