Pharmacokinetic and pharmacodynamic studies in older adults

Arduino Mangoni, Paul Jansen, Stephen Jackson

    Research output: Chapter in Book/Report/Conference proceedingChapterpeer-review

    1 Citation (Scopus)


    The older population represents the largest consumer group for medications. Age-associated pharmacokinetic and pharmacodynamic changes, reduced homeostasis, frailty, and drug-drug interactions increase the risk of adverse drug reactions (ADRs) in older patients. A better understanding of drug efficacy and safety profiles in this vulnerable group would help tailoring dosage and treatment monitoring before introduction into clinical practice. However, a very limited number of older subjects have participated in Phase I-III clinical trials hitherto. This chapter discusses the current knowledge on the main age-related changes in pharmacokinetics and pharmacodynamics, several important issues to be considered when planning and designing further pharmacokinetic and pharmacodynamic studies in older subjects, and recent regulatory documents on the conduct of such studies.

    Original languageEnglish
    Title of host publicationClinical Trials in Older Adults
    PublisherJohn Wiley & Sons
    Number of pages16
    ISBN (Electronic)9781118323434
    ISBN (Print)9781118323496
    Publication statusPublished - 25 Aug 2015


    • Adverse drug reactions
    • Age
    • Efficacy
    • Liver function
    • Older patients
    • Pharmacodynamics
    • Pharmacokinetics
    • Renal function
    • Safety
    • Study design


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