Sinclair Research is a Center of Excellence for Dermal Research with a broad range of capabilities, expertise, and best practices. Sinclair personnel are experts in dermal toxicity testing, conducting GLP-compliant dermal and transdermal toxicology and safety studies. In addition to toxicology, Sinclair supports a wide range of drug metabolism and pharmacokinetic (DMPK) studies and efficacy studies, including wound healing and inflammatory studies in an FDA-recommended model, the miniature swine. The Sinclair research team has experience with all conventional routes of compound administration, including transdermal (passive and active), dermal applications (ointments, creams, lotions) and dermal applications specialized devices.
We are used to working with all commonly used research lineages of miniature swine, namely, the Hanford, Gottingen, Sinclair, and Yucatan. The Hanford miniature swine, which have white skin and available from Sinclair Bioresources, have been used for over 20 years as a model for dermal studies. Sinclair has developed a white, hairless Yucatan miniature swine breed for dermal absorption, irritation, and photosensitivity studies. The Sinclair miniature swine have also been selected for white skin and are smaller than either the Yucatan or Hanford lineages; they are appropriate models for dermal studies as well.
In addition to miniature swine, Sinclair offers dermal studies in a number of other species, including mice, rats, rabbits, guinea pigs, dogs, and non-human primates.
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, sensitization, and local tolerance
- Phototoxicity and photoallergy models
- 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
- A dedicated dermal study team for scoring (Draize, Magnusson and Kligman grading) and photography
- Custom large animal enclosures for dermal studies, utilizing stainless steel full barriers
- Dose preparation
Other Skin Models
- Full-thickness and partial thickness dermal wounds, skin barrier interruption by scarification and tape stripping of the stratum corneum
- Skin allergy, atopy, depigmentation