Virus assay methods: Accuracy and validation

被引：80

作者：

Darling, AJ ^{[1
]}

Boose, JA ^{[1
]}

Spaltro, J ^{[1
]}

机构：

[1] MA Bioserv Inc, Rockville, MD 20850 USA

来源：

BIOLOGICALS | 1998年 / 26卷 / 02期

关键词：

D O I：

10.1006/biol.1998.0134

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

Assay validation is the characterization of assay performance that allows the significance of the values obtained in an assay to be evaluated. Biological assays have several inherent sources of variation and this has been used as an excuse for years to explain unexpected or unanticipated results. However,with careful control of reagents and strictly controlled procedures, biological assays can be successfully validated to allow accurate quantitation and interpretation of the results obtained. (C) 1998 The International Association of Biological Standardization.

引用

页码：105 / 110

页数：6

共 9 条

[1]

Center for Biologics Evaluation and Research, 1997, POINTS CONS MAN TEST

[2]

Darling A, 1996, BIOPHARM OCT, P42

[3]

*EUR AG EV MED PRO, 1997, CPMPICH29595 EUR AG

[4]

*FED HLTH OFF P ER, 1994, BUNDESANZEIGER, V84, P4742

[5]

LITTLE LE, 1995, BIOPHARM NOV, P36

[6]

*OFF BIOL RES REV, 1993, POINTS CONS CHAR CEL

[7]

Spearman C, 1974, VIROLOGISCHE ARBEITS, P37

[8]

The European Agency for Evaluation of Medicinal Products Human Medicines Evaluation Unit, 1996, CPMPBWP26895 EUR AG

[9]

1995, FED REG 0301, V4, P11259

← 1 →