Bioequivalence and Bioavailability Forum 11:03 CET

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AB rating & bioequivalence [Regulatives / Guidelines]

posted by mayur661 - India, 2018-11-13 09:33  - Posting: # 19592
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There are some Oral Solution drug product having AB rating as per Orange book. But for these product there is no OGD recommendation is listed. Whether for this product bio-equivalence study need to be required in ANDA submission.

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