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The utility of modeling and simulation in drug development and regulatory review

Shiew-Mei Huang1, Darrell R Abernethy, Yaning Wang

  • 1Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA. ShiewMei.Huang@FDA.HHS.GOV

Journal of Pharmaceutical Sciences
|May 29, 2013
PubMed

Keywords:
Modeling and simulationPBPKdose-responsedrug interactionspharamcokineticspharmacodynamicsregulatory sciencesystems pharmacology

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