Bioequivalence and Bioavailability Forum 23:10 CET

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Profile comparison requirements [Regulatives / Guidelines]

posted by PriyalAayushi - India, 2018-03-13 04:09  - Posting: # 18524
Views: 1,069

Dear friends,

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

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

Please help.

Thanks

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