Comp in-vitro disso studies for generics in India [Dissolution / BCS / IVIVC]

posted by jag009  – NJ, 2020-03-13 17:34 (927 d 05:53 ago) – Posting: # 21268
Views: 2,384

Thank you ping4santosh. Lastly, is there a requirment on what kind of testings need to be done on the reference product (i.e, potenty or total assay, any others)? I know the US rules but not if it's the same as in India.

Thanks
J

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