Toxicity Testing in the 21st Century: A View from the Pharmaceutical Industry

被引：77
作者：
MacDonald, James S. [1 ]
Robertson, Richard T. [2 ]
机构：
[1] Chrysalis Pharma Consulting, Chester, NJ 07930 USA
[2] Bristol Myers Squibb Co, Res & Dev, Princeton, NJ 08540 USA
来源：
TOXICOLOGICAL SCIENCES | 2009年 / 110卷 / 01期
关键词：
COVALENT BINDING; ACYL GLUCURONIDES; DRUG WITHDRAWALS; UNITED-STATES; DISCOVERY;
D O I：
10.1093/toxsci/kfp088
中图分类号：
R99 [毒物学（毒理学）];
学科分类号：
100405 ;
摘要：
[No abstract available]
引用
收藏
页码：40 / 46
页数：7
相关论文
共 23 条
[1]   Toxicity Testing in the 21st Century: Bringing the Vision to Life [J].
Andersen, Melvin E. ;
Krewski, Daniel .
TOXICOLOGICAL SCIENCES, 2009, 107 (02) :324-330
[2]   Development of an in vitro screening model for the biosynthesis of acyl glucuronide metabolites and the assessment of their reactivity toward human serum albumin [J].
Bolze, S ;
Bromet, N ;
Gay-Feutry, C ;
Massiere, F ;
Boulieu, R ;
Hulot, T .
DRUG METABOLISM AND DISPOSITION, 2002, 30 (04) :404-413
[3]   Dynamic Proteomics of Individual Cancer Cells in Response to a Drug [J].
Cohen, A. A. ;
Geva-Zatorsky, N. ;
Eden, E. ;
Frenkel-Morgenstern, M. ;
Issaeva, I. ;
Sigal, A. ;
Milo, R. ;
Cohen-Saidon, C. ;
Liron, Y. ;
Kam, Z. ;
Cohen, L. ;
Danon, T. ;
Perzov, N. ;
Alon, U. .
SCIENCE, 2008, 322 (5907) :1511-1516
[4]   Human carcinogenic risk evaluation: An alternative approach to the two-year rodent bioassay [J].
Cohen, SM .
TOXICOLOGICAL SCIENCES, 2004, 80 (02) :225-229
[5]   Alternative models for carcinogenicity testing [J].
Cohen, SM ;
Robinson, D ;
MacDonald, J .
TOXICOLOGICAL SCIENCES, 2001, 64 (01) :14-19
[6]   Role of benoxaprofen and flunoxaprofen acyl glucuronides in covalent binding to rat plasma and liver proteins in vivo [J].
Dong, JQ ;
Liu, JH ;
Smith, PC .
BIOCHEMICAL PHARMACOLOGY, 2005, 70 (06) :937-948
[7]   Drug-protein adducts: An industry perspective on minimizing the potential for drug bioactivation in drug discovery and development [J].
Evans, DC ;
Watt, AP ;
Nicoll-Griffith, DA ;
Baillie, TA .
CHEMICAL RESEARCH IN TOXICOLOGY, 2004, 17 (01) :3-16
[8]  
*FDA, 2004, FDA CRIT PATH IN INN
[9]   Safety-related regulatory actions for biologicals approved in the United States and the European Union [J].
Giezen, Thijs J. ;
Mantel-Teeuwisse, Aukje K. ;
Straus, Sabine M. J. M. ;
Schellekens, Huub ;
Leufkens, Hubert G. M. ;
Egberts, Antoine C. G. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2008, 300 (16) :1887-1896
[10]   The application of discovery toxicology and pathology towards the design of safer pharmaceutical lead candidates [J].
Kramer, Jeffrey A. ;
Sagartz, John E. ;
Morris, Dale L. .
NATURE REVIEWS DRUG DISCOVERY, 2007, 6 (08) :636-649
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