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Validation of Alternative Methods for Toxicity Testing

Part of the Advances in Experimental Medicine and Biology Book Series (volume 856)

Editors: Eskes, Chantra; Whelan, Maurice

DOI: 10.1007/978-3-319-33826-2

ISBN: 978-3-319-33824-8

Publisher: Springer International Publishing - Springer Journals

Sep 27, 2016

1 - 10 of 15 Chapters

LitStream

Chapter 1Introduction

Eskes, Chantra; Whelan, Maurice

Pages: 1 –7

[Alternative approaches to animal testing are gaining momentum with an increasing number of test methods obtaining international acceptance, thanks in large part to the validation efforts conducted on these assays. The principles and process of validation were first established in the 1990s in...
LitStream

Chapter 2Validation in Support of Internationally Harmonised OECD Test Guidelines for Assessing the Safety of Chemicals

Gourmelon, Anne; Delrue, Nathalie

Pages: 9 –32

[Ten years elapsed since the OECD published the Guidance document on the validation and international regulatory acceptance of test methods for hazard assessment. Much experience has been gained since then in validation centres, in countries and at the OECD on a variety of test methods that were...
LitStream

Chapter 3Regulatory Acceptance of Alternative Methods in the Development and Approval of Pharmaceuticals

Beken, Sonja; Kasper, Peter; van der Laan, Jan-Willem

Pages: 33 –64

[Animal studies may be carried out to support first administration of a new medicinal product to either humans or the target animal species, or before performing clinical trials in even larger populations, or before marketing authorisation, or to control quality during production. Ethical and...
LitStream

Chapter 4Validation of Alternative In Vitro Methods to Animal Testing: Concepts, Challenges, Processes and Tools

Griesinger, Claudius; Desprez, Bertrand; Coecke, Sandra; Casey, Warren; Zuang, Valérie

Pages: 65 –132

[This chapter explores the concepts, processes, tools and challenges relating to the validation of alternative methods for toxicity and safety testing. In general terms, validation is the process of assessing the appropriateness and usefulness of a tool for its intended purpose. Validation is...
LitStream

Chapter 5Practical Aspects of Designing and Conducting Validation Studies Involving Multi-study Trials

Coecke, Sandra; Bernasconi, Camilla; Bowe, Gerard; Bostroem, Ann-Charlotte; Burton, Julien; Cole, Thomas; Fortaner, Salvador; Gouliarmou, Varvara; Gray, Andrew; Griesinger, Claudius; Louhimies, Susanna; Gyves, Emilio Mendoza-de; Joossens, Elisabeth; Prinz, Maurits-Jan; Milcamps, Anne; Parissis, Nicholaos; Wilk-Zasadna, Iwona; Barroso, João; Desprez, Bertrand; Langezaal, Ingrid; Liska, Roman; Morath, Siegfried; Reina, Vittorio; Zorzoli, Chiara; Zuang, Valérie

Pages: 133 –163

[This chapter focuses on practical aspects of conducting prospective in vitro validation studies, and in particular, by laboratories that are members of the European Union Network of Laboratories for the Validation of Alternative Methods (EU-NETVAL) that is coordinated by the EU Reference...
LitStream

Chapter 6Validation of Computational Methods

Patlewicz, Grace; Worth, Andrew P.; Ball, Nicholas

Pages: 165 –187

[In this chapter, we provide an overview of how (Quantitative) Structure Activity Relationships, (Q)SARs, are validated and applied for regulatory purposes. We outline how chemical categories are derived to facilitate endpoint specific read-across using tools such as the OECD QSAR Toolbox and...
LitStream

Chapter 7Implementation of New Test Methods into Practical Testing

Curren, Rodger D.; Poth, Albrecht; Raabe, Hans A.

Pages: 189 –203

[New toxicology test methods, especially those using in vitro methods, are continually being developed. Some are used by industry for screening purposes; others are eventually validated for regulatory use. However, for a new test method to be firmly adopted by industry it must be readily...
LitStream

Chapter 8Pathway Based Toxicology and Fit-for-Purpose Assays

Clewell, Rebecca A.; McMullen, Patrick D.; Adeleye, Yeyejide; Carmichael, Paul L.; Andersen, Melvin E.

Pages: 205 –230

[The field of toxicity testing for non-pharmaceutical chemicals is in flux with multiple initiatives in North America and the EU to move away from animal testing to mode-of-action based in vitro assays. In this arena, there are still obstacles to overcome, such as developing appropriate cellular...
LitStream

Chapter 9Evidence-Based Toxicology

Hoffmann, Sebastian; Hartung, Thomas; Stephens, Martin

Pages: 231 –241

[Evidence-based toxicology (EBT) was introduced independently by two groups in 2005, in the context of toxicological risk assessment and causation as well as based on parallels between the evaluation of test methods in toxicology and evidence-based assessment of diagnostics tests in medicine. The...
LitStream

Chapter 10Validation of Transcriptomics-Based In Vitro Methods

Corvi, Raffaella; Vilardell, Mireia; Aubrecht, Jiri; Piersma, Aldert

Pages: 243 –257

[The field of transcriptomics has expanded rapidly during the last decades. This methodology provides an exceptional framework to study not only molecular changes underlying the adverse effects of a given compound, but also to understand its Mode of Action (MoA). However, the implementation of...

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