Data Set and BE Evaluation Results

The data set from the clinical dOFM BE study [2] included data on the dermal PK of acyclovir delivered topically from the R and T products parameterized as PK endpoint data (area under the dermal concentration-time curve (AUC) and peak/maximum dermal concentration (C_max) values), as well as demographic data, data on each subject’s skin barrier properties (TEWL, skin conductance), skin temperature, dOFM probe-related data (probe depths), and data derived from methodological monitoring (glucose-loss, recovered lactate and sample mass) (Table ​(Table11).

Data set of the acyclovir dOFM BE study

¹37 h of sampling: One hour baseline sampling followed by 36 h of post-dose sampling in 4 h- intervals (10 samples per probe).

The results of the BE evaluation of this study have been published by Bodenlenz et al. [2]. The relative bioavailability of R vs. R and T vs. R has been evaluated based on the conventional BE PK endpoints, AUC and C_max in the dermis, where the criterion for establishing the BE of a T to an R is that the 90% confidence interval of the geometric mean ratio between the T and R falls within 0.80 and 1.25. In brief, the positive control products (R vs. R) were accurately and reproducibly confirmed to be bioequivalent [AUC0–36 h (0.86–1.18) and C_max (0.86–1.21)], while the negative control products (T vs. R) were sensitively discriminated not to be bioequivalent for both parameters [AUC0–36 h (0.69–1.05) and C_max (0.61–1.02)].