AB rating & bioequivalence [Regulatives / Guidelines]

posted by mayur661 – India, 2018-11-13 09:33 (682 d 18:55 ago) – Posting: # 19592
Views: 1,352

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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