Dermal

Sinclair Research has experience with all conventional routes of compound administration, including transdermal and dermal applications. Sinclair personnel are also experts in dermal toxicity testing, conducting GLP-compliant dermal and transdermal toxicology, safety, and drug metabolism and pharmacokinetic (DMPK) studies in an FDA-recommended model, the miniature swine, available from Sinclair Bioresources.

The Hanford miniature swine, which have white skin, are an appropriate model for dermal studies; these have been used for most of the 90-day GLP dermal toxicology studies performed at Sinclair. Sinclair has developed a white, hairless Yucatan miniature swine breed for dermal absorption, irritation, and photosensitivity studies. A sublineage of Sinclair miniature swine, Sinclair S-1, also have white skin and are smaller than either the Yucatan or Hanford breeds; they are appropriate models for dermal studies as well.

Services offered include:

  • Dermal Toxicity Testing
    • Acute, short-term (7- to 28-day), subchronic (90-day), or chronic exposure durations
    • Single or repeat dose, occluded or non-occluded administration site
  • Passive and active (iontophoretic) dermal/transdermal patch administration
  • Dermal evaluation of irritation and local tolerance
  • Phototoxicity model in miniature swine
  • Standard toxicology endpoints – clinical observations, clinical pathology, ECG, ophthalmology, histopathology
  • Dermal drug metabolism and pharmacokinetic (DMPK) studies
  • Pharmacokinetics and toxicokinetics for dermal/transdermal routes of administration
  • Cross-contamination prevention – custom equipment for dermal studies
  • Custom large animal enclosures for dermal studies, utilizing stainless steel full barriers
  • Dose preparation
  • Full-thickness and partial thickness dermal wounds, skin barrier interruption by scarification and tape stripping of the stratum corneum

Other Skin Models

  • Skin allergy, atopy
  • Psoriasis
  • Depigmentation
  • Iontophoresis
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