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Back to the forum  2018-06-22 07:34 CEST (UTC+2h)

Homework [Regulatives / Guidelines]

posted by Helmut Homepage - Vienna, Austria, 2018-03-13 13:36  - Posting: # 18529
Views: 589

Hi Priyal,

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

Please do your homework first (see also this post #3).
Hint: In vivo equivalence always overrules in vitro similarity.

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

What do you think?

Cheers,
Helmut Schütz
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