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FY2016 Regulatory Science Report: Narrow Therapeutic Index Drugs

This section contains only new information from FY2016. For background scientific information and outcomes from previous years on this research topic, please refer to the FY15 Regulatory Science Research Report on Narrow Therapeutic Index Drugs.

ORS staff facilitating research in this area

  • Lanyan Fang, Wenlei Jiang, Zhichuan Li, Xinyuan Zhang , Jianghong Fan, Hyewon Kim, and other ORS staff members

Projects and Collaborators

  • Population pharmacokinetic and pharmacodynamic, dose-toxicity modeling and simulation for narrow therapeutic index (NTI) drugs
    • Site PI: Jogarao V Gobburu
    • Grant #: 1U01FD005188-01
  • Clinical practice data to aid narrow therapeutic index drug classification
    • Site PI: Michael Cohen-Wolkowiez
    • Grant #: 1U01FD004858-01
  • Pharmacometric modeling and simulation for a generic drug substitutability evaluation and post marketing risk assessment
    • Site PI: Jogarao V Gobburu
    • Grant #: 1U01FD005192-01
  • A model- and systems-based approach to efficacy and safety questions related to generic substitution
    • Site PI: Lawrence Lesko
    • Grant #: 1U01FD005210-01
  • Pharmacometric modeling of immunosuppressants for evaluation of bioequivalence criteria
    • Site PI: Catherine Mary Turner Sherwin
    • Grant #: 1U01FD005191-01
  • Therapeutic index evaluation for tacrolimus and levetiracetam
    • Site PI: William A. Clarke
    • Grant #: 1U01FD004859-01

Publications and Presentations

  • Dahmane E, Penzenstadler J, Gopalakrishnan M, Gobburu J, Ivaturi V. Do anti-epileptic drug follow the FDA definitions for narrow therapeutic index drug? American Epilepsy Society. (Dec 7, 2015)
  • Dahmane E, Gopalakrishnan M, Zhao L, Fang L, Gobburu J, Ivaturi V. Impact of Variability on Therapeutic Success for Drugs with Narrow Therapeutic Index. American College of Clinical Pharmacology. (Sep 26, 2016)
  • Lanyan Fang. Bioequivalence Study Designs for Anti-Epileptic Drugs (AED). Invited talk at American Epilepsy Society. (Dec 5, 2016)
  • Dahmane E, Gopalakrishnan M, Fang L, Gobburu J, Ivaturi V. Impact of between-subject and between occasion variability on therapeutic success for narrow therapeutic index drugs: a bioequivalence perspective. American Society for Clinical Pharmacology and Therapeutics. (Mar 16, 2017)




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