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A Systems Approach to Designing Effective Clinical Trials Using Simulations
Author(s) -
Vincent A. Fusaro,
Prasad Patil,
Chih-Lin Chi,
Charles F. Contant,
Peter J. Tonellato
Publication year - 2012
Publication title -
circulation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 7.795
H-Index - 607
eISSN - 1524-4539
pISSN - 0009-7322
DOI - 10.1161/circulationaha.112.123034
Subject(s) - dosing , medicine , pharmacogenetics , clinical trial , clinical study design , warfarin , protocol (science) , population , pharmacodynamics , intensive care medicine , medical physics , pharmacokinetics , pharmacology , alternative medicine , chemistry , environmental health , genotype , gene , atrial fibrillation , biochemistry , pathology
Pharmacogenetics in warfarin clinical trials have failed to show a significant benefit in comparison with standard clinical therapy. This study demonstrates a computational framework to systematically evaluate preclinical trial design of target population, pharmacogenetic algorithms, and dosing protocols to optimize primary outcomes.

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