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 ...

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 ...

Maximizing and validating the stability of a drug is critical throughout its life cycle, beginning in the development phase of an active pharmaceutical ingredient (API), continuing through the final ...

While stability testing for small molecule drugs is well established, its counterpart for biologicals is still evolving. Dozens of techniques have emerged for characterizing proteins, ranging from the ...

This is an intensive two-day masterclass that will help you get a deeper insight into: Analytical Quality by Design (QbD) and Lifecycle Management The Accelerated Stability Assessment Programme (ASAP ...

-- 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 ...

Selecting the right stability partner is crucial for accelerating your product’s journey to market while ensuring its safety and compliance. A partner with expertise in evolving regulatory ...

An up-to-date and well-established residential course designed to: Provide delegates with a detailed appraisal of the rationale and techniques associated with the stability testing of pharmaceuticals ...