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Regulatory Toxicology

This book will be written by experts for professionals, scientists and all those involved in toxicological data generation and decision-making. It is the updated and expanded version of a monograph published in German in 2004.  Chemical safety is regulated on various levels including production, sto...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor Corporativo: SpringerLink (Online service)
Otros Autores: Reichl, Franz-Xaver (Editor ), Schwenk, Michael (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Berlin, Heidelberg : Springer Berlin Heidelberg : Imprint: Springer, 2014.
Edición:1st ed. 2014.
Temas:
Acceso en línea:Texto Completo
Tabla de Contenidos:
  • Foreword
  • Introduction
  • Operation mode of regulatory toxicology
  • Aims and institutions
  • Aims and mission
  • Application areas
  • National and international collaboration
  • Procedures and standards
  • The regulatory process
  • Quality assurance in regulatory toxcicology
  • Toxicological risk assessment
  • Methodological repertoire
  • Toxicological tests
  • Characterization of physicochemical parameters
  • Examination of acute and chronic toxicity
  • Examination of organ-toxicity and of laboratory parameters
  • Specific tests for neurotox , immunotox, allergy, irritation, reprotox and carcinogenicity
  • Toxicity testing in vitro
  • New and future toxicological assays
  • Computer-based prediction models
  • Metabolism tests
  • Toxicokinetic tests
  • Toxicodynamic tests
  • Omics
  • International regulation for toxicological test procedures
  • Data acquisition in humans
  • Epidemiological methods
  • Studies in volunteers
  • Chemical analysis in toxicology (New)
  • Toxicostatistics and models
  • Statistical evaluation methods
  • Dose-response analysis, identification of threshold levels
  • Extrapolation-procedures for carcinogenic and non-carcinogenic compounds
  • Probabilistic methods
  • Toxicodynamic models
  • Toxicokinetic models
  • Estimation of exposure
  • Exposure analysis for indoor contaminants
  • Exposure scenarios
  • Use of toxiological data
  • Quality criteria for primary literature
  • Data-mining
  • Paradigms use in risk evaluation
  • Toxicological paradigms
  • Do carcinogens have a threshold dose? pro and contra
  • Single compounds vs combination effects
  • Biomolecules vs smaller chemicals
  • Sensitive humans vs average persons
  • Assessment paradigmas
  • Extrapolation factors and safety factors
  • Background exposure vs additional exposure in human biomonitoring
  • Adverse effects vs non-adverse effects
  • ADI vs MOS principle
  • Precaution principle vs hazard control
  • Hygienic vs toxicological approaches
  • Protected property and protection level
  • Risk characterization and risk evaluation
  • The risk concept
  • Current  role of the term "risk"
  • Risk cycles
  • Risk minimization in drug development
  • Data required for risk evaluation
  • Importance of physical-chemical properties
  • Importance of intrinsic toxic properties
  • Importance of metabolism and of mechanism of action
  • Importance of the extrapolation to lower doses in risk assessment
  • Importance of exposure level for risk assessment
  • Risk characterization
  • Risk assessment
  • Elements of risk assessment
  • Risk comparison
  • Risk-benefit considerations
  • Risk assessment in different jurisdictions
  • Reach as a regulatory instrument (New)
  • Risk management and risk communication
  • Risk management
  • Purpose of risk management
  • Assessment of limit values
  • Deduction of limit values in different areas
  • Registration and approval
  • Classification and labelling
  • Monitoring unwanted exposures and effects
  • Restrictions and prohibitions
  • Observance of susceptible population groups
  • The toxicological expert report
  • Risk management in toxicological emergencies
  • Risk communication and participation of affected people
  • Institutionalized participation
  • The technique of risk communication
  • Dealing with diseases that have been attributed to chemical exposures
  • Addendum: tables and lists
  • Checklist: Toxicological risk assessment in practice
  • Glossary and risk terms
  • Limit values, guideline values, tables
  • Proposed additional chapters on Ethics in toxicology and expansion of the chapter dealing with Immunotoxicology.