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Chemical-specific Adjustment Factors for Interspecies Differences and Human Variability: Guidance Document for Use of Data in ... No. 2 (Harmonization Project Documents)
 
 
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Chemical-specific Adjustment Factors for Interspecies Differences and Human Variability: Guidance Document for Use of Data in ... No. 2 (Harmonization Project Documents) [Paperback]

World Health Organization (Author)

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Book Description

Harmonization Project Documents December 2005
The objective of this document is to provide guidance to risk assessors on the use of quantitative toxicokinetic and toxicodynamic data to address interspecies and interindividual differences in dose/concentration-response assessment. Section 1 focuses on the relevance of this guidance in the context of the broader risk assessment paradigm and other initiatives of the International Program on Chemical Safety (IPCS) project on the Harmonization of Approaches to the Assessment of Risk from Exposure to Chemicals. Technical background material is presented in section 2, followed by generic guidance for the development of chemical-specific adjustment factors in section 3 and accompanying summary figures. Illustrative case-studies are included in an Appendix and a glossary of terms is also provided.


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Inside This Book (learn more)
First Sentence:
The objective of this document is to provide guidance to risk assessors on the use of quantitative toxicokinetic and toxicodynamic data to address interspecies and interindividual differences in dose/concentration-response assessment. Read the first page
Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
active chemical moiety, toxicodynamic data, appropriate toxicokinetic parameter, acetic acid metabolite, default uncertainty factor, active acid metabolite, composite uncertainty factor, critical toxic effect, inhibited indicate, active chemical entity, interspecies factor, toxicokinetic data, human variability, parent chemical, testicular toxicity, following oral exposure, plasma haemoglobin, haematological effects, interspecies differences, susceptible subgroups, default factor, appropriate study design, alcohol metabolite, microsomal protein, internal dose
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