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

Reference9 articles.

1. U.S. Department of Health and Human Services, FDA, Center for Drug Evaluation and Research. 2014. Guidance for industry community-acquired bacterial pneumonia: developing drugs for treatment. FDA, Silver Spring, MD. www.fda.gov/regulatory-information/search-fda-guidance-documents/community-acquired-pneumonia-developing-antimicrobial-drugs-treatment.

2. Azoulay-Dupuis E Vallee E Veber B Bedos JP Bauchet J Pocidalo JJ. 1992. In vivo efficacy of a new fluoroquinolone sparfloxacin against penicillin-susceptible and -resistant and multiresistant strains of Streptococcus pneumoniae in a mouse model of pneumonia. Antimicrob Agents Chemother 36:2698–2703. doi:10.1128/AAC.36.12.2698.

3. A Robust Pneumonia Model in Immunocompetent Rodents to Evaluate Antibacterial Efficacy against S. pneumoniae, H. influenzae, K. pneumoniae, P. aeruginosa or A. baumannii

4. A Non-Human Primate Model of Severe Pneumococcal Pneumonia

5. Mestas J Hughes C. 2004. Of mice and not men: differences between mouse and human immunology. J Immunol 172:2731–2738. doi:10.4049/jimmunol.172.5.2731.

Cited by 8 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Development and validation of a rabbit model of Pseudomonas aeruginosa non-ventilated pneumonia for preclinical drug development;Frontiers in Cellular and Infection Microbiology;2023-12-11

2. Therapeutic Bacteriophages for Gram-Negative Bacterial Infections in Animals and Humans;Pathogens and Immunity;2022-10-17

3. Variability of murine bacterial pneumonia models used to evaluate antimicrobial agents;Frontiers in Microbiology;2022-09-08

4. Expert workshop summary: Advancing toward a standardized murine model to evaluate treatments for antimicrobial resistance lung infections;Frontiers in Microbiology;2022-09-08

5. Dissemination of Gram-positive bacteria to the lung of newborn mice increases local IL-6 and TNFα levels in lethal bacteremia;Microbes and Infection;2022-09