Stability studies are a critical step in the drug development process and are required prior to having a marketed, commercial product. Stability studies are performed throughout the drug development cycle for various reasons.
To begin, stability studies are conducted to support the formulation development and the safety and efficacy claims of investigational new drugs. At registration, stability data is obtained to evaluate the shelf-life of the drug product in the intended packaging. Finally, post-approval studies are conducted to ensure quality of the production or potential changes to the product.
The experts at Agilent have the historical experience to complete your stability studies according to your desired program. We are dedicated to being experts in nucleic acid chemistry and we utilize this knowledge to ensure success for your oligo API and drug product stability studies.
Agilent stability protocols are designed to support global registration of your drug product.
 • Stability programs to support APIs and final drug product
• Qualified stability chambers for all ICH conditions, including photo-stability
• GLP studies with dose formulation analysis
• Statistical analysis and data trending
|