Building the Global Bioanalysis Consortium - working towards a functional globally acceptable and harmonized guideline on bioanalytical method validation

被引：34

作者：

van Amsterdam, Peter ^{[1
]}

Arnold, Mark ^{[2
]}

Bansal, Surendra

Fast, Douglas

Garofolo, Fabio

Lowes, Steve

Timmerman, Philip

Woolf, Eric

机构：

[1] Abbott Healtcare Prod BV, NL-1381 CP Weesp, Netherlands

[2] Bristol Myers Squibb Co, Bioanalyt Sci, Bristol, NJ USA

来源：

BIOANALYSIS | 2010年 / 2卷 / 11期

关键词：

bioanalysis; GBC; global; Global Bioanalysis Consortium; guidelines; harmonization; health authorities; pharma; GUIDANCE;

D O I：

10.4155/BIO.10.146

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

引用

页码：1801 / 1803

页数：3

共 9 条

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[2]

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[3]

*EBF, 3 OP C CHALL SOL

[4]

*EMA, EMA DRAFT GUID VAL B

[5]

*FIP PHARM SCI, 2010, WORLD C AAPS ANN M E

[6]

Savoie N, 2010, BIOANALYSIS, V2, P1945, DOI [10.4155/bio.10.164, 10.4155/BIO.10.164]

[7] Request for Global Harmonization of the Guidance for Bioanalytical Method Validation and Sample Analysis [J].

Timmerman, Philip ;

Lowes, Steve ;

Fast, Douglas M. ;

Garofolo, Fabio .

BIOANALYSIS, 2010, 2 (04) :683-683

[8] Towards harmonized regulations for bioanalysis: moving forward! [J].

van Amsterdam, Peter ;

Lausecker, Berthold ;

Luedtke, Silke ;

Timmerman, Philip ;

Brudny-Kloeppel, Margarete .

BIOANALYSIS, 2010, 2 (04) :689-691

[9]

1 WORKSH AS PAC REC

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