Quantitative Solutions, Inc., Menlo Park, California, USA.
Clin Pharmacol Ther. 2011 Dec;90(6):766-9. doi: 10.1038/clpt.2011.242.
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.
高开发成本、低开发成功率、成本约束的医疗保健政策和激烈的竞争都要求药物开发过程高效。与现有治疗方案相比，新化合物需要通过安全、有效和具有成本效益来为患者带来价值。基于模型的荟萃分析（MBMA）有助于综合利用汇总疗效和安全性数据，为比较疗效和安全性评估提供定量框架。本文讨论了 MBMA 在药物开发中的应用和局限性。
