• Siladitya Ray Chaudhuri Ph.D.
  • Sam G. Raney Ph.D.

Proposal Description:

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Skin is the largest organ of the human body. The basic structure is a semi–permeable membrane that can potentially function as an entry point for a host of therapeutic substances aimed at both local and systemic delivery for diseases of the skin. This has resulted in dermatological drug products being a big industry (upwards of USD $30 billion). However, many of the active pharmaceutical ingredients (APIs) and excipients used in a typical formulation may interact among themselves or adversely with the skin or other internal physiological systems. Hence, a mechanistic understanding of drug release from the formulation, partitioning, and disposition kinetics of the API (drug substance) in the skin and the behavior of the final drug product are key to development of a successful dermatological drug product. The development, regulatory approval, and subsequent commercialization of pharmaceutical drug products applied to the skin involve scientific knowledge from several disciplines. It requires a thorough understanding of the following functional areas:
•Skin physiology, anatomy, and physicochemical/microstructural features
•Skin diseases, their pathology, and implications for topical treatments
•Understanding and controlling the permeation of APIs into and through the skin
•In vitro assessment of different biopharmaceutical characteristics and their extrapolation in vivo
•Key aspects of successful topical dermal formulations
•Complex formulations and delivery modalities
•Pre-clinical development and regulatory aspects
•Clinical development and regulatory aspects
•Regulatory view on bioequivalence
•Modeling and simulation of the behavior of the drug substance and the product
•Bioanalytical aspects of measuring drug concentration in the skin

For Day Two's agenda, visit Dermatological Drug Products Day Two Agenda

Sub Sessions