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Review

Importance of Relating Efficacy Measures to Unbound Drug Concentrations for Anti-Infective Agents

Daniel Gonzalez, Stephan Schmidt, Hartmut Derendorf
Daniel Gonzalez
Department of Pharmaceutics, College of Pharmacy, University of Florida, Gainesville, Florida, USAa
Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USAb
Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, USAc
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Stephan Schmidt
Department of Pharmaceutics, Center for Pharmacometrics and Systems Pharmacology, College of Pharmacy, University of Florida, Lake Nona, Florida, USAd
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Hartmut Derendorf
Department of Pharmaceutics, College of Pharmacy, University of Florida, Gainesville, Florida, USAa
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  • For correspondence: hartmut@ufl.edu
DOI: 10.1128/CMR.00092-12
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SUMMARY

For the optimization of dosing regimens of anti-infective agents, it is imperative to have a good understanding of pharmacokinetics (PK) and pharmacodynamics (PD). Whenever possible, drug efficacy needs to be related to unbound concentrations at the site of action. For anti-infective drugs, the infection site is typically located outside plasma, and a drug must diffuse through capillary membranes to reach its target. Disease- and drug-related factors can contribute to differential tissue distribution. As a result, the assumption that the plasma concentration of drugs represents a suitable surrogate of tissue concentrations may lead to erroneous conclusions. Quantifying drug exposure in tissues represents an opportunity to relate the pharmacologically active concentrations to an observed pharmacodynamic parameter, such as the MIC. Selection of an appropriate specimen to sample and the advantages and limitations of the available sampling techniques require careful consideration. Ultimately, the goal will be to assess the appropriateness of a drug and dosing regimen for a specific pathogen and infection.

  • Copyright © 2013, American Society for Microbiology. All Rights Reserved.
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Importance of Relating Efficacy Measures to Unbound Drug Concentrations for Anti-Infective Agents
Daniel Gonzalez, Stephan Schmidt, Hartmut Derendorf
Clinical Microbiology Reviews Apr 2013, 26 (2) 274-288; DOI: 10.1128/CMR.00092-12

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Importance of Relating Efficacy Measures to Unbound Drug Concentrations for Anti-Infective Agents
Daniel Gonzalez, Stephan Schmidt, Hartmut Derendorf
Clinical Microbiology Reviews Apr 2013, 26 (2) 274-288; DOI: 10.1128/CMR.00092-12
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    • SUMMARY
    • INTRODUCTION
    • METHODS AVAILABLE TO MEASURE PROTEIN BINDING AND TISSUE DISTRIBUTION
    • APPROACHES FOR ESTABLISHING PK/PD RELATIONSHIPS
    • PK/PD RELATIONSHIPS
    • CONCLUSIONS
    • ACKNOWLEDGMENTS
    • REFERENCES
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