mayur661
☆    

India,
2018-11-13 10:33
(1989 d 21:35 ago)

Posting: # 19592
Views: 1,836
 

 AB rating & bioequivalence [Regulatives / Guidelines]

Post reply
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 11:19
(1989 d 20:49 ago)

@ mayur661
Posting: # 19593
Views: 1,550
 

 Forum policy

Post reply
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
 
UA Flag
Activity
 Admin contact
22,993 posts in 4,828 threads, 1,656 registered users;
120 visitors (0 registered, 120 guests [including 3 identified bots]).
Forum time: 09:09 CEST (Europe/Vienna)

Never never never never use Excel.
Not even for calculation of arithmetic means.    Martin Wolfsegger

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5