International – ICH plans model-informed drug development guideline in 3-4 years
The International Council for Harmonisation (ICH) released a widely anticipated timetable detailing its plans to issue general guidance on model-informed drug development (MIDD) approaches...
International – Mechanical, material stresses affect drug quality
Making medicines is a stressful business, literally. Bioprocessing technologies, cleaning agents, and even packaging can create stresses that impact drug quality. Understanding these stresses...