dOFM provides time resolved PK/PD data in preclinical and clinical studies


We support your drug development program from early stage candidate screening to late-stage clinical studies. Using our proprietary dOFM technology we focus on local PK and PD profiles directly in the dermis. The same dOFM study set-up is used to compare formulations and substances ex-vivo and in-vivo thus ensuring the relevance of preclinical data for further clinical drug development.

Clinical studies

 

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.

Your benefits:

  • 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.
     

 

Preclinical tests

 

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 24hours using our dOFM or microdialysis.

Complementary techiques include tape stripping and specialized in-vivo biospies to obtain cross sectional PK profiles.

Our animal models include 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.

Your benefits:

  • Get spatial and temporal pharmacokinetic profiles for your drug in the dermis.
  • Reduce the risk of failure by access to in-vivo PK/PD data at the earliest possible stage in drug development.
  • Reduce your time and costs by reducing risk of failure in drug development.
  • 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.
  • No need to formulate the API.
  • Identical trial set-up in preclinical and clinical experiments.
     

 

Ex vivo tests

 

We investigate and compare skin penetration and release rates of topically applied APls in excised skin samples (human, porcine).

 


 

IVRT

 

We provide IVRT method development and test including bioanalytical analysis GLP compliant.

 

Reference project

 

Project: Secukinumab

In a recently published study, dOFM was successfully used for continuous sampling and quantification of a therapeutic antibody (secukinumab) in healthy and diseased skin.

 

Contact Us

 

Please reach out and we will answer
your questions, react to your ideas and
deal with your requirements straight away.

 

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