Presentation Description: PBPK models, informed by the prior knowledge of human anatomy, physiology, genetics and its associated variability, provides a robust framework to integrate physiochemical properties of drug substance and formulation quality attributes, thereby enabling understanding of complex interplay of drug/drug products and human physiology. Application of these (semi)-mechanistic models in the field of locally acting drug products is particularly interesting wherein drug concentrations at the local (action) site (hardly accessible via traditional experimentation) can be related to the therapeutic performance. This talk will discuss the considerations/key parameters needed to develop and verify/validate a mechanistic dermal absorption model (as implemented in Simcyp Simulator V19) capable of explaining observed in vitro and in vivo permeation of drugs across skin from topical applied drug products. The talk will highlight a case study discussing the application of PBPK model, verified with in vitro skin permeation, to predict in vivo exposure of topically applied drug products.
Upon completion, the participant will be able to list data requirements in developing and verifying/validating a physiologically based pharmacokinetic framework for modelling in vitro skin permeation of topical/transdermal products.
Upon completion, the participant will be able to understand the utility of PBPK models in identifying critical product quality attributes of topical/transdermal drug products influencing skin permeation.
Upon completion, the participant will be able to appreciate the utility of verified PBPK models in predicting in vivo dermal exposure of topically applied drug products.