The Handle and the Briefcase: Model Quality for Quality By Design

QbD is based on a fundamental understanding of process performance and product quality, which can be derived from first principles modeling methods. Model development and use routinely suffers from peer-to-peer variability that undermines the credibility of model-based evidence. In this talk we discuss Amgen’s approach to model quality and modeling lifecycle management to enable model-informed decisions and promote model-based filing activities. Several case studies will be presented.