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

posted by jayashree iyengar – US, 2018-07-05 21:29 (1079 d 08:26 ago) – Posting: # 19024
Views: 1,098

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?


Edit: Category changed; see also this post #1[Helmut]

Complete thread:

 Admin contact
21,529 posts in 4,499 threads, 1,523 registered users;
online 3 (0 registered, 3 guests [including 2 identified bots]).
Forum time: Saturday 05:55 CEST (Europe/Vienna)

Anyone who has never made a mistake
has never tried anything new.    Albert Einstein

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz