Animal pharmacokinetics/pharmacodynamics (PK/PD) infection models for clinical development of antibacterial drugs: lessons from selected cases

Author:

Moore Jason N1,Poon Lucas12,Pahwa Sonia1,Bensman Timothy1,Wei Xiaohui (Tracey)1,Danielsen Zhixia Yan1,Jang Seong13

Affiliation:

1. Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration , 10903 New Hampshire Ave, Silver Spring, MD 20993 , USA

2. Department of Medicine, Uniformed Services University of the Health Sciences , 4301 Jones Bridge Rd, Bethesda, MD 20814 , USA

3. Elevar Therapeutics , 2755 E Cottonwood Pkwy #540, Salt Lake City, UT 84121 , USA

Abstract

Abstract In the wake of emerging antimicrobial resistance, antibacterial drug development has become more critical. At the same time, development of antibacterial drugs targeting specific pathogens or resistance phenotypes that may have low prevalence presents challenges because it is difficult to conduct large, randomized controlled trials for such drugs. Animal models have increasingly supported clinical development of antibacterials; however, more work is needed to optimize the design and application of these animal models to ensure clear and actionable translation to further human investigation. This review discusses recent case studies of animal infection models used to support antibacterial drug development in order to illuminate considerations for future development of novel antibacterial drugs.

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology,Microbiology (medical)

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