Services

Preclinical Studies

In-vivo preclinical assessment of intradermal PK/PD profiles in healthy and disease animal models.

Preclinical 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.

Our Services

  • Spatial and temporal pharmacokinetic profiles for your drug in the dermis for up to 72 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.

 

Learn more about Open Flow Microperfusion (OFM)

Services

We analyze low volume samples from all biological matrices to determine PK/PD profiles and to support your biomarker research.

Fast and efficient PK based bioequivalence testing of topical generics.

We offer a wide range of specialized biostatistical services to manage all aspects of your study from design to data analysis.

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