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首页> 外文期刊>Journal of Pharmacokinetics and Pharmacodynamics >Non-Linear Mixed Effects Modeling – From Methodology and Software Development to Driving Implementation in Drug Development Science
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Non-Linear Mixed Effects Modeling – From Methodology and Software Development to Driving Implementation in Drug Development Science

机译：非线性混合效应建模-从方法论和软件开发到药物开发科学中的驱动实施

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摘要

Few scientific contributions have made significant impact unless there was a champion who had the vision to see the potential for its use in seemingly disparate areas—and who then drove active implementation. In this paper, we present a historical summary of the development of non-linear mixed effects (NLME) modeling up to the more recent extensions of this statistical methodology. The paper places strong emphasis on the pivotal role played by Lewis B. Sheiner (1940–2004), who used this statistical methodology to elucidate solutions to real problems identified in clinical practice and in medical research and on how he drove implementation of the proposed solutions. A succinct overview of the evolution of the NLME modeling methodology is presented as well as ideas on how its expansion helped to provide guidance for a more scientific view of (model-based) drug development that reduces empiricism in favor of critical quantitative thinking and decision making
机译：除非有一位拥护者有远见卓识，希望看到其在看似分散的领域中的应用潜力，然后再积极推动实施，否则很少有科学贡献能够发挥重大作用。在本文中，我们将对非线性混合效应（NLME）建模的发展进行历史总结，直至对该统计方法的最新扩展。本文着重强调了Lewis B. Sheiner（1940–2004）所发挥的关键作用，他使用这种统计方法阐明了在临床实践和医学研究中发现的实际问题的解决方案，以及他如何推动所提出的解决方案的实施。简要概述了NLME建模方法的发展，并提出了有关其扩展如何为更科学的（基于模型的）药物开发提供科学指导的思想，该观点减少了经验主义，而需要批判性的定量思维和决策

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