AB rating & bioequivalence [Regulatives / Guidelines]

posted by mayur661 – India, 2018-11-13 10:33 (2354 d 06:26 ago) – 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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