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OLYMPUS DIGITAL CAMERA
OLYMPUS DIGITAL CAMERA
OLYMPUS DIGITAL CAMERA
OLYMPUS DIGITAL CAMERA

Local application for aspired systemic availability

Although absorption via the skin is highly dependent on the physicochemical properties of the drug substance, the properties of the device also play an important role. Unfortunately, prediction of in-vivo performance from in-vitro data is often disappointing! Thus, testing in humans remains the only really reliable method for assessing formulation properties.

Experience matters

For more than 10 years we have repeatedly performed all relevant types of clinical trials with Transdermal Therapeutic Systems:

  • Pilot studies for establishing in-vitro-/in-vivo correlations
  • Bioequivalence trials
  • Local tolerability and patch adhesion trials
  • Dermal irritation / sensitisation trials

Differing requirements: EU vs US

Currently, the new European guidelines result in a strong requirement of experience and knowhow to adequately realise the studies in practice. So far, the methods and procedures are not entirely defined. However, SocraTec R&D has already established methods and standard operating procedures which reflect the new requirements and the experience of many years with such trials.

 

 

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