How do you set a retest period for a drug substance or shelf life for a drug product? How can extrapolation be applied to propose a retest period or shelf life for a drug product that extends beyond the period covered by real-time stability data? In this article, we outline how we can assist you with … Continued
Shelf-life is the period of time over which food maintains its safety and/or quality under reasonably foreseeable conditions of distribution, storage and use. The shelf-life begins from the time the food is produced and/or packed.
Development phase Accelerated stability tests provide a means of comparing alternative formula-dons, packaging materials, and/or manufacturing processes in short-term experiments. As soon as the final formulation and manufacturing process have been established, the manufacturer carries out a series of accelerated stability tests which will enable the stability of the drug product or medical device to … Continued