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 ...

-- Carry out appropriate stability studies and manage stability samples and facilities -- Design stability studies that are suitable for global marketing -- Increase the likelihood of studies ...

Sufficient stability studies show a drug product meets regulatory requirements, therefore ensuring the drug reaches the patients who rely on it. While every drug molecule is unique and brings its own ...

Experts have hailed the proposed draft Schedule M guidelines placing significant emphasis on stability testing compared to the existing Schedule M. This marks a commendable stride in aligning with ...

Stability studies are a cornerstone of pharmaceutical quality. They ensure that a pharmaceutical product will maintain its efficacy and safety for its established shelf life to protect patient safety.