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Model‐Based Benefit–Risk Assessment: Can Archimedes Help?
Author(s) -
Krishna R
Publication year - 2009
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2008.240
Subject(s) - clinical pharmacology , food and drug administration , medicine , risk analysis (engineering) , diabetes mellitus , risk assessment , intensive care medicine , diabetes treatment , drug , pharmacology , type 2 diabetes , computer science , computer security , endocrinology
In December 2008, the US Food and Drug Administration issued a new draft Guidance for Industry on Diabetes Mellitus—evaluating cardiovascular risk in new antidiabetic therapies to treat Type 2 diabetes. This guidance comes at a time when recent discussions have focused on delineation of cardiovascular risk reduction for new antidiabetic drugs. Computational tools that can enable early prediction of cardiovascular risk are reviewed with specific reference to Archimedes (Kaiser Permanente), with an aim of proposing a model‐based solution and enabling decisions to be made as early as possible in the drug development value chain. Clinical Pharmacology & Therapeutics (2009); 85 , 3, 239–240 doi: 10.1038/clpt.2008.240