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Clinical Studies in Geriatric Population

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Drug Discovery and Evaluation: Methods in Clinical Pharmacology

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Abstract

Exclusion of the older population from clinical trials has for long resulted in a knowledge gap about drug efficacy and side effects in older age groups. When considering the demographic change in most industrialized countries and the fact that seniors receive the highest share of all drugs, a need for clinical trials with elderly patients is obvious. Potential pharmacokinetic as well as pharmacodynamic changes in comparison to younger adults have to be described. The safety profile can be different due to several reasons, which may be explained by comorbidities, comedications, or age-related changes. Calendar age serves only as a proxy for age, and geriatric assessment tools should more and more be applied to characterize the heterogenous group of older adults from 65 years to more than 100 years of age. Several ICH guidelines and reflection papers from regulatory bodies do exist and offer advice on how to design and analyze clinical trials including the older population.

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Author information

Authors and Affiliations

  1. Philipp Klee-Institute of Clinical Pharmacology, HELIOS University Clinic Wuppertal, Wuppertal, Germany

    Petra A. Thürmann

  2. University Witten/Herdecke, Witten, Germany

    Petra A. Thürmann

Authors
  1. Petra A. Thürmann
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Correspondence to Petra A. Thürmann .

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Editors and Affiliations

  1. CorDynamics , Dieburg, Germany

    Franz J. Hock

  2. CorDynamics , Chicago, IL, USA

    Michael R. Gralinski

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Thürmann, P.A. (2019). Clinical Studies in Geriatric Population. 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_43-1

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  • DOI: https://doi.org/10.1007/978-3-319-56637-5_43-1

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  • Print ISBN: 978-3-319-56637-5

  • Online ISBN: 978-3-319-56637-5

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