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Biomarkers in Risk Assessment - Validity and Validation (Paperback)
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Biomarkers in Risk Assessment - Validity and Validation (Paperback)
Series: Environmental Health Criteria, No. 222
Expected to ship within 10 - 15 working days
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This publication seeks to provide a framework for selecting and
validating biomarkers for risk assessment. Initial chapters
consider the role of biomarkers in risk assessment and their
validity. A biomarker is any substance, structure or process that
can be measured in the body or its products, and influence or
predict the incidence of outcome or disease. Biomarkers can be
classified into markers of exposure, effect and susceptibility. If
biomarkers are to contribute to environmental and occupational
health risk assessments, they have to be relevant and valid.
Relevance refers to the appropriateness of biomarkers to provide
information on questions of interest and importance to public and
environmental health authorities and other decision-makers. The
validity of a biomarker is a function of intrinsic qualities of the
biomarker and characteristics of the analytic procedures.
Additionally, three broad categories of validity can be
distinguished: measurement validity, internal study validity and
external validity. Measurement validity is the degree to which a
biomarker indicates what it purports to indicate. Internal study
validity is the degree to which inferences drawn from a study
actually pertain to study subjects and are true. External validity
is the extent to which findings of a study can be generalized to
apply to other populations. Subsequent chapters examine the
validation of specific types of biomarkers and cross-species
comparability. Supporting the main text are four extensive
appendices covering the following subjects: 1. Biomarkers of
exposure and effect for carcinogenicity 2. Biomarkers of exposure
and effect for non-carcinogenic end-points 3. Measurement of drug
metabolizing enzyme polymorphisms as indicators of susceptibility
4. Validation of biomarkers for environmental health research and
risk assessment
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