From early First-In-Man studies, early clinical stage phase 0 or phase 1 studies, we investigate and compare local PK and PD profiles directly in the dermis to investigate bioavailability, penetration behaviour and release rates of topically, intravenously, orally or intraperitoneally applied drugs for up to 36hours using our dOFM or microdialysis. Clinical studies can be conducted in healthy or diseased subjects (psoriasis, dermatitis,…)
We investigate potential effects and any side effects of your drugs directly in the skin by applying a formulated drug via the intended route (e.g. subcutaneous, intravenous, oral, topical). We use OFM or microdialysis probes in the dermis and continuously sample dermal interstitial fluid. Samples are analyzed in our GLP certified lab for your drug concentration (PK) and for a wide PD marker panel.
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.
- Get temporal pharmacokinetic profiles for your drug in the dermis for up to 36 hours.
- In-vivo dose-response is measured directly in the dermis instead of surrogate parameters in blood.
- At the earliest possible stage in drug development you can demonstrate intended therapeutic effects and the intended mechanisms of action of your API in-vivo in the dermis.
- Identical trial set-up in preclinical, ex-vivo and clinical experiments.