Validation of Alternative Methods for Toxicity Testing

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.

Chantra Eskes, PhD, Eng.

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

Dr. Eskes is a Nominated Expert for the Organisationfor Economic Co-operation and Development (OECD), the President of the EuropeanSociety of In Vitro Toxicology (ESTIV), and the ExecutiveSecretary of the Animal Cell Technology Industrial Platform onthe production of biopharmaceuticals (ACTIP). She is the founder and manager of SeCAM, a company offeringindependent consultation and services regarding alternative methods forscientific, regulatory, and industrial requirements. She is also editor, author, and co-author of a number of scientific monographs, articles, and bookchapters and acts as reviewer for several journals in the field of in vitro toxicology.

Maurice Whelan

Prof. Maurice Whelan is head of the Systems ToxicologyUnit of the Institute for Health and Consumer Protection (IHCP) of the EuropeanCommission's Joint Research Centre (JRC), based in Ispra, Italy. He also leadsthe European Union Reference Laboratory for Alternatives to Animal Testing(EURL ECVAM) of the JRC, established under EU Directive 2010/63 on theprotection of animals used for scientific purposes to build on the 20 years ofactivities of ECVAM, the European Centre for the Validation of AlternativeMethods. His areas of expertise include the development, validation andpromotion of alternative approaches to animal testing both for regulatory safetyassessment of chemicals (inc. nanomaterials) and for applications in biomedicalresearch. Whelan is the EU co-chair of the OECD Advisory Group on MolecularScreening and Toxicogenomics that is responsible for the OECD programme onAdverse Outcome Pathways, and he is a member of the Steering Committee of theEuropean Partnership for Alternative Approaches to Animal Testing (EPAA). He also?currently holds an externalappointment of visiting Professor of Bioengineering at the University ofLiverpool (UK).