A Practical Approach to Toxicological Investigations

Alan Poole; George B. Leslie

doi:10.1017/CBO9780511753121

First published in 1989, this book acknowledges that new drugs, food additives and other compounds need to be carefully screened for toxic side-effects. The bulk of this study is devoted to the practical questions of 'what toxicological studies should we perform?' and 'how should we perform them?' Compounds which undergo toxicity testing may be conveniently categorised as those which are intended for administration to man and those which are not. The former include pharmaceuticals to be used medicinally or prophylactically and chemicals which are added to our food, drinks or medicine to improve their stability, appearance or palatability. Since it is on pharmaceuticals that the most comprehensive toxicological evaluations are generally performed, this book has been directed primarily towards to toxicological evaluation of potential new drugs. The principles and methodology of toxicological evaluation of other types of compounds are essentially similar.

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Contents

Frontmatter
pp i-iv
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Contents
pp v-viii
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Foreword
pp ix-x
- By Francis J. C. Roe, Wimbledon Common
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Preface
pp xi-xii
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List of abbreviations
pp xiii-xiv
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1 - Introduction
pp 1-9
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2 - Regulatory requirements
pp 10-29
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3 - Animals: sources, selection, husbandry
pp 30-43
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4 - Standard studies in animals
pp 44-63
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5 - Measurements and observations made in living animals
pp 64-86
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6 - Terminal studies
pp 87-100
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7 - Specialised routes of exposure
pp 101-117
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8 - Reproductive toxicology
pp 118-135
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9 - Genotoxicity
pp 136-156
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Appendix 1 - Toxicology data requirements for clinical trial approval and registration of new drugs
pp 157-180
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Appendix 2 - Countries and addresses of regulatory agencies
pp 181-182
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Index
pp 183-188
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A Practical Approach to Toxicological Investigations

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Contents

Frontmatter
pp i-iv

Contents
pp v-viii

Foreword
pp ix-x

Preface
pp xi-xii

List of abbreviations
pp xiii-xiv

1 - Introduction
pp 1-9

2 - Regulatory requirements
pp 10-29

3 - Animals: sources, selection, husbandry
pp 30-43

4 - Standard studies in animals
pp 44-63

5 - Measurements and observations made in living animals
pp 64-86

6 - Terminal studies
pp 87-100

7 - Specialised routes of exposure
pp 101-117

8 - Reproductive toxicology
pp 118-135

9 - Genotoxicity
pp 136-156

Appendix 1 - Toxicology data requirements for clinical trial approval and registration of new drugs
pp 157-180

Appendix 2 - Countries and addresses of regulatory agencies
pp 181-182

Index
pp 183-188

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A Practical Approach to Toxicological Investigations

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