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jayashree iyengar
Junior

US,
2018-07-05 21:29

Posting: # 19024
Views: 365
 

 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]
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