An industry perspective on the US FDA biomarker qualification effort

被引：3

作者：

Arnold, Mark E. ^{[1
]}

机构：

[1] Covance Inc, 115 Silvia St, Trenton, NJ 08628 USA

来源：

BIOANALYSIS | 2018年 / 10卷 / 12期

关键词：

biomarker; Critical Path; harmonization; regulations; validation; ASSAY VALIDATION;

D O I：

10.4155/bio-2018-0049

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

引用

页码：913 / 916

页数：4

共 10 条

[1]

[Anonymous], 2013, DRAFT GUID IND BIOAN

[2] Workshop Report: Crystal City VI-Bioanalytical Method Validation for Biomarkers [J].

Arnold, Mark E. ;

Booth, Brian ;

King, Lindsay ;

Ray, Chad .

AAPS JOURNAL, 2016, 18 (06) :1366-1372

[3] Workshop Report: Crystal City V-Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance [J].

Booth, Brian ;

Arnold, Mark E. ;

DeSilva, Binodh ;

Amaravadi, Lakshmi ;

Dudal, Sherri ;

Fluhler, Eric ;

Gorovits, Boris ;

Haidar, Sam H. ;

Kadavil, John ;

Lowes, Steve ;

Nicholson, Robert ;

Rock, Marie ;

Skelly, Michael ;

Stevenson, Lauren ;

Subramaniam, Sriram ;

Weiner, Russell ;

Woolf, Eric .

AAPS JOURNAL, 2015, 17 (02) :277-288

[4]

Duke-Margolis Center for Health Policy, PUBL WORKSH SCI REG

[5]

EU EMA, CONC PAP PRED BIOM B

[6] Addressing the challenges of biomarker calibration standards in ligand-binding assays: a European Bioanalysis Forum perspective [J].

Kunz, Ulrich ;

Goodman, Joanne ;

Loevgren, Ulf ;

Piironen, Timo ;

Elsby, Karen ;

Robinson, Paul ;

Pihl, Susanne ;

Versteilen, Amanda ;

Companjen, Arjen ;

Fjording, Marianne Scheel ;

Timmerman, Philip .

BIOANALYSIS, 2017, 9 (19) :1493-1508

[7]

Piccoli SP, CRITICAL PATH I POIN

[8] Feedback from the EBF - Focus Workshop: Bringing Assay Validation and Analysis of Biomarkers into Practice [J].

Timmerman, Philip ;

Fjording, Marianne Scheel ;

Allinson, John ;

Arfvidsson, Cecilia ;

Barroso, Begona ;

Diczfalusy, Ulf ;

Freeman, Adrian ;

Hickford, Elizabeth ;

Kandousi, Hamza ;

Katugampola, Sidath ;

Kunz, Ulrich ;

Nelson, Robert ;

Smeraglia, John .

BIOANALYSIS, 2017, 9 (09) :675-681

[9] Biomarker assay validation: are we having the right discussions? [J].

Timmerman, Philip .

BIOANALYSIS, 2016, 8 (22) :2299-2303

[10]

U.S. Food and Drug Administration, LIST QUAL BIOM

← 1 →