Biomarker assay validation: are we having the right discussions?

被引:6
作者
Timmerman, Philip [1 ]
机构
[1] Janssen R&D, Beerse, Belgium
关键词
comedication; interference testing; method validation; selectivity; DRUG DEVELOPMENT; RECOMMENDATIONS;
D O I
10.4155/bio-2016-0142
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
引用
收藏
页码:2299 / 2303
页数:5
相关论文
共 11 条
[1]   Analytical Validation Considerations of Multiplex Mass-Spectrometry-Based Proteomic Platforms for Measuring Protein Biomarkers [J].
Boja, Emily S. ;
Fehniger, Thomas E. ;
Baker, Mark S. ;
Marko-Varga, Gyorgy ;
Rodriguez, Henry .
JOURNAL OF PROTEOME RESEARCH, 2014, 13 (12) :5325-5332
[2]   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
[3]  
EMA, 2001, EMEACHMPEWP192217200
[4]  
FDA, 2013, DRAFT GUID BIOAN MET
[5]  
Hougton R, 2012, BIOANALYSIS, V4, P2439, DOI [10.4155/BIO.12.197, 10.4155/bio.12.197]
[6]   Recommendations for adaptation and validation of commercial kits for biomarker quantification in drug development [J].
Khan, Masood U. ;
Bowsher, Ronald R. ;
Cameron, Mark ;
Devanarayan, Viswanath ;
Keller, Steve ;
King, Lindsay ;
Lee, Jean ;
Morimoto, Alyssa ;
Rhyne, Paul ;
Stephen, Laurie ;
Wu, Yuling ;
Wyant, Timothy ;
Lachno, D. Richard .
BIOANALYSIS, 2015, 7 (02) :229-242
[7]   Fit-for-purpose method development and validation for successful biomarker measurement [J].
Lee, JW ;
Devanarayan, V ;
Barrett, YC ;
Weiner, R ;
Allinson, J ;
Fountain, S ;
Keller, S ;
Weinryb, I ;
Green, M ;
Duan, L ;
Rogers, JA ;
Millham, R ;
O'Brien, PJ ;
Sailstad, J ;
Khan, M ;
Ray, C ;
Wagner, JA .
PHARMACEUTICAL RESEARCH, 2006, 23 (02) :312-328
[8]   Practical Guidance for Implementing Predictive Biomarkers into Early Phase Clinical Studies [J].
Marton, Matthew J. ;
Weiner, Russell .
BIOMED RESEARCH INTERNATIONAL, 2013, 2013
[9]  
Perrett D., 2015, 8 EBF OP S BARC SPAI
[10]  
Timmerman P, 2012, BIOANALYSIS, V4, P1883, DOI [10.4155/BIO.12.164, 10.4155/bio.12.164]