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Clin Pharmacol Ther. 2011 Dec;90(6):766-9. doi: 10.1038/clpt.2011.242.

Model-based meta-analysis for comparative efficacy and safety: application in drug development and beyond.

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  • 1Quantitative Solutions, Inc., Menlo Park, California, USA. jmandema@wequantify.com


High development cost, low development success, cost-disciplined health-care policies, and intense competition demand an efficient drug development process. New compounds need to bring value to patients by being safe, efficacious, and cost-effective as compared with existing treatment options. Model-based meta-analysis (MBMA) facilitates integration and utilization of summary-level efficacy and safety data, providing a quantitative framework for comparative efficacy and safety assessment. This Commentary discusses the application and limitations of MBMA in drug development.

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