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

posted by Obinoscopy  – USA, 2018-09-12 00:38 (1427 d 22:23 ago) – Posting: # 19264
Views: 4,007

» 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
22,289 posts in 4,666 threads, 1,585 registered users;
online 2 (0 registered, 2 guests [including 2 identified bots]).
Forum time: Tuesday 23:01 CEST (Europe/Vienna)

The existing scientific concepts cover always only
a very limited part of reality,
and the other part that has not yet
been understood is infinite.    Werner Heisenberg

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