Preclinical Development – Chemical
2019 PharmSci 360
Predictive stability and QbD based method development approaches have found much success in accelerating pharmaceutical development. These approaches can be further enhanced through the application of artificial intelligence and machine learning to optimize process development and overall quality by design by integrating data across all platforms. Unique and unexpected outcomes from such applications are presented.
With the increasing advancement of breakthrough therapies there is an need for efficient and accelerated development strategies that ensure high quality products and enable continuous improvement. Among these strategies are the use of predictive stability modeling. These approaches are accepted by industry to rank order formulations, processes and packaging. It has also found success in regulatory submission to set initial shelf live for early development products and post-approval changes. Integrating formulation and process development data with the stability modeling provides additional advantages.