Bioequivalence and Bioavailability Forum 03:39 CEST

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

BE waiver for proportional formula [Regulatives / Guidelines]

posted by Luongnv - Vietnam, 2018-02-22 07:35  - Posting: # 18443
Views: 1,417

Hi all,

I tried to look for similar discussion but none found.

We are developing a formula (let's say, 40mg) and intend to waiver the BE for 20mg dosage form. The two formulae are proportional. However, the innovator 40mg and 20mg formulae are different in terms of inactives.

Dissolution of respective formula is similar with f2>85.

Is it acceptable if we apply BE waiver for the low dose?

Please pass your comments.

Thanks and regards

Luong (Mr.)

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,698 posts in 3,983 threads, 1,236 registered users;
online 8 (0 registered, 8 guests [including 7 identified bots]).

When puzzled, it never hurts to read the primary documents –
a rather simple and self-evident principle that has, nonetheless,
completely disappeared from large sectors
of the American experience.    Stephen Jay Gould

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