AB rating & bioequivalence [Regulatives / Guidelines]
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.
- AB rating & bioequivalence mayur661 2018-11-13 09:33
- Forum policy Ohlbe 2018-11-13 10:19