Evaluation of various static in vitro-in vivo extrapolation models for risk assessment of the CYP3A inhibition potential of an investigational drug.

@article{Vieira2014EvaluationOV,
  title={Evaluation of various static in vitro-in vivo extrapolation models for risk assessment of the CYP3A inhibition potential of an investigational drug.},
  author={M D L T Vieira and Brian J Kirby and Isabelle Ragueneau-Majlessi and Aleksandra Galetin and J. Y. L. Chien and Heidi J. Einolf and Odette A. Fahmi and Volker G. Fischer and Adrian J. Fretland and Kenneth H Grime and Stephen D. Hall and Richard E. Higgs and David Plowchalk and Rob Riley and Eleanore Seibert and Konstantine Skordos and Jan Snoeys and Karthik Venkatakrishnan and Timothy H. Waterhouse and R Scott Obach and Eva Gil Berglund and Lei Zhang and Peimin Zhao and Kellie Schoolar Reynolds and S M Huang},
  journal={Clinical pharmacology and therapeutics},
  year={2014},
  volume={95 2},
  pages={189-98}
}
Nine static models (seven basic and two mechanistic) and their respective cutoff values used for predicting cytochrome P450 3A (CYP3A) inhibition, as recommended by the US Food and Drug Administration and the European Medicines Agency, were evaluated using data from 119 clinical studies with orally administered midazolam as a substrate. Positive predictive error (PPE) and negative predictive error (NPE) rates were used to assess model performance, based on a cutoff of 1.25-fold change in… CONTINUE READING

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