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Validation of Alternative Methods for Toxicity Testing

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Cover of 'Validation of Alternative Methods for Toxicity Testing'

Table of Contents

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    Book Overview
  2. Altmetric Badge
    Chapter 1 Introduction.
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    Chapter 2 Validation in Support of Internationally Harmonised OECD Test Guidelines for Assessing the Safety of Chemicals.
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    Chapter 3 Regulatory Acceptance of Alternative Methods in the Development and Approval of Pharmaceuticals.
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    Chapter 4 Validation of Alternative In Vitro Methods to Animal Testing: Concepts, Challenges, Processes and Tools.
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    Chapter 5 Practical Aspects of Designing and Conducting Validation Studies Involving Multi-study Trials.
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    Chapter 6 Validation of Computational Methods.
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    Chapter 7 Implementation of New Test Methods into Practical Testing.
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    Chapter 8 Pathway Based Toxicology and Fit-for-Purpose Assays.
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    Chapter 9 Evidence-Based Toxicology.
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    Chapter 10 Validation of Transcriptomics-Based In Vitro Methods.
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    Chapter 11 Ensuring the Quality of Stem Cell-Derived In Vitro Models for Toxicity Testing.
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    Chapter 12 Validation of Bioreactor and Human-on-a-Chip Devices for Chemical Safety Assessment.
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    Chapter 13 Integrated Approaches to Testing and Assessment.
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    Chapter 14 International Harmonization and Cooperation in the Validation of Alternative Methods.
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    Chapter 15 Evolving the Principles and Practice of Validation for New Alternative Approaches to Toxicity Testing.
Attention for Chapter 11: Ensuring the Quality of Stem Cell-Derived In Vitro Models for Toxicity Testing.
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Chapter title
Ensuring the Quality of Stem Cell-Derived In Vitro Models for Toxicity Testing.
Chapter number 11
Book title
Validation of Alternative Methods for Toxicity Testing
Published in
Advances in experimental medicine and biology, September 2016
DOI 10.1007/978-3-319-33826-2_11
Pubmed ID
Book ISBNs
978-3-31-933824-8, 978-3-31-933826-2
Authors

Glyn N. Stacey, Sandra Coecke, Anna-Bal Price, Lyn Healy, Paul Jennings, Anja Wilmes, Christian Pinset, Magnus Ingelman-Sundberg, Jochem Louisse, Simone Haupt, Darren Kidd, Andrea Robitski, Heinz-Georg Jahnke, Gilles Lemaitre, Glenn Myatt

Editors

Chantra Eskes, Maurice Whelan

Abstract

Quality control of cell cultures used in new in vitro toxicology assays is crucial to the provision of reliable, reproducible and accurate toxicity data on new drugs or constituents of new consumer products. This chapter explores the key scientific and ethical criteria that must be addressed at the earliest stages of developing toxicology assays based on human pluripotent stem cell (hPSC) lines. It also identifies key considerations for such assays to be acceptable for regulatory, laboratory safety and commercial purposes. Also addressed is the development of hPSC-based assays for the tissue and cell types of greatest interest in drug toxicology. The chapter draws on a range of expert opinion within the European Commission/Cosmetics Europe-funded alternative testing cluster SEURAT-1 and consensus from international groups delivering this guidance such as the International Stem Cell Banking Initiative. Accordingly, the chapter summarizes the most up-date best practices in the use and quality control of human Pluripotent Stem Cell lines in the development of in vitro toxicity assays from leading experts in the field.

Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 28 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 28 100%

Demographic breakdown

Readers by professional status Count As %
Researcher 9 32%
Other 3 11%
Student > Bachelor 3 11%
Student > Master 3 11%
Student > Doctoral Student 1 4%
Other 1 4%
Unknown 8 29%
Readers by discipline Count As %
Pharmacology, Toxicology and Pharmaceutical Science 5 18%
Biochemistry, Genetics and Molecular Biology 5 18%
Agricultural and Biological Sciences 2 7%
Nursing and Health Professions 1 4%
Environmental Science 1 4%
Other 5 18%
Unknown 9 32%