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Stem Cell-Derived Models for Safety and Toxicity Assessments: Present and Future Studies in the “Proclinical Space”

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Stem Cell-Derived Models in Toxicology

Part of the book series: Methods in Pharmacology and Toxicology ((MIPT))

Abstract

The promise of human, stem cell-derived models for safety and toxicity assessments remains great. Using such preparations it should be possible to provide preclinical assessments of drug effects with human-derived cells and engineered tissues, creating a new “proclinical” paradigm to study human responses without administering drugs to human volunteers or patients. Along with this promise come challenges related to more fully characterizing, standardizing, and understanding these novel preparations, developing the experimental platforms necessary for efficient and reproducible studies, and validation studies demonstrating overall utility of various models. This chapter describes some issues encountered with the development of human-induced stem cell-derived cardiomyocytes for safety and toxicity studies with evolving drug candidates, along with a discussion of the role of future proclinical studies as part of an integrated package of more traditional safety and toxicology assessments.

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Authors and Affiliations

  1. AbbVie, Integrative Pharm., Integrated Science and Technology, Dept. ZR-13 Bldg AP-9A-LL, 1 North Waukegan Rd., North Chicago, IL, 60064-6118, USA

    Gary Gintant

  2. Pluriomics BV, Biopartner building 3, Galileiweg 8, 2333 BD, Leiden, The Netherlands

    Stefan Braam

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  1. Gary Gintant
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  2. Stefan Braam
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Correspondence to Gary Gintant .

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Editors and Affiliations

  1. Axion BioSystems, Inc., Atlanta, Georgia, USA

    Mike Clements

  2. Cell Applications, GE Healthcare, Cardiff, United Kingdom

    Liz Roquemore

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Gintant, G., Braam, S. (2017). Stem Cell-Derived Models for Safety and Toxicity Assessments: Present and Future Studies in the “Proclinical Space”. In: Clements, M., Roquemore, L. (eds) Stem Cell-Derived Models in Toxicology. Methods in Pharmacology and Toxicology. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-6661-5_1

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  • DOI: https://doi.org/10.1007/978-1-4939-6661-5_1

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  • Print ISBN: 978-1-4939-6659-2

  • Online ISBN: 978-1-4939-6661-5

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