Opportunities lie in providing training for companies to modernize their stability testing programs, ensuring compliance with updated ICH and global guidelines. This is crucial for avoiding delays and ...

The International Council for Harmonisation (ICH) on 17 April issued its long-awaited update of its Q1 guideline on stability testing of drug substances and drug products. The new guideline ...

ICH stability chambers with continuous monitoring for long-term, intermediate, and accelerated studies supporting FDA submissions and retailer qualification IRVINE ...

Advanced kinetic modeling (AKM) can accurately describe the complex behaviors of biologics, reducing risks from the developmental stage all the way through last-mile delivery. Importantly, regulators ...