We use in-vitro test procedures to ensure the reliability of quantitative dermal sampling. Before any in-vivo or ex-vivo study we assess compound stability and compound absorption to enable reliable data interpretation in the subsequent studies.
Ex-vivo testing in excised skin samples
We use healthy and diseased skin samples (human, procine) for our ex-vivo PK studies which are controlled for temperature and humidity. We investigate skin penetration and release rates of topically applied APIs. Human excised skin is provided by the Biobank at the Medical University of Graz.
Preclinical in-vivo studies
We perform preclinical in-vivo PK and PD studies using our OFM technique or conventional microdialysis. We investigate how the API/drug is absorbed and metabolized when introduced to the body by different application routes (e.g. transdermal, intravenous, intraperitoneal).
Dermal in-vivo studies in rodents and pigs are carried out in awake animals or in anaesthetized animals for up to 12 hours. Preclinical in-vivo studies are performed in cooperation with the Institute for Biomedical Research at the Medical University of Graz.
Clinical in-vivo studies
OFM is only minimally invasive and enables prolonged dermal ISF sampling for up to 36 hours in patients or healthy volunteers. Multiple probes per application site allow for an efficient study design which delivers a large amount of reliable data while using only a relatively small number of subjects in PK/PD and bioavailability/bioequivalence studies.
Clinical trials are conducted according to ICH-GCP standards at the Clinical Research Centre of the Medical University of Graz.