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

posted by ping4santosh  – India, 2020-03-14 22:20  – Posting: # 21270
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(edited by ping4santosh on 2020-03-14 22:49)

Hello Jag,

I know the US rules but not if it's the same as in India...

Please let us know the US rules.

Lastly, is there a requirment on what kind of testings...

You need to show the disso profile in different medias with different pH mimicking the various zones of bio absorption. It again depends on the BCS classification of the product and the use of solublizers. It will be helpful if you post your understanding of US rules so that I would know where to guide you.

Cheers,
SKM

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