Tutorial: Statistical analysis and reporting of clinical pharmacokinetic studies

Ann-Cathrine Dalgård Dunvald, Ditte Bork Iversen, Andreas Ludvig Ohm Svendsen, Katrine Agergaard, Ida Berglund Kuhlmann, Christina Mortensen, Nanna Elman Andersen, Erkka Järvinen, Tore Bjerregaard Stage*

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

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Abstract

Pharmacokinetics is the cornerstone of understanding drug absorption, distribution, metabolism, and elimination. It is also the key to describing variability in drug response caused by drug-drug interactions (DDIs), pharmacogenetics, impaired kidney and liver function, etc. This tutorial aims to provide a guideline and step-by-step tutorial on essential considerations when designing clinical pharmacokinetic studies and reporting results. This includes a comprehensive guide on how to conduct the statistical analysis and a complete code for the statistical software R. As an example, we created a mock dataset simulating a clinical pharmacokinetic DDI study with 12 subjects who were administered 2 mg oral midazolam with and without an inducer of cytochrome P450 3A. We provide a step-by-step guide to the statistical analysis of this clinical pharmacokinetic study, including sample size/power calculation, descriptive statistics, noncompartmental analyses, and hypothesis testing. The different analyses and parameters are described in detail, and we provide a complete R code ready to use in supplementary files. Finally, we discuss important considerations when designing and reporting clinical pharmacokinetic studies. The scope of this tutorial is not limited to DDI studies, and with minor adjustments, it applies to all types of clinical pharmacokinetic studies. This work was done by early career researchers for early career researchers. We hope this tutorial may help early career researchers when getting started on their own pharmacokinetic studies. We encourage you to use this as an inspiration and starting point and continuously evolve your statistical skills.

Original languageEnglish
JournalClinical and Translational Science
Volume15
Issue number8
Pages (from-to)1856-1866
ISSN1752-8062
DOIs
Publication statusPublished - Aug 2022

Keywords

  • Cytochrome P-450 CYP3A Inhibitors
  • Cytochrome P-450 CYP3A/metabolism
  • Drug Interactions
  • Humans
  • Midazolam/pharmacokinetics
  • Models, Biological

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