Presentation on S7A - ICH

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Follow-up Studies • Case-by-case • Provide a greater depth of understanding • List provided not comprehensive or prescriptive • In some cases more appropriate to address effects in other non-clinical and/or clinical studies ICH-5 November 10, 2000
Supplemental Studies • Other organ systems not addressed by core battery - Renal/Urinary System - Autonomic Nervous System - Gastrointestinal System 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: Follow-up and Supplemental SP Studi
Page 19 and 20: Timing in Relation to Clinical Deve
Page 21 and 22: Dose Levels In Vivo • Define dose
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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