Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Bodenlenz, M; Augustin, T; Birngruber, T; Tiffner, KI; Boulgaropoulos, B; Schwingenschuh, S; Raney, SG; Rantou, E; Sinner, F.
Variability of Skin Pharmacokinetic Data: Insights from a Topical Bioequivalence Study Using Dermal Open Flow Microperfusion.
Pharm Res. 2020; 37(10):204-204
Doi: 10.1007/s11095-020-02920-x
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- Führende Autor*innen der Med Uni Graz
- Sinner Frank Michael
- Weiss Manfred
- Co-Autor*innen der Med Uni Graz
- Birngruber Thomas
- Boulgaropoulos Beate
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- Abstract:
- Dermal open flow microperfusion (dOFM) has previously demonstrated its utility to assess the bioequivalence (BE) of topical drug products in a clinical study. We aimed to characterize the sources of variability in the dermal pharmacokinetic data from that study. Exploratory statistical analyses were performed with multivariate data from a clinical dOFM-study in 20 healthy adults evaluating the BE, or lack thereof, of Austrian test (T) and U.S. reference (R) acyclovir cream, 5% products. The overall variability of logAUC values (CV: 39% for R and 45% for T) was dominated by inter-subject variability (R: 82%, T: 91%) which correlated best with the subject's skin conductance. Intra-subject variability was 18% (R) and 9% (T) of the overall variability; skin treatment sites or methodological factors did not significantly contribute to that variability. Inter-subject variability was the major component of overall variability for acyclovir, and treatment site location did not significantly influence intra-subject variability. These results support a dOFM BE study design with T and R products assessed simultaneously on the same subject, where T and R treatment sites do not necessarily need to be next to each other. Localized variation in skin microstructure may be primarily responsible for intra-subject variability.
- Find related publications in this database (Keywords)
- Topical bioequivalence
- inter
- and intra-subject variability
- dermal open flow microperfusion
- microdialysis
- acyclovir
- skin pharmacokinetics