Do your homework first [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-07-26 10:42  – Posting: # 20443
Views: 544

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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