Evaluate the dermal pharmacokinetics bioavailability, ADME, and toxicokinetics of your new dermatology drug, biologic or device in any species. Our dermal models range from normal, to diseased, knockout and transgenic models with single, multiple or infusion/slow release dose administration of small and large molecules, stem cells, metals, stem cells, immunotherapeutics, nanoparticles and devices.
We feature rapid study initiation and report preparation to meet sponsor deadlines or milestones. We comply with FDA, OECD, and ICH guidelines. Our capabilities in Pharmacokinetics include early exploratory, investigative, or screening studies, cassette dosing studies, juvenile studies, disease model studies, and formal studies that support regulatory submission. We specialize in unusual and customized studies. We also provide matrix and method validation.
Dermal pharmacokinetics research is key to selecting early compounds or chemical structures for further assessment as well as assessing candidates for advancement into clinical trials. CBI offers a variety of preclinical dermal pharmacokinetic, pharmacodynamic and biodistribution study capabilities. Our assessment and analysis modalities are fine-tuned to meet the specific requirements demanded in each targeted area of dermatologic pharmacokinetic investigation.
Dermal studies may be done in most species including rodents, small animals, dogs, pigs, and rabbits. Study duration may run from hours to months. Pharmacodynamic endpoints such as local irritation, Draize scores, qPCR, Silouette photography, Doppler blood flow, histology, immunohistochemistry, histomorphometry may be evaluated during the pharmacokinetic study.
Pharmacokinetic studies may be performed in normal skin or in diseased skin. Dermal disease models may include: burns and wound, diabetes, psoriasis, dermal ectoparasitism, infection, and custom models.
Dermal Routes of Administration
- Single, multiple or continuous infusion dosing
- Intra epidermal
- Implant or device
- Additional routes upon request
- Topical creams, ointments, gels, drops
- Stem cells and autologus cells
- Gene therapy and regenerative medicine
- Implant and inserts and combination
- Microspheres and particles
- Additional formulations, customized and radiolabeled study available
- Knockout and transgenic rodents
- Rabbits, guinea pigs, hamsters
- Swine, minipigs, Durocs
Pharmacokinetics in Dermal Disease Models
- Burns and Wounds
- Custom models
- Application sites
- Method validation and bioanalytical report preparation
- Metabolic and pharmacodynamic studies
- Complex or non-standard routes of administration