2019-07-25 18:18
(379 d 19:33 ago)

Posting: # 20440
Views: 1,392

 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]
Vienna, Austria,
2019-07-26 10:42
(379 d 03:09 ago)

@ Neil
Posting: # 20443
Views: 1,152

 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

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