f2 Calculation For Rapidly Dissolving FPPs [Dissolution / BCS / IVIVC]

posted by Obinoscopy  – Nigeria, 2018-04-22 15:11  – Posting: # 18718
Views: 4,433

Dear All,

Even though I have not come across this scenario in practice, I am imagining a situation where a test product is rapidly dissolving (>85% in 30 mins) while the comparator product is very rapidly dissolving (>85% in 15 mins) and vice versa. Is f2 calculation necessary? If it is, which time points will be used?

I am aware, the requirements are different for different NRAs (USFDA, EMEA, WHO, etc). I will appreciate if these are taken into account when answering this question.

Regards,

Scopy

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,265 posts in 4,098 threads, 1,314 registered users;
online 11 (1 registered, 10 guests [including 8 identified bots]).

Competence, like truth, beauty and contact lenses,
is in the eye of the beholder.    Laurence J. Peter

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5