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

posted by ping4santosh  – India, 2020-03-15 10:05 (198 d 01:13 ago) – Posting: # 21276
Views: 1,528

Hi J,

» In terms of disso, for US you have to follow the FDA recommended dissolution method listed for the designated reference product. If there is no FDA method then you use the USP method.

Selection of a disso method, the way you perform in industries depend on many factors - -

As you say If its USA, it should meet USP; japan - JP; india - IP etc..... If you want to sell in a country, prove that your product meets their pharmacopoeial limits

Whether an established method for dissolution testing of Drug or its product is available in pharmacopoeia or not? If yes, go on as per their procedure

If no, go for any other good pharmacopoeial test already set for a particular product.
else You can go for your own in-house methods...

Also there will be some other reasons why certain industries do in-house tests specifically. Even in that case, they show that their product meets the limits.

Hope it helps!
Cheers,
SKM


Edit: Standard quotes restored; see also this post #8. [Ohlbe]

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