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

posted by jag009  – NJ, 2020-03-12 15:41 (839 d 01:33 ago) – Posting: # 21259
Views: 4,397

Hi everyone,

I have question relating to ANDA in India (CDSCO). With US ANDA, we have the FDA recommended dissolution method for a marketed drug which the generic company needs to carry out the Test vs Ref in-vitro with (if the method is not doable for some reason then the company must justify they have to use another meothod). Does this exist in India? If not then, what's the approach for India ANDA (I mean aside from developing your own method for your product and compare against the ref).

Reference article link, if available, would be greatly appreciated.

Thx
J

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