Validation of Alternative Methods for Toxicity Testing

ISBN-13: 9783319816128 / Angielski / Miękka / 2018 / 407 str.

Chantra Eskes; Maurice Whelan

Spis treści

Introduction.- Validation in support of internationally harmonised OECD Test Guidelines for assessing the safety of chemicals.- Regulatory acceptance of alternative methods in the development and approval of pharmaceuticals.- Validation of alternative in vitro methods to animal testing: concepts, challenges, processes and tools.- Practical aspects of designing and conducting validation studies involving multi-study trials.- Validation of computational methods.- Implementation of New Test Methods into Practical Testing.- Pathway Based Toxicology and Fit-for-Purpose Assays.- Evidence-based toxicology.- Validation of transcriptomics-based in vitro methods.- Ensuring the quality of stem cell-derived in vitro models for toxicity testing.- Validation of bioreactor and human-on-a-chip devices for chemical safety assessment.- Integrated approaches to testing and assessment.- International harmonization and cooperation in the validation of alternative methods.- Evolving the principles and practice of validation for new alternative approaches to toxicity testing.      ​

O autorze

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).