کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2593021 1132064 2006 12 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Non-clinical development of cancer vaccines: Regulatory considerations
موضوعات مرتبط
علوم زیستی و بیوفناوری علوم محیط زیست بهداشت، سم شناسی و جهش زایی
پیش نمایش صفحه اول مقاله
Non-clinical development of cancer vaccines: Regulatory considerations
چکیده انگلیسی

This paper discusses regulatory requirements essential during the non-clinical development of cancer vaccines. DNA vaccines and vaccines containing monoclonal antibodies are specifically addressed. ICH, CHMP, FDA, and WHO guidance documents in addition to scientific literature are reviewed and the regulatory framework, including respective EMEA and the FDA divisions responsible for review and assessment of cancer vaccines, is described. Selection criteria for an appropriate animal model for efficacy and/or toxicity studies are discussed.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Regulatory Toxicology and Pharmacology - Volume 44, Issue 3, April 2006, Pages 226–237
نویسندگان
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