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Bodenlenz, M; Dragatin, C; Hoefferer, C; Birngruber, T; Priedl, J; Feichtner, F; Schaller, R; Aigner, B; Korsatko, S; Pieber, TR; Sinner, F.
Certified dOFM sampling devices provide access to target tissue in pharmaceutical trials.
Biomed Tech (Berl). 2013; 58 Suppl 1(12):
Doi: 10.1515/bmt-2013-4133
Web of Science
PubMed
FullText
FullText_MUG
- Leading authors Med Uni Graz
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Sinner Frank Michael
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Weiss Manfred
- Co-authors Med Uni Graz
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Birngruber Thomas
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Feichtner Franz
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Korsatko Stefan
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Pieber Thomas
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Sadoghi Birgit
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- Abstract:
- Clinical testing of dermatological drugs requires access to the site of drug action within the dermis. Conventional methods such as skin biopsies are rather invasive and provide limited data on the kinetics and dynamics of drugs. We present minimally invasive dermal sampling probes and a wearable pump for continuous sampling from the dermis. These dermal open flow microperfusion (dOFM) devices comply with international medical device guidelines (CE certified) and have demonstrated applicability and tolerability in clinical trials. dOFM is likely to become an invaluable tool for clinical bioequivalence trials prior to market release of generic drugs.
- Find related publications in this database (Keywords)
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open flow microperfusion
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medical devices
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wearable multichannel pump
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human trials
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preclinical trials