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 ...
Pharmaceutical companies in the US are requesting additional information on how to conduct stability testing for both new and existing drugs in response to the International Council for ...
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 ...
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 ...
ICH stability chambers with continuous monitoring for long-term, intermediate, and accelerated studies supporting FDA submissions and retailer qualification IRVINE ...
The laboratory provides certificate of analysis (COA) testing, heavy metal analysis by ICP-MS, microbiology testing per USP and , preservative efficacy testing, stability studies under ICH guidelines, ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results