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Design and Data Analysis in Drug Interaction Studies

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Drug Interactions in Infectious Diseases: Mechanisms and Models of Drug Interactions

Part of the book series: Infectious Disease ((ID))

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Abstract

This chapter covers basic concepts pertaining to designing drug-drug interaction studies and interpreting results. Planning a drug-drug interaction study should encompass a statement of the rationale for doing the study. The basic design involves a two-period randomized crossover study with two treatment sequences; however, more complex and alternative study designs are discussed. Considerations include dose and duration of precipitant drug administration, washout period between treatments, and whether the potential interaction that results will affect the pharmacokinetic assessment plan. Existing information available for the test agents should be reviewed to formulate expected outcomes. The expected outcomes should be considered to ensure that the proper pharmacokinetic and sometimes pharmacodynamic information is collected for all treatments. All drug-drug interaction studies should be planned to incorporate equivalence testing and to present mean ratio of treatment/reference and corresponding 90% confidence intervals. The “no-effect” bounds, typically 80.00–125.00%, should be stated in the plan and based on consideration of the therapeutic index and pharmacokinetic variability of the object drug.

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Authors and Affiliations

  1. The University of Arizona College of Pharmacy, Tucson, AZ, USA

    David E. Nix

  2. Novum Pharmaceutical Research Services, Murrieta, CA, USA

    Keith Gallicano

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Correspondence to David E. Nix .

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Editors and Affiliations

  1. College of Pharmacy, University of Michigan, Ann Arbor, Michigan, USA

    Manjunath P. Pai

  2. Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, Colorado, USA

    Jennifer J. Kiser

  3. Division of Pharmacy Practice and Administration, UMKC School of Pharmacy at MSU, Springfield, Missouri, USA

    Paul O. Gubbins

  4. College of Pharmacy and Medicine, University of Illinois at Chicago, Chicago, Illinois, USA

    Keith A. Rodvold

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Nix, D.E., Gallicano, K. (2018). Design and Data Analysis in Drug Interaction Studies. In: Pai, M., Kiser, J., Gubbins, P., Rodvold, K. (eds) Drug Interactions in Infectious Diseases: Mechanisms and Models of Drug Interactions. Infectious Disease. Humana Press, Cham. https://doi.org/10.1007/978-3-319-72422-5_9

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