This executive summary focuses on dose-flexible manufacturing strategies and their role in drug
development. Dose flexibility is increasingly important for early clinical studies, particularly in areas such as
pediatric medicines and oncology. However, flexible dosing strategies are often neglected or not prioritized
early in development. This presentation will focus on technical strategies that can help anticipate appropriate
timing for implementation and how to do so cost effectively while adhering to required timelines.
This week on PharmTech, Merck diversified its pipeline, USP emphasizes supply chain security, AI systems are examined, and speakers preview their presentations at CPHI Milan and AAPS PharmSci 360.
Capsugel's Bram Baert and Sandrine Picco argue that chasing zero nitrite in pharmaceutical excipients is often impractical and costly. They recommend setting scientifically justified, risk-based limits and consistently staying below them.
Ron Scarboro, Azurity Pharmaceuticals, claims drug reformulation that removes patient barriers must preserve efficacy, urging early cross-functional team alignment.
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.