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The Human ADME Study

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Drug Discovery and Evaluation: Methods in Clinical Pharmacology

Abstract

Sophisticated in silico (Matter and Schmider 2006) and humanized in vitro models of drug absorption (Mertsch 2006) and drug metabolism (Dudda and Kuerzel 2006b), in combination with animal data (Gupta and Atul 2000; Inskeep and Day 1999), provide excellent predictions of absorption, distribution, metabolism, and excretion (ADME). Nevertheless, a clinical “reality check” of these predictions is needed with a human ADME study (hADME study). This study, also known as a human mass balance study, is comprised of the administration of the NCE in radiolabeled form in order to monitor the compound and its metabolites (Beumer et al. 2006; Roffey et al. 2007; Dalvie et al. 2000; Pool 1999 and references cited therein, Deroubaix and Coquette 2004).

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Author information

Authors and Affiliations

  1. R&D Metabolism and PK Germany, Sanofi-Aventis Deutschland GmbH, Industriepark Hoechst, Building G877, 65926, Frankfurt am Main, Germany

    Ulrich Kuerzel

  2. R&D Metabolism and PK Germany, Sanofi-Aventis Deutschland GmbH, Industriepark Hoechst, Building G876, 65926, Frankfurt am Main, Germany

    Volker Krone & Manfred Zimmer

  3. Global Metabolism and Pharmacokinetics, Sanofi-Aventis, Willowburn Avenue, NE66 2JH, Northumberland, Alnwick, UK

    Gareth Shackleton

Authors
  1. Ulrich Kuerzel
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  2. Volker Krone
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  3. Manfred Zimmer
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  4. Gareth Shackleton
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Correspondence to Ulrich Kuerzel .

Editor information

Editors and Affiliations

  1. Bohl Str. 28, 73430, Aalen, Germany

    Hans Gerhard Vogel

  2. Sanofi Aventis Deutschland GmbH, Industriepark Hoechst, Building G877, R&D Metabolism and PK Germany, 65926, Frankfurt am Main, Germany

    Jochen Maas

  3. Merz Pharmaceuticals GmbH, Eckenheimer Landstraβe 100, 60318, Frankfurt am Main, Germany

    Alexander Gebauer

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Kuerzel, U., Krone, V., Zimmer, M., Shackleton, G. (2011). The Human ADME Study. In: Vogel, H.G., Maas, J., Gebauer, A. (eds) Drug Discovery and Evaluation: Methods in Clinical Pharmacology. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-540-89891-7_11

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