Bioequivalence and Bioavailability Forum 01:39 CET

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

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

posted by jayashree iyengar - US, 2018-07-05 21:29  - Posting: # 19024
Views: 571

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]

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,154 posts in 4,080 threads, 1,308 registered users;
online 7 (0 registered, 7 guests [including 6 identified bots]).

One can show the following: given any rule, however “fundamental”
or “necessary” for science, there are always circumstances
when it is advisable not only to ignore the rule,
but to adopt its opposite.    Paul Feyerabend

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