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 . ........................................................................................
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This note was uploaded on 01/01/2012 for the course PHAR 6010 taught by Professor Mullis during the Spring '11 term at UGA.

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International Conference on harmonisation of technical requirements for registration of pharmaceutic

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