Regulatory Toxicology
| Körperschaft: | |
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| Weitere Verfasser: | , |
| Zusammenfassung: | 1000 p. 360 illus., 180 illus. in color. text |
| Sprache: | Englisch |
| Veröffentlicht: |
Berlin, Heidelberg :
Springer Berlin Heidelberg : Imprint: Springer,
2020.
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| Schlagworte: | |
| Online-Zugang: | https://doi.org/10.1007/978-3-642-36206-4 |
| Format: | Elektronisch Buch |
Inhaltsangabe:
- 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.