Abstract
Over the past two decades, the quinolones have been the class of anti-infective agent for which the most pharmacodynamics relationships have been elucidated. Relationships for clinical and microbiological outcomes have been developed for patients with Hospital-acquired and Community-acquired infections. Advances in the use of Monte Carlo simulation have allowed the adequacy of dose choice for specific pathogen MIC distributions to be calculated.
For the first time, other pathogens have had pharmacodynamics principles applied to therapy. This has been particularly true for the therapy of tuberculosis, both in the clinic and also with the use of preclinical tools to elucidate optimal therapy.
The therapy of select agents, such as Bacillus anthracis (anthrax) and Yersinia pestis (plague), can never be validated in man. Therefore, use of pharmacodynamics principles have become a mainstay for the design of animal studies for the “Two Animal Rule,” which permit the issuance of a claim for an indication for these select agents by the FDA.
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Drusano, G.L., Heine, H.S., Louie, A. (2014). Clinical Pharmacodynamics of Quinolones. In: Vinks, A., Derendorf, H., Mouton, J. (eds) Fundamentals of Antimicrobial Pharmacokinetics and Pharmacodynamics. Springer, New York, NY. https://doi.org/10.1007/978-0-387-75613-4_13
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