A practical guide to analytical method validation

被引：410

作者：

Green, JM

机构：

来源：

ANALYTICAL CHEMISTRY | 1996年 / 68卷 / 09期

关键词：

D O I：

10.1021/ac961912f

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

引用

页码：A305 / A309

页数：5

共 13 条

[1]

ADAMOVICS JA, 1990, CHROMATOGRAPHIC ANAL

[2]

[Anonymous], PHARM TECH

[3] A PRACTICAL APPROACH TO METHOD VALIDATION IN PHARMACEUTICAL ANALYSIS [J].

CARR, GP ;

WAHLICH, JC .

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 1990, 8 (8-12) :613-618

[4]

CASSIDY R, 1992, LC GC-MAG SEP SCI, V10, P692

[5] THE VALIDATION OF ANALYTICAL METHODS FOR DRUG SUBSTANCES AND DRUG PRODUCTS IN UK PHARMACEUTICAL LABORATORIES [J].

CLARKE, GS .

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 1994, 12 (05) :643-652

[6] LC DETECTORS - EVALUATION AND PRACTICAL IMPLICATIONS OF LINEARITY [J].

DORSCHEL, CA ;

EKMANIS, JL ;

OBERHOLTZER, JE ;

WARREN, FV ;

BIDLINGMEYER, BA .

ANALYTICAL CHEMISTRY, 1989, 61 (17) :A951-&

[7]

Food and Drug Administration,, 1994, REV GUID VAL CHROM M

[8]

*FOOD DRUG ADM, 1987, GUID SUBM SAMPL AN D

[9] GENERAL-METHOD VALIDATION GUIDELINES FOR PHARMACEUTICAL SAMPLES [J].

INMAN, EL ;

FRISCHMANN, JK ;

JIMENEZ, PJ ;

WINKEL, GD ;

PERSINGER, ML ;

RUTHERFORD, BS .

JOURNAL OF CHROMATOGRAPHIC SCIENCE, 1987, 25 (06) :252-256

[10]

Virlichie J. L., 1995, STP PHARM PRATIQUES, V5, P37

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