Inman E L, Frischmann J K, Jimenez P J, Winkel G D, Persinger M L, Rutherford B S
J Chromatogr Sci. 1987 Jun;25(6):252-6. doi: 10.1093/chromsci/25.6.252.
Method validation guidelines, which provide an organizational structure for the design and evaluation of a validation procedure, are presented for a wide range of pharmaceutical applications. The validation guidelines are based on the analyte concentration/sample matrix combination to which the method will be applied. These guidelines include the selection of appropriate validation parameters, design considerations for evaluation, and a discussion of acceptance guidelines for the determination of acceptable method performance. A set of tables is included which illustrates the selection and testing procedure and tailors the entire validation process to the specific characteristics of the determination to be made.
方法验证指南为验证程序的设计和评估提供了组织结构，适用于广泛的制药应用。验证指南基于该方法将应用的分析物浓度/样品基质组合。这些指南包括选择合适的验证参数、评估的设计考量，以及关于确定可接受方法性能的接受准则的讨论。还包括一组表格，这些表格说明了选择和测试程序，并根据待进行测定的具体特性调整整个验证过程。
