Applications of Physiologically Based Biopharmaceutics Modeling and Simulation in Oral Drug Development

While biopharmaceutics models are widely used in the pharmaceutical industry to accelerate internal decision making for the design and selection of clinical and market formulations, regulatory applications to enable early access to new drugs have been limited so far. The establishment of a framework to be able to utilize information from biopharmaceutics models in a regulatory context could support acceleration of patient access to new medicines without compromise for the patients. Using a combination of advanced bio-relevant in vitro systems and in silico Physiologically Based Biopharmaceutics Modeling (PBBM), in combination with agile and information-rich clinical study designs will enable rapid development and change management of drug products with optimal performance. These tools can be applied, through development, commercialization and post-approval, to drug substance property and formulation selection, optimization, change management and scale-up. Biopharmaceutics models can be applied to support accelerated patient access to innovative medicines by reducing the overall time required to develop a robust high-quality drug product with the desired clinical performance. Industry believes that a deep understanding of fundamental biopharmaceutics properties of the active substance and product and the application of biopharmaceutics models are powerful tools in the acceleration of development programs. The use of Biopharmaceutics models may also lead to a decreased need for in vivo data avoiding exposure of healthy volunteers during the execution of BE studies and proceed more confidently with formulation changes later in the clinical plan, avoiding the need for relative bioavailability or BE studies on the critical path. In this session, the current trend of using PBBM in the industry will be presented and discussed with the case studies.