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.
News|Articles|December 21, 2006
US District Judge's Order Granting Preliminary Injunction in RxUSA Wholesale, et al, v. FDA
Author(s)Pharmaceutical Technology Editors
US District Court for the Eastern District of New York Judge Joanna Seybert's Dec. 11, 2006 Order granting a preliminary injunction in RxUSA Wholesale, et al, v. FDA, barring FDA from enforcing some drug pedigree rules.
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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.
FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
Xiaoling Li, University of the Pacific, discusses how 3D-printed tablets combine multiple APIs and release profiles, scale out instead of up, and use layer-by-layer scanning.
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.
Structural modifications can improve peptide stability, solubility, and absorption to enable effective oral delivery.
Continuous overall equipment effectiveness can be used to pinpoint hidden downtime and process bottlenecks in real time.
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