Design and Data Analysis in Drug Interaction Studies

Chapter
Part of the Infectious Disease book series (ID)

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.

Keywords

Drug interactions Pharmacokinetics Pharmacodynamics Study design Data analysis Regulatory guidance Crossover design Parallel design Absorption Distribution Metabolism Renal excretion Transporters Pharmacogenomics Statistics 

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Copyright information

© Springer International Publishing AG 2018

Authors and Affiliations

  1. 1.The University of Arizona College of PharmacyTucsonUSA
  2. 2.Novum Pharmaceutical Research ServicesMurrietaUSA

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