International Conference on harmonisation of technical requirements for registration of pharmaceutic

International Conference on harmonisation of technical requirements for registration of pharmaceutic

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INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH H ARMONISED T RIPARTITE G UIDELINE S AFETY P HARMACOLOGY S TUDIES F OR H UMAN P HARMACEUTICALS S7A Recommended for Adoption at Step 4 of the ICH Process on 8 November 2000 by the ICH Steering Committee This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.
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i S AFETY P HARMACOLOGY S TUDIES F OR H UMAN P HARMACEUTICALS ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 8 November 2000, this guideline is recommended for adoption to the three regulatory parties to ICH TABLE OF CONTENTS 1. INTRODUCTION .................................................................................................. 1 1.1 Objectives of the Guideline ............................................................................. 1 1.2 Background ..................................................................................................... 1 1.3 Scope of the Guideline ..................................................................................... 1 1.4 General Principle ............................................................................................ 1 1.5 Definition of Safety Pharmacology ................................................................. 1 2. GUIDELINE ....................................................................................................... 2 2.1 Objectives of Studies ....................................................................................... 2 2.2 General Considerations in Selection and Design of Safety Pharmacology Studies ..................................................................................... 2 2.3 Test Systems .................................................................................................... 3 2.3.1 General Considerations on Test Systems ..................................... 3 2.3.2 Use of In Vivo and In Vitro Studies ............................................... 3 2.3.3 Experimental Design ...................................................................... 3 2.3.3.1 Sample Size and Use of Controls .................................................... 3 2.3.3.2 Route of Administration .................................................................. 3 2.4 Dose Levels or Concentrations of Test Substance ......................................... 4 2.4.1 In Vivo Studies ................................................................................ 4 2.4.2 In Vitro Studies ............................................................................... 4 2.5 Duration of Studies ......................................................................................... 4 2.6 Studies on Metabolites, Isomers and Finished Products .............................. 4 2.7 Safety Pharmacology Core Battery ................................................................ 5 2.7.1 Central Nervous System ................................................................. 5 2.7.2 Cardiovascular System ................................................................... 5 2.7.3 Respiratory System ......................................................................... 5
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Statistical Principles for Clinical Trials ii 2.8 Follow-up and Supplemental Safety Pharmacology Studies ......................... 5 2.8.1 Follow-up Studies for Safety Pharmacology Core Battery ............ 5 2.8.1.1 Central Nervous System .................................................................. 6 2.8.1.2 Cardiovascular System .................................................................... 6 2.8.1.3 Respiratory System .......................................................................... 6 2.8.2 Supplemental Safety Pharmacology Studies ................................. 6 2.8.2.1 Renal/Urinary System ................................................................... 6 2.8.2.2 Autonomic Nervous System ............................................................. 6 2.8.2.3 Gastrointestinal System ................................................................... 6 2.8.2.4 Other Organ Systems ....................................................................... 6 2.9 Conditions under which Studies are not Necessary ...................................... 6 2.10 Timing of Safety Pharmacology Studies in Relation to Clinical Development ..................................................................................................... 7 2.10.1 Studies Prior to First Administration in Humans ......................... 7 2.10.2 Studies During Clinical Development ............................................ 7 2.10.3 Studies Before Approval .................................................................. 7 2.11 Application of Good Laboratory Practice (GLP) ............................................. 7 3. NOTES ................................................................................................................... 8 4. REFERENCES ........................................................................................................ 9
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1 S AFETY P HARMACOLOGY S TUDIES F OR H UMAN P HARMACEUTICALS 1. INTRODUCTION 1.1 Objectives of the Guideline This guideline was developed to help protect clinical trial participants and patients receiving marketed products from potential adverse effects of pharmaceuticals, while avoiding unnecessary use of animals and other resources.
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