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The Human ADME Study

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Drug Discovery and Evaluation: Methods in Clinical Pharmacology

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Abstract

The human mass balance study is a pivotal study in the drug development process. Whilst a reasonable understanding of the absorption, distribution, metabolism and excretion (ADME) properties of the candidate drug will have been determined using pre-clinical models, the ultimate validation is provided following administration to human volunteers. The human ADME (hADME) study provides the link between pre-clinical safety studies and the clinical observations. Whilst described as a mass balance study, the key objective of the hADME study is the quantification, characterisation and identification of drug and drug metabolites present in systemic circulation. An assessment of the relative exposure between clinical subjects and the species used for pre-clinical safety studies enables a complete safety profile to be obtained.

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  1. Reverisco Solutions, Peterborough, UK

    Andrew McEwen

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  1. Andrew McEwen
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Correspondence to Andrew McEwen .

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  1. CorDynamics , Dieburg, Germany

    Franz J. Hock

  2. CorDynamics , Chicago, Illinois, USA

    Michael R. Gralinski

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McEwen, A. (2017). The Human ADME Study. In: Hock, F., Gralinski, M. (eds) Drug Discovery and Evaluation: Methods in Clinical Pharmacology. Springer, Cham. https://doi.org/10.1007/978-3-319-56637-5_11-1

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  • DOI: https://doi.org/10.1007/978-3-319-56637-5_11-1

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