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.
Shubhajit Paul, a senior research fellow in Boehringer Ingelheim’s Department of Material Analytical Sciences, spoke with PharmTech at AAPS PharmSci 360 to explain how tabletability prediction can be improved for roller-compacted formulations.
This week on PharmTech.com, experts discussed E&L suitability standards, rare disease treatment development, sourcing ingredient suppliers, the use of AI in quality control, and more.
Mitigating nitrosamine risk requires assessing each product individually and chasing zero nitrite in pharmaceutical excipients is often impractical and costly.
In October, FDA reorganized rare disease development around a fit-for-purpose framework and a new pathway for individualized gene editing. Regulators in Europe and the UK set out long-term plans for clinical trials, AI, and moving away from animal testing.
Clinical, manufacturing, safety, and commercial teams all lean on shared data. They need to agree on who publishes each data product, who can use it, and what evidence goes with it.