Abstract:
:Traditionally, plasma or serum drug concentrations have been used for the assessment of bioavailability and bioequivalence. Since in the majority of cases the site of drug action is in the tissue rather than the blood, the use of corresponding free, unbound concentrations in the tissue is a much more meaningful approach. This can become especially important for topical drug administrations, where locally active drug concentrations can significantly exceed free concentrations in plasma. The ability to measure these free concentrations at the site of drug action over time makes microdialysis a very valuable tool for the assessment of bioavailability and bioequivalence. This has been recognized by industry and regulatory authorities, resulting in a recommendation of the microdialysis technique as a tool for bioequivalence determination of topical dermatologic products. The aim of this article is to provide an updated review of the microdialysis technique, its applications in skin and soft tissues, and the resulting impact on clinical drug development.
journal_name
J Clin Pharmacoljournal_title
Journal of clinical pharmacologyauthors
Schmidt S,Banks R,Kumar V,Rand KH,Derendorf Hdoi
10.1177/0091270007312152subject
Has Abstractpub_date
2008-03-01 00:00:00pages
351-64issue
3eissn
0091-2700issn
1552-4604pii
48/3/351journal_volume
48pub_type
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