The presentation will discuss challenges associated with utilizing drug characterization and in-silico (model) based approaches to complement in vitro evidence by mitigating the risk of potential product failure modes, thereby accelerating the progression from the bench to bedside. Case studies successfully utilizing in-silico approaches for complex drug product development will be discussed, with an emphasis on specific approaches utilized to overcome common challenges.
Learning Objectives:
Upon completion, the attendees will:
1. Identify the areas in which new in vitro analytical and statistical methods can contribute to the preclinical development of complex products and support regulatory assessments of equivalence.
Upon completion, the attendees will:
Describe how in vitro testing and in-silico modeling for demonstrating complex product equivalence should be conducted and evaluated
Upon completion, the attendees will:
Solve scientific challenges with assessing critical quality attributes of complex products and with developing new analytical methods to elucidate the physicochemical, structural, and performance characteristics of complex products, to improve their advancement to the clinic.
