Validation of bioanalytical chromatographic methods

被引:217
作者
Hartmann, C
Smeyers-Verbeke, J
Massart, DL
McDowall, RD
机构
[1] Free Univ Brussels, Inst Pharmaceut, B-1090 Brussels, Belgium
[2] Univ Surrey, Dept Chem, Guildford GU2 5XH, Surrey, England
关键词
bioanalytical method validation; experimental design; hypothesis testing; bias; precision;
D O I
10.1016/S0731-7085(97)00198-2
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
A strategy is discussed for the validation of chromatographic methods that are developed to quantify drugs in biological matrices. Both the validation terminology and the hypothesis testing are briefly reviewed. The emphasis is on the design of the experiments required to allow a reliable conclusion about acceptance or rejection of the bioanalytical method. In particular, it is explained how to evaluate the calibration line, devise experiments to estimate precision and bias and how to determine the stability of the analyte between the time of the sample collection and the analysis of the processed sample. (C) 1998 Elsevier Science B.V. All rights reserved.
引用
收藏
页码:193 / 218
页数:26
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