کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
10852994 | 1072058 | 2005 | 4 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Regulatory considerations for marker vaccines and diagnostic tests in the U.S.
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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)
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چکیده انگلیسی
The regulatory requirements for licensure of marker vaccines and diagnostic test kits are not different from that for other products. There are several mechanisms for vaccine approval, some more rapid than others, but only a few that could apply to these products. Generally, the platforms that might support marker vaccines and companion diagnostic kits are those based on genetic engineering or protein manipulation. If the product is derived from the application of biotechnology, then additional regulatory considerations are applicable. Most important of these are the considerations found in the National Environmental Policy Act (NEPA), wherein deliberate release of any organism containing recombinant DNA into the environment is subject to review and approval by appropriate federal agencies. Environmental release and NEPA compliance are discussed.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Biologicals - Volume 33, Issue 4, December 2005, Pages 253-256
Journal: Biologicals - Volume 33, Issue 4, December 2005, Pages 253-256
نویسندگان
Patricia L. Foley, Richard E. Jr.,