Stability of Vaccines – Bridging From Stability Data to Continuous Safety and Efficacy Throughout Shelf Life – An Always Reliable Approach?
This article, published in Biologicals, discusses why stability studies are important tools to reliably ensure that the efficacy and safety of medicinal products remain unchanged from release of drug product until the end of shelf life. The author explains that, for complex medicinal products such as biological medicinal products, including vaccines, the design and conduct of such studies requires particularly careful considerations in order to ensure that the technical data resulting from these studies are indeed indicative for unchanged clinical performance. ABSTRACT ONLY. (Learn how users in developing countries can gain free access to journal articles.)
Author(s): Pfleiderer M
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Citation: Pfleiderer M. Stability of Vaccines – Bridging From Stability Data to Continuous Safety and Efficacy Throughout Shelf Life – An Always Reliable Approach? Biologicals. 2009;37(6):364-368.