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Design and Data Analysis in Drug Interaction Studies

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Drug Interactions in Infectious Diseases

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 2 period randomized cross-over study with two treatment sequences; however, more complex and alternative study designs are discussed. Considerations include dose and duration of precipitant drug, 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 bioequivalence testing and to present mean ratio of Treatment/Reference and corresponding 90% confidence intervals. The “no-effect” bounds, typically 80.00–125.0%, 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. College of Pharmacy, The University of Arizona, 1205 North Martin, Tucson, AZ, 85721-0207, USA

    David E. Nix

  2. Biopharmaceutics, Watson Pharmaceuticals, Corona, CA, USA

    Keith Gallicano

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  1. David E. Nix
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  2. Keith Gallicano
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Correspondence to David E. Nix .

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Editors and Affiliations

  1. , Infectious Diseases, GlaxoSmithKline, Research Triangle Park, 27709, North Carolina, USA

    Stephen C. Piscitelli

  2. College of Pharmacy, Dept. Pharmacy Practice, University of Illinois, Chicago, Chicago, 60612-7230, Illinois, USA

    Keith A. Rodvold

  3. , Pharmaceutical Sciences, Albany College of Pharmacy, Albany, 12208, New York, USA

    Manjunath P. Pai

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Nix, D.E., Gallicano, K. (2011). Design and Data Analysis in Drug Interaction Studies. In: Piscitelli, S., Rodvold, K., Pai, M. (eds) Drug Interactions in Infectious Diseases. Infectious Disease. Humana Press. https://doi.org/10.1007/978-1-61779-213-7_20

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