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Status of Safety Pharmacology and Present Guidelines

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Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays

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Abstract

This chapter describes the development from General Pharmacology to Safety Pharmacology. The development of the different ICH guidelines is discussed in detail. A detailed guideline development after the more frequently observed QT-time prolongation is also described. The different strategies prior to the implementation of the ICH Guidelines are also discussed.

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  1. Safety Pharm Consultant, Dieburg, Germany

    Franz J. Hock

  2. University of Goettingen (UMG), Goettingen, Germany

    Gerd Bode

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  1. FJH Safety Pharm Consulting, Dieburg, Hessen, Germany

    Franz J. Hock

  2. Cytokinetics (United States), South San Francisco, CA, USA

    Michael K. Pugsley

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  1. Safety Pharm Consultant, Dieburg, Germany

    Franz J. Hock DSc

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Hock, F.J., Bode, G. (2024). Status of Safety Pharmacology and Present Guidelines. In: Hock, F.J., Pugsley, M.K. (eds) Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays. Springer, Cham. https://doi.org/10.1007/978-3-030-73317-9_1-1

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