Book contents
- Frontmatter
- Contents
- Foreword
- Preface
- List of abbreviations
- 1 Introduction
- 2 Regulatory requirements
- 3 Animals: sources, selection, husbandry
- 4 Standard studies in animals
- 5 Measurements and observations made in living animals
- 6 Terminal studies
- 7 Specialised routes of exposure
- 8 Reproductive toxicology
- 9 Genotoxicity
- Appendix 1 Toxicology data requirements for clinical trial approval and registration of new drugs
- Appendix 2 Countries and addresses of regulatory agencies
- Index
Appendix 2 - Countries and addresses of regulatory agencies
Published online by Cambridge University Press: 04 August 2010
- Frontmatter
- Contents
- Foreword
- Preface
- List of abbreviations
- 1 Introduction
- 2 Regulatory requirements
- 3 Animals: sources, selection, husbandry
- 4 Standard studies in animals
- 5 Measurements and observations made in living animals
- 6 Terminal studies
- 7 Specialised routes of exposure
- 8 Reproductive toxicology
- 9 Genotoxicity
- Appendix 1 Toxicology data requirements for clinical trial approval and registration of new drugs
- Appendix 2 Countries and addresses of regulatory agencies
- Index
Summary
Australia: Commonwealth Department of Community Services and Health, PO Box 100, Woden ACT, 2606 Australia.
Canada Health and Welfare Canada Tunney's Pasture, Ottawa, Ontario, Canada K1A OL2.
EEC: Directorate-General for Internal Market and Industrial Affairs, Rue de la Loi 200, B-1049 Brussels, Belgium.
Japan: Pharmaceutical Affairs Bureau, Ministry of Health and Welfare, 1-2-2 Kasumigaseki Chiyoda-Ku, 100-5 Tokyo.
Nordic: Denmark: Sundhedsstyrelsens Farmaceutiske Laboratorium, Frederiskssundsvej 378, DK-2700 Bronshoj, Denmark.
Finland: Laakintohallitus/Medicinalstyrelsen, Apteekkitoimisto/ Apoteksbyran Siltasaarenkatu 18 a, PL 224, SF-00531 Helsinki 53, Finland.
Iceland: Heilbrigidis-og Trygginamalaraduneytid, Lyfjanefund Laugavegur 116, 15-105 Reykjavik, Iceland.
Norway: Stabens legemiddelkontroll, Sven Oftendals vei 6, N-0950 Oslo, Norway.
Sweden: Socialsytrelsen Lakemedelsavdelning, Box 607, S-751 25 Uppsala, Sweden.
UK: Department of Health and Social Security, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.
USA: Food and Drug Administration, Rockville, MD 20857, USA.
- Type
- Chapter
- Information
- A Practical Approach to Toxicological Investigations , pp. 181 - 182Publisher: Cambridge University PressPrint publication year: 1989