(325f) Role of Models for Implementation of Design Space: An FDA View

Defining a multivariate design space is one of the key aspects of a Quality by Design (QbD) based drug development. Enhanced understanding gained from following a QbD approach could be leveraged to support control strategies such as Real Time Release Testing (RTRT). Mathematical models can be utilized throughout drug product development: beginning with risk assessment to identify potential parameters that may affect the finished product quality, mapping out and implementing a design space for process operation and finally to monitor/control the process during commercial manufacturing. The aim of this presentation is to illustrate, using relevant examples, various modeling approaches that can be used for the development and implementation of design space and for RTRT and to discuss some regulatory considerations for maintenance/management of these models throughout the product life cycle.