Preclinical predictors of clinical safety: Opportunities for improvement

被引：29

作者：

Sistare, F. D. ^{[1
]}

DeGeorge, J. J. ^{[1
]}

机构：

[1] Merck & Co Inc, Safety Assessment, West Point, PA USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2007年 / 82卷 / 02期

关键词：

D O I：

10.1038/sj.clpt.6100243

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Toxicology studies in animals are required by regulatory authorities worldwide to provide assurances that clinical testing of pharmaceutical candidates can be conducted safely. 1 Safety concerns from animal studies account for over 20% of attritions from drug development. 2 As discordance between humans and animals is expected, two goals of safe and efficient drug development must be (1) to improve the human relevance of animal testing with new models and technologies, and (2) to advance quickly to clinical testing armed with improved safety biomarker tools.

引用

页码：210 / 214

页数：5

共 27 条

[1] Myocardial infarction redefined -: A consensus Document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction [J].

Alpert, JS ;

Antman, E ;

Apple, F ;

Armstrong, PW ;

Bassand, JP ;

de Luna, AB ;

Beller, G ;

Breithardt, G ;

Chaitman, BR ;

Clemmensen, P ;

Falk, E ;

Fishbein, MC ;

Galvani, M ;

Garson, A ;

Grines, C ;

Hamm, C ;

Jaffe, A ;

Katus, H ;

Kjekshus, J ;

Klein, W ;

Klootwijk, P ;

Lenfant, C ;

Levy, D ;

Levy, RI ;

Luepker, R ;

Marcus, F ;

Näslund, U ;

Ohman, M ;

Pahlm, O ;

Poole-Wilson, P ;

Popp, R ;

Alto, P ;

Pyörälä, K ;

Ravkilde, J ;

Rehnquist, N ;

Roberts, W ;

Roberts, R ;

Roelandt, J ;

Rydén, L ;

Sans, S ;

Simoons, ML ;

Thygesen, K ;

Tunstall-Pedoe, H ;

Underwood, R ;

Uretsky, BF ;

Van de Werf, F ;

Voipio-Pulkki, LM ;

Wagner, G ;

Wallentin, L ;

Wijns, W .

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2000, 36 (03) :959-969

[2] Identification of putative gene-based markers of renal toxicity [J].

Amin, RA ;

Vickers, AE ;

Sistare, F ;

Thompson, KL ;

Roman, RJ ;

Lawton, M ;

Kramer, J ;

Hamadeh, HK ;

Collins, J ;

Grissom, S ;

Bennett, L ;

Tucker, CJ ;

Wild, S ;

Kind, C ;

Oreffo, V ;

Davis, JW ;

Curtiss, S ;

Naciff, JM ;

Cunningham, M ;

Tennant, R ;

Stevens, J ;

Car, B ;

Bertram, TA ;

Afsharil, CA .

ENVIRONMENTAL HEALTH PERSPECTIVES, 2004, 112 (04) :465-479

[3]

[Anonymous], 2006, GUID IND INV REV EXP

[4]

[Anonymous], 2004, INN STAGN CHALL OPP

[5]

[Anonymous], GUID IND PHARM DAT S

[6] Nontraditional approaches to first-in-human studies to increase efficiency of drug development, will microdose studies make a significant impact? [J].

Boyd, R. A. ;

Lalonde, R. L. .

CLINICAL PHARMACOLOGY & THERAPEUTICS, 2007, 81 (01) :24-26

[7] CARDIAC-SPECIFIC TROPONIN-I RADIOIMMUNOASSAY IN THE DIAGNOSIS OF ACUTE MYOCARDIAL-INFARCTION [J].

CUMMINS, B ;

AUCKLAND, ML ;

CUMMINS, P .

AMERICAN HEART JOURNAL, 1987, 113 (06) :1333-1344

[8] MICE DEFICIENT FOR P53 ARE DEVELOPMENTALLY NORMAL BUT SUSCEPTIBLE TO SPONTANEOUS TUMORS [J].

DONEHOWER, LA ;

HARVEY, M ;

SLAGLE, BL ;

MCARTHUR, MJ ;

MONTGOMERY, CA ;

BUTEL, JS ;

BRADLEY, A .

NATURE, 1992, 356 (6366) :215-221

[9] Cytochrome P450 and xenobiotic receptor humanized mice [J].

Gonzalez, FJ ;

Yu, AM .

ANNUAL REVIEW OF PHARMACOLOGY AND TOXICOLOGY, 2006, 46 :41-64

[10] Mechanism of action of the nongenotoxic peroxisome proliferators:: Role of che peroxisome proliferator-activated receptor α [J].

Gonzalez, FJ ;

Peters, JM ;

Cattley, RC .

JOURNAL OF THE NATIONAL CANCER INSTITUTE, 1998, 90 (22) :1702-1709

← 1 2 3 →