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As per FDA guideline for ANDA submission, Clinical trial studies are
required against Innovator.
Type of studies are mentioned as
1) Comparative bioequivalence
2) Comparative Pharmacodynamics
3) Comparative clinical trial/ clinical endpoints
4) Comparative In-vitro test
I would like to know basic difference among Comparative clinical
trial, comparative pharmacodynamics & comparative In-vitro test.
Sr. Executive - Business Development
Corporate Office, New-Delhi (India)
PROMED Exports Pvt. Ltd.
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