Regulatory Toxicology

ISBN-13: 9783030574987 / Angielski / Twarda / 2021 / 1558 str.

Franz-Xaver Reichl; Michael Schwenk

Spis treści

Aims and Mission of Regulatory Toxicology Working Areas of Regulatory Toxicology National and International Collaboration in Regulatory Toxicology The Regulatory Process in Toxicology Quality Assurance in Toxicology Toxicological Risk Assessment Monoclonal Antibodies – Discovery and Protein Engineering Characterization of Physicochemical Parameters in Toxicology Examination of Acute and Repeated-Dose Toxicity Examination of Organ Toxicity Specific Toxicity Tests for Neurotoxicity, Immunotoxicity, Allergy, Irritation, Reprotoxicity, and Carcinogenicity Toxicity Testing In Vitro. Regulatory Aspects Integration of Advanced Technologies into Regulatory Toxicology Computer-Based Prediction Models in Regulatory Toxicology Metabolism Tests in Regulatory Toxicology Toxicokinetic Tests Toxicodynamic Tests Omics in Toxicology Epidemiological Methods in Regulatory Toxicology Early Clinical Trials Statistical Evaluation Methods in Toxicology Dose-Response Analysis, Identification of Threshold Levels for Chemicals Extrapolation-Procedures for Carcinogenic and Noncarcinogenic Compounds Probabilistic Methods in Toxicology Exposure Analysis for Indoor Contaminants Benchmark Dose Approach in Regulatory Toxicology Human Biomonitoring: Its Importance in Toxicological Regulation Toxicodynamic Models Toxicokinetic Models Exposure Scenarios in Toxicology Quality Criteria for Primary Literature in Toxicology Data-Mining in Toxicology Principles of Analytical Chemistry for Toxicology Uncertainty Analysis in Exposure Assessment-Relevance for Toxicological Risk Assessment Read-Across Methodology in Toxicological Risk Assessment Green and Sustainable Chemistry as Regulatory Levers Do Carcinogens Have a Threshold Dose? The Pros and Cons Single Substances Versus Combined Effects: Problems in Mixture Toxicology Biomolecules Versus Smaller Chemicals in Toxicology: ICH, EU, and US Recommendations Sensitive Humans Versus Average Persons in Toxicology Default Factors in Quantitative Risk Assessment Assessment of Background Exposure and Additional Exposure by Human Biomonitoring Adverse Effects Versus Non-adverse Effects in Toxicology Health-Based Threshold Values Versus MOS in Toxicology Precaution Principle Versus Danger Prevention in Toxicology Hygienic Versus Toxicological Approaches in Regulation Protected Property and Protection Level in Regulatory Toxicology Ethical Issues in Science. Focus on Regulatory Toxicology Teaching Chemical Safety Current Role of the Risk Concept in Regulatory Toxicology Importance of Physicochemical and Physical Properties for Toxicological Risk Assessment Intrinsic Toxicity of Substances - Aspects for Risk Assessment Importance of Xenobiotic Metabolism –Mechanistic Considerations Relevant for Regulation Dose–Response Relationship and Extrapolation in Toxicology. Mechanistic and Statistical Considerations Importance of Exposure Level for Toxicological Risk Assessment Risk Characterization in Regulatory Toxicology Risk Evaluation in Regulatory Toxicology Risk Comparison in Toxicology Risk-Benefit Considerations in Toxicology Toxicological Risk Assessment in Different Jurisdictions International Regulation of Toxicological Test Procedures Risk Cycles in Toxicology Risk Minimization in Drug Development. Regulatory Aspects Purpose and Methods of Risk Management in Regulatory Toxicology Assessment of Limit Values in Regulatory Toxicology Limit Value Setting in Different Regulatory Areas of Toxicology Registration and Approval in Regulatory Toxicology Health Hazard Classification and Labelling Restrictions and Prohibitions as Tools in Regulatory Toxicology Susceptible Population Groups in Regulatory Toxicology Toxicology Report Risk Management in Toxicological Disasters Institutionalized Participation in Regulatory Toxicology Risk Communication: Challenges for Toxicologists and Other Risk Experts Dealing with Diseases That Have Been Attributed to Chemical Exposures REACH and CLP. Its Role in Regulatory Toxicology Assessment of Mixtures: Bridging Principles and Other Approaches Notification of Hazardous Mixtures and Cosmetic Products for Poisons Centres in the European Union Chemical and Biological Weapons and Their Regulation Nanoparticles and their Regulation Psychoactive Designer Drugs: Classes, Mechanisms, Regulation Tobacco and Alternative Nicotine Products and Their Regulation Regulation of Dental Materials Microplastics - a Novel Suite of Environmental Contaminants but Present for Decades Regulation of Textiles Regulation and Mitigation of Greenhouse Gases Regulation of Agrochemicals Biopharmaceuticals: CMC Development "Points to Consider" from a Regulatory Perspective Medical Aspects of Traffic Exhaust Regulations Tattooing: Toxicology and Risk Assessment Risk Assessment of Food Additives Risk Assessment of Food Components with Botanical Origin Risk Assessment of Genetically Modified Food and Feed Novel and Traditional Foods: Novel Food Regulation in the EU Microbiome Product Toxicology: Regulatory View on Translational Challenges Toxicological Aspects in the Regulation of Gene Therapy Medicinal Products Defence of Biocidal Active Substance Dossiers in the Context of Regulatory Toxicology Checklist: Toxicological Risk Assessment in Practice Limit Values and Guideline Values in Regulatory Toxicology

O autorze

Franz-Xaver Reichl studied microbiology and medicine in Munich, Germany. He then qualified as a toxicologist/ pharmacologist and works at the Ludwig Maximilians University of Munich (LMU) as a dental-toxicologist at the Dental Clinic and at the Walther-Straub-Institute of Pharmacology and Toxicology at the LMU. His research is mainly related to molecular, cellular, and analytical (dental) toxicology and toxicity. F.X. Reichl consulted health agencies in toxicological risk management and is member of toxicological/pharmacological committees. He is head of the “International Advisory Board for the Biocompatibility/Toxicology of Dental Materials” at the LMU and is “Officer for Biosafety of Bacteria and Viruses” at the LMU Munich.

Michael Schwenk studied biochemistry and medicine in Tübingen, Germany, and thereafter specialized in pharmacology, toxicology, and nutritional and environmental medicine. He was appointed professor in Pharmacology and Toxicology in 1987. He worked in xix universities, basic research institutions, pharmaceutical industry, and a state health agency. 

He created and headed the Regulatory Toxicology Study Group of the German Society of Toxicology, consulted health agencies in toxicological risk management, and was secretary of the IUPAC Division Chemistry and Human Health. 

His research areas include membrane transport of xenobiotics, drug-biomolecule interactions, drug metabolism, cytotoxicity, phase I clinical studies, human biomonitoring, and risk assessment.