Neil
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India,
2019-07-25 18:18

Posting: # 20440
Views: 904
 

 Reference Literature [Regulatives / Guidelines]

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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
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Vienna, Austria,
2019-07-26 10:42

@ Neil
Posting: # 20443
Views: 738
 

 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.

Cheers,
Helmut Schütz
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