PBPK Models to Aid the Development of Generic Dermatological Products

The Food and Drug Administration (FDA) is seeking to promote further enhancements to PBPK modeling and simulation tools to improve their predictive power and expand their capabilities. The goals of this research include incorporating formulation attributes, developing an in silico in vitro permeation testing module, and generating new experimental data to support these goals. The FDA is looking for applicants to conduct research in these areas to aid the development of generic dermatological products. • Incorporation of formulation attributes such as viscosity and Q1/Q2 information to improve predictive power • Development of an in silico in vitro permeation testing module to support formulation development and selection • Generation of new experimental data to support the other goals • Incorporation of novel approaches in accounting for excipient effects on skin permeation • Enhancements of skin physiology models to include skin metabolism and stratum corneum morphology