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Ex-Vivo and In-Vivo OFM Studies for Topical Drugs

Unique de-risking and proof-of-mechanism studies for dermal active ingredients

Ex-Vivo Studies

The kinetics of topical drugs are investigated using fresh/frozen tissue from animals and human donors. The data are important to support preclinical drug development regarding lead selection, formulation screening, and optimization.

  • Models: human skin from plastic surgery, porcine skin
  • Study duration: up to 48 hours
  • Time resolution: 5 min to hours
  • Application sites: up to 30 sites with 3 OFM probes each
  • Material: preclinical OFM material

In-Vivo Studies

We conduct studies to investigate the permeation, stability, and pharmacokinetics/pharmacodynamics (PK/PD) of a topical active pharmaceutical ingredient under development.

OFM studies in live animals with active blood and lymph circulation provide important information such as the distinction between permeation and clearance kinetics. The unique capability of OFM technology enables the study of large molecular compounds and immune cells for a better understanding of the mechanism of action (MOA) of the drug candidate under investigation. As a result, the in-vivo OFM approach has proven its value in predicting clinical efficacy and supports the right development decisions before entering the clinical phase.

  • Models: pig, rodent
  • Study duration: up to 48 hours
  • Time resolution: 5 min to hours
  • Application areas: up to 14 application areas with 3 OFM samples each
  • Material: preclinical OFM material
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