Do your homework first [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-07-26 10:42 (548 d 15:54 ago) – Posting: # 20443
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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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