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
5 - Measurements and observations made in living animals
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
During the pretest phase, after animals have been allocated to treatment groups but before treatment begins, a series of tests and observations are usually undertaken. These are repeated at various intervals during the in-life phase of the study. They are designed to measure a variety of parameters which help to determine the health of the animal, and to indicate whether any adverse effects are being caused and if so, identify the time of their onset. Some of these observations are non-invasive and simple to perform, while others may use invasive techniques (such as regular sampling of body fluids), and require sophisticated and automated analytical equipment. The frequency of such monitoring depends to a large extent on the measurements being made, the nature and duration of the study, and the species under test.
OVERT BEHAVIOUR
Assessment of the behaviour of animals should be carried out ‘informally’ on a daily basis before dosing begins and throughout the study. More formal clinical observations, such as those described below, should be conducted before dosing begins and thereafter at regular intervals throughout the in-life phase. Since these observations form the basis for any treatment related changes in behaviour, they should be recorded in an appropriate log or record sheet, dated and initialled.
Before examining an animal its identification should be verified by reference to its ear marking, tattoo or collar tag. Rodents should be placed on a flat surface and their posture, movements and behaviour observed.
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- Information
- A Practical Approach to Toxicological Investigations , pp. 64 - 86Publisher: Cambridge University PressPrint publication year: 1989