Erratum to: Open Flow Microperfusion as a Dermal Pharmacokinetic Approach to Evaluate Topical Bioequivalence
| Autor: | Sam G. Raney, Thomas R. Pieber, Katrin I. Tiffner, Manfred Bodenlenz, Isadore Kanfer, Thomas Birngruber, Christian Dragatin, Denise Schimek, Gerd Schwagerle, Frank Sinner, Reingard Raml, Thomas Augustin |
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| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Adult
Male Short Communication Microdialysis Pharmacology toxicology MEDLINE Skin Cream Acyclovir 02 engineering and technology Bioequivalence Pharmacology Administration Cutaneous 030226 pharmacology & pharmacy Antiviral Agents 03 medical and health sciences 0302 clinical medicine Pharmacokinetics Medicine Humans Pharmacology (medical) business.industry Published Erratum 021001 nanoscience & nanotechnology Open flow Therapeutic Equivalency Area Under Curve Female Erratum 0210 nano-technology business |
| Zdroj: | Clinical Pharmacokinetics |
| Popis: | Background The availability of generic topical dermatological drug products is constrained by the limited methods established to assess topical bioequivalence (BE). A novel cutaneous pharmacokinetic approach, dermal open-flow microperfusion (dOFM), can continuously assess the rate and extent to which a topical drug becomes available in the dermis, to compare in vivo dermal bioavailability (BA) and support BE evaluations for topical products. Objective To evaluate whether dOFM is an accurate, sensitive, and reproducible in vivo method to characterize the intradermal BA of acyclovir from 5 % acyclovir creams, comparing a reference (R) product either to itself or to a different test (T) product. Methods In a single-center clinical study, R or T products were applied to six randomized treatment sites on the skin of 20 healthy human subjects. Two dOFM probes were inserted in each treatment site to monitor the intradermal acyclovir concentration for 36 h. Comparative BA (of R vs. R and T vs. R) was evaluated based on conventional BE criteria for pharmacokinetic endpoints (area under the curve and maximum plasma concentration) where the 90 % confidence interval of the geometric mean ratio between the T and R falls within 0.80–1.25. Results The positive control products (R vs. R) were accurately and reproducibly confirmed to be bioequivalent, while the negative control products (T vs. R) were sensitively discriminated not to be bioequivalent. Conclusions dOFM accurately, sensitively, and reproducibly characterized the dermal BA in a manner that can support BE evaluations for topical acyclovir 5 % creams in a study with n = 40 (20 subjects in this study). |
| Databáze: | OpenAIRE |
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