Pharmaceutical Research

, Volume 24, Issue 5, pp 1014–1025

AAPS-FDA Workshop White Paper: Microdialysis Principles, Application and Regulatory Perspectives

Authors

    • Division of BioequivalenceOffice of Generic Drugs, Food and Drug Administration
  • Markus Müller
    • Department of Clinical PharmacologyMedical University Vienna
  • Edward D. Bashaw
    • Division of Clinical Pharmacology III, Office of Clinical PharmacologyUS-FDA
  • Eva Benfeldt
    • Department of DermatologyUniversity of Copenhagen
  • Jan Bolinder
    • Deptartment of MedicineKarolinska University Hospital Huddinge, Karolinska Institutet
  • Ross Bullock
    • Medical College of Virginia
  • Peter M. Bungay
    • Division of Bioengineering and Physical ScienceOffice of Research Services, NIH
  • Elizabeth C. M. DeLange
    • LACDR
  • Hartmut Derendorf
    • Department of PharmaceuticsUniversity of Florida
  • William F. Elmquist
    • Department of PharmaceuticsUniversity of Minnesota
  • Margareta Hammarlund-Udenaes
    • Department of Pharmaceutical BiosciencesUppsala University
  • Christian Joukhadar
    • Department of Clinical PharmacologyMedical University Vienna
  • Dean L. KelloggJr.
    • Department of MedicineThe University of Texas Health Science Center at San Antonio
  • Craig E. Lunte
    • Department of ChemistryUniversity of Kansas
  • Carl Henrik Nordstrom
    • Department of NeurosurgeryUniversity Hospital
  • Hans Rollema
    • Department NeurosciencePfizer Global Research
  • Ronald J. Sawchuk
    • Department of PharmaceuticsUniversity of Minnesota
  • Belinda W. Y. Cheung
    • Department of PharmaceuticsUniversity of Minnesota
  • Vinod P. Shah
    • Pharmaceutical Federation
  • Lars Stahle
    • Astra Zeneca
  • Urban Ungerstedt
    • Department of Physiology and PharmacologyKarolinska Institutet
  • Devin F. Welty
    • Pharmacokinetics and Drug MetabolismAllergan Inc.
  • Helen Yeo
    • Departnment of Drug Metabolism and Pharmacokinetics
Research Paper

DOI: 10.1007/s11095-006-9206-z

Cite this article as:
Chaurasia, C.S., Müller, M., Bashaw, E.D. et al. Pharm Res (2007) 24: 1014. doi:10.1007/s11095-006-9206-z

Abstract

Many decisions in drug development and medical practice are based on measuring blood concentrations of endogenous and exogenous molecules. Yet most biochemical and pharmacological events take place in the tissues. Also, most drugs with few notable exceptions exert their effects not within the bloodstream, but in defined target tissues into which drugs have to distribute from the central compartment. Assessing tissue drug chemistry has, thus, for long been viewed as a more rational way to provide clinically meaningful data rather than gaining information from blood samples. More specifically, it is often the extracellular (interstitial) tissue space that is most closely related to the site of action (biophase) of the drug. Currently microdialysis (μD) is the only tool available that explicitly provides data on the extracellular space. Although μD as a preclinical and clinical tool has been available for two decades, there is still uncertainty about the use of μD in drug research and development, both from a methodological and a regulatory point of view. In an attempt to reduce this uncertainty and to provide an overview of the principles and applications of μD in preclinical and clinical settings, an AAPS-FDA workshop took place in November 2005 in Nashville, TN, USA. Stakeholders from academia, industry and regulatory agencies presented their views on μD as a tool in drug research and development.

Key words

clinical pharmacologymicrodialysisrecoveryregulatory aspects

Copyright information

© Springer Science+Business Media, LLC 2007