One fail and one success, should it be accepted? [Regulatives / Guidelines]

posted by WhiteCoatWriter – India, 2019-07-23 14:18 (637 d 23:26 ago) – Posting: # 20438
Views: 1,632

Hi
ssussu,

Most of us come across such situations where we have a study that has not been bio equivalent because of one subject and after all the investigations there has been no reason to exclude the subject and thereby accept the fate of the study and repeat the study with the same formulation. However, in your case, if the formulation batch remains the same, I guess you can proceed with the ANDA application while you must however be ready with a strong justification for why you chose a fully replicated design and describe in detail about it (from what I assume is a case of a highly variable drug).

Thanks and Regards
Dr Anonymous
(WhiteCoatWriter)

Complete thread:

Activity
 Admin contact
21,419 posts in 4,475 threads, 1,510 registered users;
online 20 (0 registered, 20 guests [including 5 identified bots]).
Forum time: Wednesday 13:44 CEST (Europe/Vienna)

In the Middles Ages the lingua franca of science was Latin.
Nowadays the language of science is bad English.    Anonymous

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