Antibacterial Drug Development: Challenges, Recent Developments, and Future Considerations

被引：44

作者：

Nambiar, S. ^{[1
]}

Laessig, K. ^{[1
]}

Toerner, J. ^{[2
]}

Farley, J. ^{[2
]}

Cox, E. ^{[2
]}

机构：

[1] US FDA, Div Antiinfect Prod, Silver Spring, MD 20993 USA

[2] US FDA, Off Antimicrobial Prod, Silver Spring, MD USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2014年 / 96卷 / 02期

关键词：

PNEUMONIA;

D O I：

10.1038/clpt.2014.116

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

A decline in antibacterial drug development coupled with emerging bacterial resistance has resulted in limited treatment options. One of the challenges facing antibacterial drug development is appropriate clinical trial designs. Noninferiority trials are appropriate to study new antibacterial drugs for the treatment of serious diseases; superiority trials can be challenging and cannot be the only acceptable trial design to study antibacterial drugs. Our efforts must continue to make new therapies available to meet patient needs.

引用

页码：147 / 149

页数：3

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