Advancing nonclinical innovation and safety in pharmaceutical testing

被引：9

作者：

Baker, Elizabeth J. ^{[1
]}

Beck, Nancy A. ^{[2
]}

Berg, Ellen L. ^{[3
]}

Clayton-Jeter, Helene D. ^{[4
]}

Chandrasekera, P. Charukeshi ^{[5
]}

Curley, J. Lowry ^{[6
]}

Donzanti, Bruce A. ^{[7
]}

Ewart, Lorna C. ^{[8
]}

Gunther, Jane M. ^{[9
]}

Kenna, J. Gerry ^{[10
]}

LeCluysell, Edward L. ^{[11
]}

Liebman, Michael N. ^{[12
]}

Pugh, Catherine L. ^{[13
]}

Watkins, Paul B. ^{[14
]}

Sullivan, Kristie M. ^{[1
]}

机构：

[1] Phys Comm Responsible Med, 5100 Wisconsin Ave NW,Ste 400, Washington, DC 20016 USA

[2] 226 New Mark Esplanade, Rockville, MD 20850 USA

[3] Eurofins DiscoverX, 310 Utah Ave, San Francisco, CA 94080 USA

[4] Boston Sci, 1455 Penn Ave NW 925, Washington, DC 20004 USA

[5] Canadian Ctr Alternat Anim Methods, 401 Sunset Ave,Biol Bldg,Suite 326, Windsor, ON N9B 3P4, Canada

[6] AxoSim Technol, 1441 Canal St,Suite 206, New Orleans, LA 70112 USA

[7] Genentech Inc, 350 DNA Way Mailstop 355c, San Francisco, CA 94080 USA

[8] AstraZeneca, IMED Biotech Unit, Drug Safety & Metab, 1 Francis Crick Ave, Cambridge CB2 0RE, England

[9] Nektar Therapeut, 455 Mission Bay Blvd South, San Francisco, CA 94158 USA

[10] Safer Med Trust, POB 122, Kingsbridge TQ7 9AX, England

[11] LifeNet Hlth, 1864 Concert Dr, Virginia Beach, VA 23453 USA

[12] IPQ Analyt, 231 Deepdale Dr, Kennett Sq, PA 19348 USA

[13] Hlth IT Now, 440 1st St NW 430, Washington, DC 20001 USA

[14] Univ N Carolina, Inst Drug Safety Sci, 301 Pharm Lane,CB 7355, Chapel Hill, NC 27599 USA

来源：

DRUG DISCOVERY TODAY | 2019年 / 24卷 / 02期

关键词：

TOXICITY;

D O I：

10.1016/j.drudis.2018.11.011

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Nonclinical tests are considered crucial for understanding the safety of investigational medicines. However, the effective translation from nonclinical to human application is limited and must be improved. Drug development stakeholders are working to advance human-based in vitro and in silicc methods that may be more predictive of human efficacy and safety in vivo because they enable scientists to model the direct interaction of drugs with human cells, tissues, and biological processes Here, we recommend test-neutral regulations; increased funding for development and integration of human-based approaches; support for existing initiatives that advance human-based approaches; evaluation of new approaches using human data; establishment of guidelines for procuring human cells and tissues for research; and additional training and educational opportunities in human-basec approaches,

引用

页码：624 / 628

页数：5

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