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
Preface
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
This book aims to provide an elementary outline of the toxicological investigations which are required in order for a drug to reach the market place. This ‘child's guide’ is intended primarily as an introduction to the subject, providing an insight into the worldwide regulatory environment of toxicology. As such it should be useful for undergraduates and postgraduates studying for toxicological examinations as well as graduate scientists engaged in the practice of toxicology. It should also be of value to the individuals with an interest in the conduct and assessment of toxicological studies such as clinicians, regulatory affairs, managers of small companies who use contract research facilities, teaching staff and technical advisors inter alia.
We would like to thank Mr David Gask for providing the figures and Mrs Janice Richardson for secretarial assistance. Lastly A.P. is especially grateful to his wife for her forbearance during the production of the book which is dedicated to Andrew and Victoria.
- Type
- Chapter
- Information
- A Practical Approach to Toxicological Investigations , pp. xi - xiiPublisher: Cambridge University PressPrint publication year: 1989