Challenges and Solutions for Clinical Development of New Antibacterial Agents: Results of a Survey among Pharmaceutical Industry Professionals

被引：23

作者：

Bettiol, Esther ^{[1
,2
,3
]}

Wetherington, Jeffrey D. ^{[4
]}

Schmitt, Nicola ^{[5
]}

Harbarth, Stephan ^{[1
,2
,3
]}

机构：

[1] Geneva Univ Hosp, Infect Control Program, Geneva, Switzerland

[2] Geneva Univ Hosp, Div Infect Dis, Geneva, Switzerland

[3] Fac Med, Geneva, Switzerland

[4] GlaxoSmithKline, Quantitat Sci, Philadelphia, PA USA

[5] AstraZeneca, Biometr & Informat Sci, Macclesfield, Cheshire, England

来源：

ANTIMICROBIAL AGENTS AND CHEMOTHERAPY | 2015年 / 59卷 / 07期

关键词：

ANTIMICROBIAL RESISTANCE; REGULATORY FRAMEWORK; DRUG DEVELOPMENT; EVOLUTION; PROGRESS; UPDATE;

D O I：

10.1128/AAC.00638-15

中图分类号：

Q93 [微生物学];

学科分类号：

071005 ; 100705 ;

摘要：

As the number of antibacterial medicines in the pipeline remains low, we anonymously surveyed pharmaceutical industry professionals on challenges and solutions for clinical development of these agents. Challenges were reported primarily as financial and regulatory. For multidrug-resistant organisms, there are needs for rapid diagnostic tests, new regulatory guidance, and adaptation of endpoints/trial designs. Regulators and public/private initiatives are addressing these challenges to help ensure that proposed solutions have the support of all involved stakeholders.

引用

页码：3695 / 3699

页数：5

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