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Synthesis of Radiolabelled Compounds for Clinical Studies

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Drug Discovery and Evaluation: Methods in Clinical Pharmacology

Abstract

Regulatory requirements, quality-related measures as well as key manufacture, control, and release aspects for the synthesis of radiolabelled drugs for administration to human volunteers as part of clinical human ADME studies are discussed in detail. Additionally this review provides a general overview of synthetic, technical and methodological aspects to be considered for the synthesis of Tritium- and 14C-labelled compounds. Chemical and biochemical methods and new trends for isotope labelling are discussed based on published examples.

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Authors and Affiliations

  1. Integrated Drug Discovery, Medicinal Chemistry, Isotope Chemistry and Metabolite Synthesis Departments (ICMS), Sanofi-Aventis Deutschland GmbH, Industriepark Hoechst G876, 65926, Frankfurt a. M, Germany

    Jens Atzrodt, Volker Derdau & Claudia Loewe

Authors
  1. Jens Atzrodt
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  2. Volker Derdau
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  3. Claudia Loewe
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Correspondence to Jens Atzrodt .

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Editors and Affiliations

  1. CorDynamics , Dieburg, Germany

    Franz J. Hock

  2. CorDynamics , Chicago, Illinois, USA

    Michael R. Gralinski

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Atzrodt, J., Derdau, V., Loewe, C. (2017). Synthesis of Radiolabelled Compounds for Clinical Studies. 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_12-1

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  • DOI: https://doi.org/10.1007/978-3-319-56637-5_12-1

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