Considerations For Nonclinical Dermal Studies — Advancing To Phase 1

Dermal drug delivery approaches are gaining traction across various therapeutic areas, including the reformulation of existing medications. In many cases, enhancements to the delivery system can enable successful 505(b)(2) applications, potentially extending a drug's patent life for its sponsor or opening up marketing opportunities for companies developing dermal delivery for already marketed drugs. As the field advances, new medications are being specifically designed for dermal delivery, and innovative methods are continuously being tested for market viability. Dermal studies require specialized expertise, and minipigs are often used due to the physiological similarities between their skin and human skin. With decades of experience in dermal research, Altasciences is proud to have access to one of the largest herds of miniature swine in North America, including the most widely used minipig breeds for dermal studies.

In this issue, we will explore the nonclinical requirements for advancing a dermal program to Phase 1 clinical trials, outline strategies to address common challenges, and discuss key formulation considerations for dermal drug development.