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© 2016

Validation of Alternative Methods for Toxicity Testing

  • Chantra Eskes
  • Maurice Whelan
Book

Part of the Advances in Experimental Medicine and Biology book series (AEMB, volume 856)

Table of contents

  1. Front Matter
    Pages i-xx
  2. Chantra Eskes, Maurice Whelan
    Pages 1-7
  3. Sonja Beken, Peter Kasper, Jan-Willem van der Laan
    Pages 33-64
  4. Claudius Griesinger, Bertrand Desprez, Sandra Coecke, Warren Casey, Valérie Zuang
    Pages 65-132
  5. Sandra Coecke, Camilla Bernasconi, Gerard Bowe, Ann-Charlotte Bostroem, Julien Burton, Thomas Cole et al.
    Pages 133-163
  6. Grace Patlewicz, Andrew P. Worth, Nicholas Ball
    Pages 165-187
  7. Rodger D. Curren, Albrecht Poth, Hans A. Raabe
    Pages 189-203
  8. Rebecca A. Clewell, Patrick D. McMullen, Yeyejide Adeleye, Paul L. Carmichael, Melvin E. Andersen
    Pages 205-230
  9. Sebastian Hoffmann, Thomas Hartung, Martin Stephens
    Pages 231-241
  10. Raffaella Corvi, Mireia Vilardell, Jiri Aubrecht, Aldert Piersma
    Pages 243-257
  11. Glyn N. Stacey, Sandra Coecke, Anna-Bal Price, Lyn Healy, Paul Jennings, Anja Wilmes et al.
    Pages 259-297
  12. Sofia P. Rebelo, Eva-Maria Dehne, Catarina Brito, Reyk Horland, Paula M. Alves, Uwe Marx
    Pages 299-316
  13. Andrew P. Worth, Grace Patlewicz
    Pages 317-342
  14. João Barroso, Il Young Ahn, Cristiane Caldeira, Paul L. Carmichael, Warren Casey, Sandra Coecke et al.
    Pages 343-386
  15. Back Matter
    Pages 401-407

About this book

Introduction

This book provides information on best practices and new thinking regarding the validation of alternative methods for toxicity testing. It covers the validation of experimental and computational methods and integrated approaches to testing and assessment. Validation strategies are discussed for methods employing the latest technologies such as tissue-on-a-chip systems, stem cells and transcriptomics, and for methods derived from pathway-based concepts in toxicology.

 

Validation of Alternative Methods for Toxicity Testing is divided into two sections, in the first, practical insights are given on the state-of-the-art and on approaches that have resulted in successfully validated and accepted alternative methods. The second section focuses on the evolution of validation principles and practice that are necessary to ensure fit-for-purpose validation that has the greatest impact on international regulatory acceptance of alternative methods. In this context validation needs to keep pace with the considerable scientific advancements being made in toxicology, the availability of sophisticated tools and techniques that can be applied in a variety of ways, and the increasing societal and regulatory demands for better safety assessment.

 

This book will be a useful resource for scientists in the field of toxicology, both from industry and academia, developing new test methods, strategies or techniques, as well as Governmental and regulatory authorities interested in understanding the principles and practicalities of validation of alternative methods for toxicity testing.

 

Keywords

Computational methods Human-on-a-chip In Vitro Toxicity Testing Transcriptomics Validation

Editors and affiliations

  • Chantra Eskes
    • 1
  • Maurice Whelan
    • 2
  1. 1.SeCAM Services & Consultation on Alternative MethodsMagliasoSwitzerland
  2. 2.European Commission Joint Research Centre (JRC)IspraItaly

About the editors

Chantra Eskes, PhD, Eng.

With Engineering and MsC degrees in food sciences followed by a PhD in in vitro neurotoxicity, Dr. Eskes has over 20 years of experience in the development, optimization, validation, peer-review and regulatory acceptance of alternative methods to animal toxicity testing. Her activities have contributed to the formal validation and regulatory acceptance of several test methods and to the development of a number of official international test guidelines.

Dr. Eskes is a Nominated Expert for the Organisation for Economic Co-operation and Development (OECD), the President of the European Society of In Vitro Toxicology (ESTIV), and the Executive Secretary of the Animal Cell Technology Industrial Platform on the production of biopharmaceuticals (ACTIP). She is the founder and manager of SeCAM, a company offering independent consultation and services regarding alternative methods for scientific, regulatory, and industrial requirements. She is also editor, author, and co-author of a number of scientific monographs, articles, and book chapters and acts as reviewer for several journals in the field of in vitro toxicology.

Maurice Whelan

Prof. Maurice Whelan is head of the Systems Toxicology Unit of the Institute for Health and Consumer Protection (IHCP) of the European Commission's Joint Research Centre (JRC), based in Ispra, Italy. He also leads the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) of the JRC, established under EU Directive 2010/63 on the protection of animals used for scientific purposes to build on the 20 years of activities of ECVAM, the European Centre for the Validation of Alternative Methods. His areas of expertise include the development, validation and promotion of alternative approaches to animal testing both for regulatory safety assessment of chemicals (inc. nanomaterials) and for applications in biomedical research. Whelan is the EU co-chair of the OECD Advisory Group on Molecular Screening and Toxicogenomics that is responsible for the OECD programme on Adverse Outcome Pathways, and he is a member of the Steering Committee of the European Partnership for Alternative Approaches to Animal Testing (EPAA). He also currently holds an external appointment of visiting Professor of Bioengineering at the University of Liverpool (UK).

Bibliographic information

  • Book Title Validation of Alternative Methods for Toxicity Testing
  • Editors Chantra Eskes
    Maurice Whelan
  • Series Title Advances in Experimental Medicine and Biology
  • Series Abbreviated Title Adv Exp Med Biol
  • DOI https://doi.org/10.1007/978-3-319-33826-2
  • Copyright Information Springer International Publishing Switzerland 2016
  • Publisher Name Springer, Cham
  • eBook Packages Biomedical and Life Sciences Biomedical and Life Sciences (R0)
  • Hardcover ISBN 978-3-319-33824-8
  • Softcover ISBN 978-3-319-81612-8
  • eBook ISBN 978-3-319-33826-2
  • Series ISSN 0065-2598
  • Series E-ISSN 2214-8019
  • Edition Number 1
  • Number of Pages XX, 407
  • Number of Illustrations 4 b/w illustrations, 40 illustrations in colour
  • Topics Pharmaceutical Sciences/Technology
    Molecular Medicine
  • Buy this book on publisher's site
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