Insights on Dermal Toxicology Studies for FDA Filings
Essentials for Successful Dermal Safety Testing
Altasciences’ team of preclinical research experts, including toxicologists, veterinarians, and technicians, have extensive experience and a solid understanding of the challenges specific to dermal research. In this eBook, we answer critical questions and highlight key considerations to help you advance your dermal program from discovery through clinical trials to proof-of-concept, and beyond.
You’ll learn about:
• important factors to consider before starting your dermal research program;
• questions you can expect our preclinical research team to ask you;
• the data required for regulatory agencies; and
• available FDA pathways and how to choose the right one for your molecule.
Ready to begin? Altasciences’ preclinical research team can design and conduct studies that reliably and quickly provide you with the data you need, from initial efficacy work through IND-enabling programs and regulatory submissions. We can develop new dermal models, validate existing ones, and perform GLP and non-GLP toxicology studies to support both 505(b)(2) and new chemical entity regulatory filings. Get started today!