Fda Public Workshop Summary: Advancing Animal Models For Antibacterial Drug Development

James M Byrne,Ursula Waack,Edward A Weinstein,Abhay Joshi, Simone M Shurland,Dmitri Iarikov,Jürgen B Bulitta,Binh An Diep,Tina Guina,William W Hope,Matthew B Lawrenz,Alexander J Lepak,Brian M Luna,Lynn Miesel,Andrew J Phipps,Thomas J Walsh,William Weiss,Thushi Amini,John J Farley

ANTIMICROBIAL AGENTS AND CHEMOTHERAPY（2021）

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摘要

The U.S. Food and Drug Administration (FDA) hosted a public workshop entitled "Advancing Animal Models for Antibacterial Drug Development" on 5 March 2020. The workshop mainly focused on models of pneumonia caused by Pseudomonas aeruginosa and Acinetobacter baumannii. The program included discussions from academic investigators, industry, and U.S. government scientists. The potential use of mouse, rabbit, and pig models for antibacterial drug development was presented and discussed.

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关键词

FDA, animal models, antibacterial, antibiotics, drug development, humanized dose, pneumonia, regulatory, workshop

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