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Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays pp 199–255Cite as

Safety Pharmacology in Metabolism Pharmacology

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Abstract

Safety pharmacology is defined as those studies that investigate the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above (ICH-guideline S7A 2001). Safety pharmacology in metabolism pharmacology is of secondary importance in comparison to the safety pharmacology of vital functions (safety pharmacology core battery: cardiovascular, respiratory, and central nervous systems) and therefore listed under “Follow-up and Supplemental Safety Pharmacology Studies (ICH-guideline S7A 2001: Sect. 2.8.2).” In this section of the guideline, the subjects of safety pharmacology in metabolism pharmacology are listed under the topics of “gastrointestinal system” (ICH-guideline S7A 2001: Sect. 2.8.2.3) and “other organ systems” (ICH-guideline S7A 2001: Sect. 2.8.2.4).

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    Prof. Dr. Andreas W. Herling

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Herling, A.W. (2013). Safety Pharmacology in Metabolism Pharmacology. In: Vogel, H.G., Maas, J., Hock, F.J., Mayer, D. (eds) Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-25240-2_7

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