Assessing Animal Models of Bacterial Pneumonia Used in Investigational New Drug Applications for the Treatment of Bacterial Pneumonia-Reference-Cited by-同舟云学术

Assessing Animal Models of Bacterial Pneumonia Used in Investigational New Drug Applications for the Treatment of Bacterial Pneumonia

Published:2020-04-21 Issue:5 Volume:64 Page:
ISSN:0066-4804
Container-title:Antimicrobial Agents and Chemotherapy
language:en
Short-container-title:Antimicrob Agents Chemother

Author:

Waack Ursula¹²,Weinstein Edward A.¹,Farley John J.¹

Affiliation:

1. U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of New Drugs, Office of Infectious Diseases, Silver Spring, Maryland, USA

2. Oak Ridge Institute of Science and Education, Oak Ridge, Tennessee, USA

Abstract

Animal models of bacterial infection have been widely used to explore the in vivo activity of antibacterial drugs. These data are often submitted to the U.S. Food and Drug Administration to support human use in an investigational new drug application (IND). To better understand the range and scientific use of animal models in regulatory submissions, a database was created surveying recent pneumonia models submitted as part of IND application packages. The IND studies were compared to animal models of bacterial pneumonia published in the scientific literature over the same period of time.

Funder

Oak Ridge Associated Universities

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

Link

https://journals.asm.org/doi/pdf/10.1128/AAC.02242-19

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