There are many reasons to consider the 505(b)(2) approval pathway when developing new therapeutic topical and transdermal products that utilize known active pharmaceutical ingredients.While Tioga Research is focused exclusively on supporting clients interested in the research and early development of topical
We are proud to spotlight a recent publication in Pharmaceutical Research, co-authored by Dr. John M. Newsam, former CEO of Tioga Research. This perspective article presents a rigorous overview of how predictive tools are transforming the development of topical drug products.
Developing a topical drug product — whether for dermatological, transdermal, or cosmetic use — is a multifaceted process. It involves more than mixing an active ingredient into a cream or gel. Success depends on a deep understanding of skin biology, excipient
