Vol 59: Stabil Program Challenges & Solutions in Drug CMC Development

In this audiocast, we delve into the critical challenge of ensuring the stability of drug products throughout their lifecycle in the complex drug development process. This blog article explores the intricacies of stability testing and offers solutions to its challenges. From the limited availability of stability-indicating methods to the complex formulation and excipient interactions and manufacturing process variability, this audiocast provides insights into adopting advanced analytical techniques, predictive modeling, quality management systems, and collaboration to establish robust stability programs. By overcoming these challenges, drug developers can ensure the delivery of safe and effective medications to patients while complying with regulatory requirements