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

posted by ping4santosh  – India, 2020-03-12 19:18  – Posting: # 21260
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Hi jag009,

AFAIK, it's upto the company to develop the disso profile and submit the data with acceptable range of F values.

If I have time over weekend, I will try to find references.

Cheers,
SKM

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