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Regulatory Toxicology

  • Reference work
  • © 2021

Overview

Editors:
  1. Franz-Xaver Reichl

    1. Department of Operative/Restorative Dentistry, Periodontology and Pedodontics, University Hospital, LMU, München, Germany

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    You can also search for this editor in PubMed   Google Scholar

  2. Michael Schwenk

    1. Formerly: Hannover Medical School, Hannover, Germany

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    You can also search for this editor in PubMed   Google Scholar

  • Serves as a unique reference guide for governments worldwide
  • Provides unique insight into toxicological risk assessment
  • Describes modern test systems, explains basic risk concepts, and discusses dogmas in different regulation areas

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Table of contents (99 entries)

  1. Front Matter

    Pages i-xxix
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  2. The “Modus Operandi” of Regulatory Toxicology

    1. Front Matter

      Pages 1-1
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    2. Aims and Mission of Regulatory Toxicology

      • Helmut Greim
      Pages 3-22

    3. Working Areas of Regulatory Toxicology

      • Michael Schwenk, H. Paul A. Illing
      Pages 23-33

    4. National and International Collaboration in Regulatory Toxicology

      • Alfonso Lampen, Klaus E. Appel
      Pages 35-50

    5. The Regulatory Process in Toxicology

      • Dietrich Henschler, Wolfgang Dekant
      Pages 51-58

    6. Quality Assurance in Toxicology

      • Klaus-Michael Wollin, Stephen Harston, Werner Lilienblum
      Pages 59-67

    7. Toxicological Risk Assessment

      • Maged Younes, Nikolaos Georgiadis
      Pages 69-79

  3. Tests and Methods

    1. Front Matter

      Pages 81-81
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    2. Monoclonal Antibodies: Discovery and Protein Engineering

      • Wibke Lembke, Mathias Locher
      Pages 83-98

    3. Characterization of Physicochemical Parameters in Toxicology

      • Mathias Locher
      Pages 99-106

    4. Examination of Acute and Repeated-Dose Toxicity

      • Volker Mostert, Karl Georg Heimann, Kevin Doughty
      Pages 107-115

    5. Examination of Organ Toxicity

      • Wolfgang Kaufmann, Matt C. Jacobsen
      Pages 117-127

    6. Specific Toxicity Tests for Neurotoxicity, Immunotoxicity, Allergy, Irritation, Reprotoxicity, and Carcinogenicity

      • Eckhard von Keutz
      Pages 129-138

    7. Toxicity Testing In Vitro: Regulatory Aspects

      • Eckhard von Keutz
      Pages 139-148

    8. Integration of Advanced Technologies into Regulatory Toxicology

      • Horst Spielmann, Helena Kandarova
      Pages 149-161

    9. Computer-Based Prediction Models in Regulatory Toxicology

      • Thomas Steger-Hartmann, Scott Boyer
      Pages 163-175

    10. Metabolism Investigations in Drug Development

      • Jens Riedel, Alain Krick
      Pages 177-187

    11. Toxicokinetic Tests

      • Jürgen Pauluhn
      Pages 189-213

    12. Toxicodynamic Tests

      • Alexander Cartus, Dieter Schrenk
      Pages 215-229
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Keywords

About this book



This 2nd edition of the Handbook "Regulatory Toxicology" was written and updated by experts for professionals, scientists and all those involved in toxicological data generation and decision-making. It includes a number of new chapters that cover recent developments, such as regulation of nanoparticles, illicit designer drugs or tattoos.

The Handbook deals comprehensively with the safety-ensuring methods and concepts employed for acute and chronic toxicity by regulatory agencies, industry and academics.


Editors and Affiliations

  • Department of Operative/Restorative Dentistry, Periodontology and Pedodontics, University Hospital, LMU, München, Germany

    Franz-Xaver Reichl

  • Formerly: Hannover Medical School, Hannover, Germany

    Michael Schwenk

About the editors

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.


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