Stability Optimization,Navigating the maze of container/closure systems
Stability optimization of a drug product is commonly only considered during the drug development phase. The decision to package a product in a vial or a syringe is typically made in the early phases of drug development and testing and is based on allowing for ultimate flexibility for the clinical site. The stability of the drug product with the container is tested throughout the drug development life cycle but, again, is typically only performed on a container that allows the ultimate flexibility in dosing and administration at the clinical site.
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Journal:
CONTRACT -PHARMA--NOV/DECEMBER-2007
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