Bioequivalence and Bioavailability Forum

Main page Policy Latest Posts Abbreviations

Profile comparison requirements [Regulatives / Guidelines]

posted by PriyalAayushi – India, 2018-03-13 05:09 (2229 d 05:09 ago) – Posting: # 18524
Views: 2,326

Dear friends,

Is it must to have matching dissolution profile of all 3 registration batches with RLD for ANDA filing purpose?

If 2 batches have F2 50+ but one below 50, then what?

Please help.

Thanks

Complete thread:

Profile comparison requirementsPriyalAayushi 2018-03-13 04:09 [Regulatives / Guidelines]
- Homework Helmut 2018-03-13 13:36
- Profile comparison requirements jag009 2018-03-15 21:45

Admin contact
22,987 posts in 4,824 threads, 1,663 registered users;
81 visitors (0 registered, 81 guests [including 5 identified bots]).
Forum time: 11:19 CEST (Europe/Vienna)

The only way to comprehend what mathematicians mean by Infinity
is to contemplate the extent of human stupidity. Voltaire

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz