کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2034500 | 1072020 | 2009 | 6 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Maintenance of vaccine stability through annual stability and comparability studies
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کلمات کلیدی
موضوعات مرتبط
علوم زیستی و بیوفناوری
بیوشیمی، ژنتیک و زیست شناسی مولکولی
بیوشیمی، ژنتیک و زیست شناسی مولکولی (عمومی)
پیش نمایش صفحه اول مقاله
![عکس صفحه اول مقاله: Maintenance of vaccine stability through annual stability and comparability studies Maintenance of vaccine stability through annual stability and comparability studies](/preview/png/2034500.png)
چکیده انگلیسی
Evaluation of vaccine stability does not end with licensure of the product. An annual stability program helps assure continued quality of product throughout the dating period, while comparability studies are performed after a process or facilities change in order to demonstrate that the change has not impacted the stability characteristics of the product. Careful attention to the design and analysis of post licensure studies helps mitigate the risk of missing a meaningful shift in the degradation rate of a vaccine, as well as the possibility of incorrectly earmarking a stability shift when the product remains acceptable.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Biologicals - Volume 37, Issue 6, November 2009, Pages 397–402
Journal: Biologicals - Volume 37, Issue 6, November 2009, Pages 397–402
نویسندگان
Timothy L. Schofield,