A COMPREHENSIVE METHOD VALIDATION STRATEGY FOR BIOANALYTICAL APPLICATIONS IN THE PHARMACEUTICAL-INDUSTRY .1. EXPERIMENTAL CONSIDERATIONS

被引：49

作者：

LANG, JR ^{[1
]}

BOLTON, S ^{[1
]}

机构：

[1] ST JOHNS UNIV,COLL PHARM & ALLIED HLTH PROFESS,JAMAICA,NY 11439

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 1991年 / 9卷 / 05期

关键词：

METHOD VALIDATION; BIOANALYTICAL METHODS; COMPREHENSIVE STRATEGY; FDA REGULATIONS; PREVALIDATION; VALIDATION PROPER; STUDY PROPER; STATISTICAL ANALYSES; CONFIDENCE LIMITS; CONTROL CHARTS; CALIBRATION STANDARDS; QUALITY CONTROL SAMPLES;

D O I：

10.1016/0731-7085(91)80159-7

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

The method validation strategy described consists of four components which are the prevalidation, validation proper, study proper and statistical analyses. These components constitute the platform upon which to evaluate the reliability and reproducibility of a bioanalytical method. Consideration has been given to emulate the study proper conditions to understand the method's limitations and performance expectations. The validation strategy will be presented in two papers. This first paper will describe the overall validation strategy, and the second paper will discuss the statistical analyses and data interpretation.

引用

页码：357 / 361

页数：5