Clinical Studies

In-vivo clinical assessment of intradermal PK/PD profiles in healthy and disease subjects.

 

 

 

 

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.

 

Our Services

 

  • 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.

More information

To learn more about our innovative technology and its application, please visit our dedicated OFM website.

Contact Us

 

Learn more about OFM

Schedule a conversation with
our OFM Experts.

 

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