Office of Research and Standards, Office of Generic Drugs, US Food and Drug Administration Silver Spring, Maryland, USA.
Clin Pharmacol Ther. 2019 Apr;105(4):878-885. doi: 10.1002/cpt.1364. Epub 2019 Mar 2.
Regulatory science is science and research intended to improve decision making in a regulatory framework. Improvements in decision making can be in both accuracy (making better decisions) and in efficiency (making faster decisions). Science and research supported by the Generic Drug User Fee Amendments of 2012 (GDUFA) have focused on two innovative methodologies that work together to enable new approaches to development and review of generic drugs: quantitative models and advanced in vitro product characterization. Quantitative models faithfully represent current scientific understanding. They are tools pharmaceutical scientists and clinical pharmacologists use for making better and faster product development decisions. Advances in the in vitro product comparisons provide the measurements of product differences that are the critical input into the models. This paper outlines four areas where science and research funded by GDUFA support synergistic use of models and characterization at critical decision points during generic drug product development and review.
监管科学是旨在改善监管框架下决策制定的科学和研究。决策制定的改进可以体现在准确性（做出更好的决策）和效率（做出更快的决策）上。由 2012 年仿制药使用者付费修正案（GDUFA）支持的科学和研究集中于两种创新方法，它们共同为开发和审查仿制药提供新方法：定量模型和先进的体外产品特性。定量模型忠实地反映了当前的科学理解。它们是制药科学家和临床药理学家用来做出更好和更快的产品开发决策的工具。体外产品比较方面的进展提供了产品差异的测量值，这些测量值是模型的关键输入。本文概述了 GDUFA 资助的科学和研究在仿制药产品开发和审查的关键决策点支持模型和特性的协同使用的四个领域。
