Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Back to the forum  2018-07-23 16:58 CEST (UTC+2h)

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

posted by Obinoscopy - Nigeria, 2018-04-22 15:11  - Posting: # 18718
Views: 1,926

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:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,547 posts in 3,941 threads, 1,192 registered users;
online 19 (1 registered, 18 guests [including 11 identified bots]).

[The] impatience with ambiguity can be criticized in the phrase:
absence of evidence is not evidence of absence.    Carl Sagan

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