Ball S E, Scatina J A, Sisenwine S F, Fisher G L
Drug Safety and Metabolism, Wyeth-Ayerst Research, Princeton, NJ, USA.
Drug Chem Toxicol. 1995 Feb;18(1):1-28. doi: 10.3109/01480549509017855.
In vitro models are being used increasingly during all phases of the drug development process in concert with the more traditional in vivo toxicological and pharmacokinetic evaluations. These in vitro models may be classified empirically as either validated in vitro screens, value-added screens or 'ad-hoc' mechanistic screens. The application of these screens is discussed with respect to their level of validation, standardization, uses of human tissue, level of iteration with in vivo studies, regulatory position and utility in the drug discovery and development process. The predictability and reproducibility of these screens is discussed, as well as future trends in regard to emerging technology and its application.
在药物研发过程的各个阶段，体外模型正越来越多地与更为传统的体内毒理学和药代动力学评估协同使用。这些体外模型根据经验可分为经过验证的体外筛选模型、增值筛选模型或“临时”机制筛选模型。本文将从验证水平、标准化程度、人体组织的使用情况、与体内研究的迭代程度、监管立场以及在药物发现和开发过程中的效用等方面讨论这些筛选模型的应用。文中还讨论了这些筛选模型的可预测性和可重复性，以及新兴技术及其应用的未来趋势。
