Scientific Publications by FDA Staff

Antimicrob Agents Chemother 2020 Apr 21;64(5):e02242-19

Assessing animal models of bacterial pneumonia used in investigational new drug applications for the treatment of bacterial pneumonia.

Waack U, Weinstein EA, Farley JJ

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 US 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. In this review, we analyze the key experimental design elements, such as animal species, immune status, pathogens selected, and route of administration, and study endpoints.