A strategy for validation of bioanalytical methods

被引：154

作者：

Braggio, S

Barnaby, RJ

Grossi, P

Cugola, M

机构：

[1] Glaxo-Wellcome Research Laboratories, Drug Metabolism Department, Glaxo Wellcome S.p.A., 37135 Verona, via A. Fleming

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 1996年 / 14卷 / 04期

关键词：

bioanalytical methods; drug development; validation;

D O I：

10.1016/0731-7085(95)01644-9

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

[No abstract available]

引用

收藏

页码：375 / 388

页数：14

相关论文

共 19 条

[1] ABBOT RW, 1994, BIOFLUIDS TISSUE ANA, V23, P255
[2] METHOD VALIDATION IN THE BIOANALYTICAL LABORATORY
BUICK, AR
DOIG, MV
JEAL, SC
LAND, GS
MCDOWALL, RD
[J]. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 1990, 8 (8-12) : 629 - 637
[3] Cartwright A, 1991, DRUG INF J, V25, P471, DOI [10.1177/009286159102500402, DOI 10.1177/009286159102500402]
[4] EVALUATION OF CRITERIA FOR THE ACCEPTANCE OF BIOANALYTICAL DATA
CAUSEY, AG
HILL, HM
PHILLIPS, LJ
[J]. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 1990, 8 (8-12) : 625 - 628
[5] A NEW RADIOIMMUNOASSAY OF THIORIDAZINE AND ITS COMPARISON WITH A HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHIC METHOD AND ANOTHER RADIOIMMUNOASSAY
CHAKRABORTY, BS
HAWES, EM
ROSENTHALER, J
MIDHA, KK
[J]. THERAPEUTIC DRUG MONITORING, 1987, 9 (02) : 227 - 235
[6] *EUR COMM COMM LUX, CPMP NOT GUID AN VAL
[7] ENANTIOSELECTIVE DETERMINATION OF HYDROXYCHLOROQUINE AND ITS MAJOR METABOLITES IN URINE AND THE OBSERVATION OF A REVERSAL IN THE (+)-(-)-HYDROXYCHLOROQUINE RATIO
FIEGER, H
IREDALE, J
WAINER, IW
[J]. CHIRALITY, 1993, 5 (02) : 65 - 70
[8] AN ANALYSIS OF THE WASHINGTON CONFERENCE REPORT ON BIOANALYTICAL METHOD VALIDATION
HARTMANN, C
MASSART, DL
MCDOWALL, RD
[J]. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 1994, 12 (11) : 1337 - 1343
[9] *INT ORG STAND STA, 1989, ISO STANDARDS HDB, V3
[10] STEREOCHEMISTRY AND BIOEQUIVALENCE
JAMALI, F
[J]. JOURNAL OF CLINICAL PHARMACOLOGY, 1992, 32 (10) : 930 - 934