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.
The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF, talks about spray drying for drying amorphous solid dispersions and Raman spectroscopy’s role as a quantitative analytical tool.
Aleksandra Zuraw, senior veterinary pathologist at Charles River, discusses how chain of custody, good laboratory practice, quality control, and validation are applied to digital pathology data used in drug development.