Clinical Pharmacology – Chemical
End-to-End Hot Topic
Drug product development is a particularly costly and lengthy process. The growing availability of quantitative methods, coupled with advances in instrumentation, bioinformatics tools and software are shifting the ways drug discovery and drug development are accomplished. The application of mechanistic models such as physiologically based biopharmaceutics modeling (PBBM) is growing rapidly and is becoming an essential part for streamlining drug discovery and development. In this presentation, the FDA position on how mechanistic modeling and simulation (e.g., PBBM, PB-IVIVC/IVIVR) can be applied to accelerate drug product development focusing on the strategies for building a safe space towards regulatory flexibility in support of drug product quality will be discussed.