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Search results with tag "Nonclinical overview"
M 4 S Common Technical Document for the Registration of ...
www.ema.europa.euThe Nonclinical Overview should contain appropriate reference citations to the Tabulated Summaries, in the following format: (Table X.X, Study/Report Number). Content and Structural Format The Nonclinical Overview should be presented in the following sequence: Overview of the nonclinical testing strategy Pharmacology Pharmacokinetics
MODULE 2.4 NONCLINICAL OVERVIEW
www.pmda.go.jpCONFIDENTIAL m2.4. Nonclinical Overview 2012N153960_00 7 1. OVERVIEW OF THE NONCLINICAL TESTING STRATEGY 1.1. Introduction Dolutegravir is a novel, potent and selective orally bioavailable integrase inhibitor.