Carr G P, Wahlich J C
Medgenix Group, Fleurus, Belgium, UK.
J Pharm Biomed Anal. 1990;8(8-12):613-8. doi: 10.1016/0731-7085(90)80090-c.
Guidelines issued by Regulatory Authorities make it clear that validation of analytical methodology is now widely required in support of registration dossiers. Although some attempts are made at defining terms and some vague indications are sometimes provided within these guidelines, no clear advice is provided on how validations should be conducted and what results should be expected. In this paper it is attempted to suggest some practical approaches to conducting validation and in particular to the determination of accuracy, linearity and limit of detection/quantitation.
监管机构发布的指南明确指出，目前广泛要求对分析方法进行验证以支持注册文件。尽管在定义术语方面有所尝试，并且这些指南中有时也会给出一些模糊的指示，但对于应如何进行验证以及预期会得到什么结果，并未提供明确的建议。本文试图提出一些进行验证的实用方法，尤其是关于准确度、线性以及检测限/定量限的测定方法。
