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Toxicity Testing In Vitro: Regulatory Aspects

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Regulatory Toxicology
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Abstract

In vitro testing in toxicology was limited for a long time to testing for possible genotoxic properties of a substance. Cell or tissue culture methods are now used for the early toxicological assessment of new substances within the context of screening tests and for mechanistic investigations. In this respect, in vitro methods represent a valuable adjunct to animal studies, without being able to replace animal studies completely at the present time. New developments in the area of microphysiological systems (MPS) suggest that in specific cases like the development of biologics as pharmaceuticals, where relevant animal models are not available due to the human-specific nature of the biologic, but also for improved mechanistic evaluations, human in vitro models will be required or at least deliver helpful information.

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von Keutz, E. (2021). Toxicity Testing In Vitro: Regulatory Aspects. In: Reichl, FX., Schwenk, M. (eds) Regulatory Toxicology . Springer, Cham. https://doi.org/10.1007/978-3-030-57499-4_35

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