Stability of vaccines - bridging from stability data to continuous safety and efficacy throughout shelf life - an always reliable approach?
Stability studies are important tools to reliably ensure that efficacy and safety of medicinal products will remain unchanged from release of drug product until the end of shelf life. For complex medicinal products such as biological medicinal products, including vaccines, design and conduct of such studies requires particularly careful considerations in order to ensure that technical data resulting from stability studies are indeed indicative for unchanged clinical performance. Ideally, relevance of specifications controlled by stability studies as well as definition of shelf life should be justified by acceptable clinical data obtained with product at the end of the shelf life claimed.
Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Paul-Ehrlich-Strabe 51-59, 63225 Langen, Germany. pflmi@pei.de
Michael
M
Pfleiderer
D002986:Clinical Trials as Topic / Q000379:methods / Q000706:statistics & numerical data; D003627:Data Interpretation, Statistical; D004341:Drug Evaluation / Q000706:statistics & numerical data*; D004355:Drug Stability; D004356:Drug Storage; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D008954:Models, Biological; D011786:Quality Control; D015203:Reproducibility of Results; D016896:Treatment Outcome; D014612:Vaccines / Q000009:adverse effects / Q000493:pharmacokinetics / Q000592:standards / Q000627:therapeutic use
D014612:Vaccines