jayashree iyengar
☆    

US,
2018-07-05 19:29

Posting: # 19024
Views: 607
 

 BE tables for topical (dental paste)? [Regulatives / Guidelines]

Dear Members:

Please provide your input on:
For Topical (dental paste), waht is/are the BE table Comparative Physicochemical Data required in Module 2.7 of the ANDA submission to further support the waiver request.

Namely, what data table captures for determination that the test formulation is Q1/Q2 same as the RLD?

Thanks.


Edit: Category changed; see also this post #1[Helmut]
Activity
 Thread view
Bioequivalence and Bioavailability Forum |  Admin contact
19,404 posts in 4,122 threads, 1,323 registered users;
online 6 (0 registered, 6 guests [including 4 identified bots]).
Forum time (Europe/Vienna): 16:16 UTC

Those people who think they know everything
are a great annoyance to those of us who do.    Isaac Asimov

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