Clinical studies

Clinical studies range from investigator initiated studies and first-in-human studies to clinical stage phase 0 or phase 1 studies. We monitor local PK/PD directly in the dermis for up to 36 hours using dOFM or microdialysis. Clinical studies can be conducted in healthy volunteers or patients (psoriasis, acne, dermatitis). Clinical trials are conducted according to ICH-GCP standards at the Clinical Trials Unit of the Medical University of Graz.

We investigate intended effects of your drug and potential side effects directly in the skin by applying a formulated drug via the intended route (e.g. subcutaneous, oral, topical). We use dOFM or microdialysis probes in the dermis and continuously sample dermal interstitial fluid. 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 studies.

Samples are analyzed in our GLP certified lab for drug´s concentration and for a wide PD marker panel.

Your benefits

• Spatial and 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.
• Very early in your drug development process you can demonstrate intended therapeutic effects and the intended mechanisms of action for your API in-vivo in the dermis.
• Optimized clinical study design based on identical dOFM set-up in ex-vivo, preclinical, and clinical studies.
   

Preclinical animal studies

Our animal models include healthy and disease models (psoriasis, chronic inflammation) in awake or anaesthetized rodents and pigs. Preclinical in-vivo studies are performed in cooperation with the Institute for Biomedical Research at the Medical University of Graz.

We investigate intended effects of your drug and potential side effects directly in the skin by applying a formulated drug via the intended route (e.g. subcutaneous, oral, topical). We use dOFM or microdialysis probes in the dermis and continuously sample dermal interstitial fluid. 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 studies.

Complementary techniques include tape-stripping and specialized in-vivo biopsies to obtain cross-sectional dermal PK profiles.

Your benefits

• Spatial and 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.
• Very early in your drug development process you can demonstrate intended therapeutic effects and the intended mechanisms of action for your API in-vivo in the dermis.
• No need to formulate the API for dose-response studies.
• Reduced costs by minimizing the risk of failure with in-vivo PK/PD data at the earliest possible stage in drug development.
• Identical dOFM set-up in preclinical and clinical experiments ensures highly translatable results.
   

Ex-vivo studies

We use freshly excised human and porcine skin samples to investigate and compare skin penetration and release rates of topically applied APls. Excised skin studies are ideal to simultaneously test the penetration rates of many different formulations. The lack of blood circulation generates higher drug concentrations even for less effective formulations and also allows for multiple drug applications on one subject. Ex-vivo studies are cost effective and compliant with the 3R strategy to reduce animal testing.

IVRT

We also offer in-vitro drug release testing with Franz Diffusion Cells in combination with GLP compliant bioanalytical analyses.