Presentation on S7A - ICH

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S7A Panel Discussion Dr. J. DeGeorge: Dose Selection Dr. J. Moe: Metabolites, Isomers And Finished Products Dr. K. Fujimori: Good Laboratory Practice Dr. K. Olejniczak: Future Activities : S7B QT/Torsade ICH-5 November 10, 2000
Dose Levels In Vivo • Define dose-response • Include and exceed primary PD or therapeutic range • Absent adverse effect on SP parameter, use dose producing moderate adverse effects in this or in other (toxicology) studies of similar route and duration ICH-5 November 10, 2000
Page 1 and 2: GUIDELINE ON SAFETY PHARMACOLOGY ST
Page 3 and 4: Table of Content 1. INTRODUCTION 1.
Page 5 and 6: Definition of SP • Studies that i
Page 7 and 8: General SP Principles • Rational
Page 9 and 10: Route(s) of Administration • Clin
Page 11 and 12: Safety Pharmacology Core Battery
Page 13 and 14: Safety Pharmacology Core Battery (c
Page 15 and 16: Follow-up and Supplemental SP Studi
Page 17 and 18: Supplemental Studies • Other orga
Page 19: Timing in Relation to Clinical Deve
Page 23 and 24: Isomers and Finished Products • C
Page 25 and 26: Non-GLP GLP Implementation of GLP I
Page 27 and 28: S7B Non-clinical Approaches for Pre

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