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AAPS-FDA workshop white paper: Microdialysis principles, application and regulatory perspectives

Chaurasia, Chandra S.; Mueller, Markus; Bashaw, Edward D.; Benfeldt, Eva; Bolinder, Jan; Bullock, Ross; Bungay, Peter M.; DeLange, Elizabeth C. M.; Derendorf, Hartmut and Elmquist, William F., et al. (2007) In Pharmaceutical Research 24(5). p.1014-1025
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... (More)
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 (mu D) is the only tool available that explicitly provides data on the extracellular space. Although mu D as a preclinical and clinical tool has been available for two decades, there is still uncertainty about the use of mu D 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 mu D 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 mu D as a tool in drug research and development. (Less)
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Contribution to journal
publication status
published
subject
keywords
microdialysis, clinical pharmacology, regulatory aspects, recovery
in
Pharmaceutical Research
volume
24
issue
5
pages
1014 - 1025
publisher
Springer
external identifiers
  • wos:000246112300019
  • scopus:34247618897
ISSN
1573-904X
DOI
10.1007/s11095-006-9206-z
language
English
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yes
id
03ee7a83-1fd4-41d9-85a7-51a39a8b2cb2 (old id 662938)
date added to LUP
2007-12-06 09:48:14
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2017-11-05 03:34:07
@article{03ee7a83-1fd4-41d9-85a7-51a39a8b2cb2,
  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 (mu D) is the only tool available that explicitly provides data on the extracellular space. Although mu D as a preclinical and clinical tool has been available for two decades, there is still uncertainty about the use of mu D 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 mu D 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 mu D as a tool in drug research and development.},
  author       = {Chaurasia, Chandra S. and Mueller, Markus and Bashaw, Edward D. and Benfeldt, Eva and Bolinder, Jan and Bullock, Ross and Bungay, Peter M. and DeLange, Elizabeth C. M. and Derendorf, Hartmut and Elmquist, William F. and Hammarlund-Udenaes, Margareta and Joukhadar, Christian and Kellogg, Dean L., Jr. and Lunte, Craig E. and Nordström, Carl-Henrik and Rollema, Hans and Sawchuk, Ronald J. and Cheung, Belinda W. Y. and Shah, Vinod P. and Stahle, Lars and Ungerstedt, Urban and Welty, Devin F. and Yeo, Helen},
  issn         = {1573-904X},
  keyword      = {microdialysis,clinical pharmacology,regulatory aspects,recovery},
  language     = {eng},
  number       = {5},
  pages        = {1014--1025},
  publisher    = {Springer},
  series       = {Pharmaceutical Research},
  title        = {AAPS-FDA workshop white paper: Microdialysis principles, application and regulatory perspectives},
  url          = {http://dx.doi.org/10.1007/s11095-006-9206-z},
  volume       = {24},
  year         = {2007},
}