Your questions - our approach

API testing

Which biochemical effects are caused by an API in the dermis?

Our approach: We investigate potential effects as well as any side effects of your API by

  • directly administering an unformulated API via OFM probes into the dermis
  • continuously sampling dermal interstitial fluid
  • analyzing a wide PD marker panel in the dermal interstitial fluid samples to provide a continuous PD profile for your API.

Is the API targeting the intended biochemical pathway in the dermis?

Our approach: We investigate the intended mechanism of action in-vivo in the dermis by

  • directly administering an unformulated API via OFM probes into the dermis
  • continuously sampling dermal interstitial fluid
  • analyzing a customized PD marker panel in the dermal interstitial fluid samples to provide a continuous PD profile for your API.

Which API concentration in the dermis achieves the intended therapeutic effect?

Our approach: We investigate the local dose-response relationship in-vivo in the dermis by

  • directly administering an unformulated API via OFM probes into the dermis
  • continuously sampling dermal interstitial fluid
  • analyzing a customized PD marker panel in the dermal interstitial fluid samples to provide dose-response information for your API.
  • applying different concentrations of the API to the dermis to determine
    • the relevant API concentration in the dermis that achieves the intended therapeutic effect.
    • potential local toxicity of the API.
Benefits

Your Benefits

  • 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 of your unformulated API in-vivo in the dermis.
  • No need to formulate the API.
  • Reduce your time and costs by reducing risk of failure in drug development.
  • Receive a highly resolved time profile of API action for up to 36 hours.
  • Identical trial set-up in preclinical and clinical experiments.
Contact
Download

Download the current folder on our dermal PK/PD services here.