Pharmacodynamics of levofloxacin: a new paradigm for early clinical trials

SL Preston, GL Drusano, AL Berman, CL Fowler… - Jama, 1998 - jamanetwork.com
Context.—One purpose of early clinical trials is to establish the appropriate dose of an
antibiotic for phase 3 trials. Development of a relationship between the ratio of drug
exposure to organism minimum inhibitory concentration (MIC) and therapeutic response
early in the development process would allow an optimal choice of dose to maximize
response. Objective.—To prospectively quantitate the relationship between plasma levels of
levofloxacin and successful clinical and/or microbiological outcomes and occurrence of …