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 ...

Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and ...

Dublin, Nov. 20, 2023 (GLOBE NEWSWIRE) -- The "Statistical Elements of Implementing ICH Quality Guidelines" training has been added to ResearchAndMarkets.com's offering. This training is designed for ...

Although stability testing programs for small-molecule drugs and biologics are often perceived as similar, stability programs for biologics are far more complex. The purpose of stability testing ...

As compounds become more complex in nature and biological ingredients are more widely used, stability testing approaches must follow suit and provide flexibility for developers. According to market ...

This 2-day seminar explores the unique challenges facing quality functions of pharmaceutical and biotechnology companies. Attendees will learn practical implementation solutions as well as best ...

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 ...