Regulatory Stability Considerations for Biological Products
Stability studies are conducted to establish the shelf life and to support shipping and handling conditions for biological drug products.
The regulatory requirement for stability studies to support commercial drug product shelf life is clearly defined by regulatory guidelines. However, these guidelines do not specifically address requirements for clinical drug products. In the absence of sufficient regulatory and technical expertise, it can be challenging to design stability studies that will support a successful regulatory submission to FDA, EMA and other regulatory agencies around the world.
In this publication, you will get insight into regulatory considerations and designs of stability studies, including in-use (compatibility) studies, supporting clinical trial initiation and supporting establishment of shelf lifes.