Following the launch of its initiative, "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach," FDA has been looking to process analytical technology (PAT) for improvements in process ...

Out-of-Pocket Costs for Tyrosine Kinase Inhibitors and Patient Outcomes in EGFR- and ALK-Positive Advanced Non–Small-Cell Lung Cancer Literature review identified 226 unique measures from 23 measure ...

The author outlines key considerations for carrying out a structured approach to monitoring process performance and ensuring product quality. Routine, ongoing assessment of process performance and ...