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Antimicrobial Agents and Chemotherapy, February 2002, p. 586-589, Vol. 46, No. 2
0066-4804/01/$04.00+0     DOI: 10.1128/AAC.46.2.586-589.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.

Levofloxacin Penetration into Epithelial Lining Fluid as Determined by Population Pharmacokinetic Modeling and Monte Carlo Simulation

G. L. Drusano,1* S. L. Preston,2 M. H. Gotfried,2,3 L. H. Danziger,3 and K. A. Rodvold3

Division of Clinical Pharmacology, Clinical Research Institute, Albany Medical College, Albany, New York;,1 University of Arizona, School of Medicine, Tucson, Arizona;,2 University of Illinois, College of Pharmacy, Chicago, Illinois3

Received 5 January 2001/ Returned for modification 21 August 2001/ Accepted 25 October 2001

Levofloxacin was administered orally to steady state to volunteers randomly in doses of 500 and 750 mg. Plasma and epithelial lining fluid (ELF) samples were obtained at 4, 12, and 24 h after the final dose. All data were comodeled in a population pharmacokinetic analysis employing BigNPEM. Penetration was evaluated from the population mean parameter vector values and from the results of a 1,000-subject Monte Carlo simulation. Evaluation from the population mean values demonstrated a penetration ratio (ELF/plasma) of 1.16. The Monte Carlo simulation provided a measure of dispersion, demonstrating a mean ratio of 3.18, with a median of 1.43 and a 95% confidence interval of 0.14 to 19.1. Population analysis with Monte Carlo simulation provides the best and least-biased estimate of penetration. It also demonstrates clearly that we can expect differences in penetration between patients. This analysis did not deal with inflammation, as it was performed in volunteers. The influence of lung pathology on penetration needs to be examined.

* Corresponding author. Mailing address: Division of Clinical Pharmacology, Clinical Research Institute, Albany Medical College, Albany, NY 12208. Phone: (518) 262-6330. Fax: (518) 262-6333. E-mail: GLDRUSANO{at}AOL.COM.

Antimicrobial Agents and Chemotherapy, February 2002, p. 586-589, Vol. 46, No. 2
0066-4804/01/$04.00+0     DOI: 10.1128/AAC.46.2.586-589.2002
Copyright © 2002, American Society for Microbiology. All Rights Reserved.



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