mayur661
☆    

India,
2018-11-13 09:33
(942 d 03:01 ago)

Posting: # 19592
Views: 1,429
 

 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.
Ohlbe
★★★

France,
2018-11-13 10:19
(942 d 02:15 ago)

@ mayur661
Posting: # 19593
Views: 1,222
 

 Forum policy

Dear Mayur,

You have already been reminded in the past of the forum policy. Not following it significantly decreases your chances of getting an answer, and may result in your account getting blocked temporarily or permanently.

Regards
Ohlbe
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