AAPS-FDA workshop white paper: Microdialysis principles, application and regulatory perspectives
(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)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/662938
- author
- organization
- publishing date
- 2007
- type
- 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
- LU publication?
- yes
- id
- 03ee7a83-1fd4-41d9-85a7-51a39a8b2cb2 (old id 662938)
- date added to LUP
- 2016-04-01 11:52:38
- date last changed
- 2022-04-28 21:23:04
@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}}, keywords = {{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}}, doi = {{10.1007/s11095-006-9206-z}}, volume = {{24}}, year = {{2007}}, }