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In Vitro/In Vivo Correlation for Drug-Drug Interactions

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Drug Discovery and Evaluation: Methods in Clinical Pharmacology

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Abstract

Characterizing the potential for drug-drug interactions is critical to underwriting patient safety as new chemical entities proceed through the drug discovery and development pipeline. In vitro experiments to characterize the type and extent of interaction have been developed to inform chemical modifications early in discovery and to estimate the magnitude of potential interactions as drugs progress into the clinic. Regulatory guidance provides flow schemes based on a comprehensive understanding of drug disposition to enable decision-making as to whether particular clinical interaction studies need to be run and, if so, how they may be designed. Integration of information from in vitro, in vivo, and clinical sources provides the basis for drug labeling and the safe administration of drugs post-launch.

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Authors and Affiliations

  1. Amgen, Inc, Pharmacokinetics and Drug Metabolism, One Amgen Center Drive, Mail stop 30E-2-B, Thousand Oaks, CA, USA

    Jan Wahlstrom

  2. Amgen, Inc, Pharmacokinetics and Drug Metabolism, South San Francisco, CA, USA

    Larry Wienkers

Authors
  1. Jan Wahlstrom
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  2. Larry Wienkers
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Corresponding author

Correspondence to Larry Wienkers .

Editor information

Editors and Affiliations

  1. CorDynamics , Dieburg, Germany

    Franz J. Hock

  2. CorDynamics , Chicago, Illinois, USA

    Michael R. Gralinski

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Wahlstrom, J., Wienkers, L. (2018). In Vitro/In Vivo Correlation for Drug-Drug Interactions. 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_14-1

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  • DOI: https://doi.org/10.1007/978-3-319-56637-5_14-1

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-56637-5

  • Online ISBN: 978-3-319-56637-5

  • eBook Packages: Springer Reference Biomedicine and Life SciencesReference Module Biomedical and Life Sciences

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