Neil
☆    

India,
2019-07-25 18:18
(588 d 11:14 ago)

Posting: # 20440
Views: 1,625
 

 Reference Literature [Regulatives / Guidelines]

Thread locked
when [email protected] not have Rld label guidelines for a drug, which one should be referred? Its USFDA submission


Edit: See this post #3 and follow the Forum’s Policy[Helmut]
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2019-07-26 10:42
(587 d 18:51 ago)

@ Neil
Posting: # 20443
Views: 1,348
 

 Do your homework first

 
Hi Neil,

do you see Guidelines on top of the page?

What about the overarching “Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA”? If in doubt, initiate a Controlled Correspondence. Otherwise, you risk an R-t-R.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Activity
 Admin contact
21,366 posts in 4,462 threads, 1,493 registered users;
online 4 (0 registered, 4 guests [including 2 identified bots]).
Forum time: Friday 04:33 CET (Europe/Vienna)

The statistician has no magic touch by which
he may come in at the stage of tabulation
and make something of nothing.    W. Edwards Deming

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