کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
8551520 1562108 2018 5 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Nonclinical evaluation of immunological safety in Göttingen Minipigs: The CONFIRM initiative
موضوعات مرتبط
علوم زیستی و بیوفناوری علوم محیط زیست بهداشت، سم شناسی و جهش زایی
پیش نمایش صفحه اول مقاله
Nonclinical evaluation of immunological safety in Göttingen Minipigs: The CONFIRM initiative
چکیده انگلیسی
There is a growing need to consider non-rodent species for the immunological safety evaluation of drug candidates. The EU Framework-6 RETHINK Project demonstrated that the Göttingen Minipig is a relevant animal model for regulatory toxicology studies. Extensive knowledge on the immune system of domestic pigs is available and fewer differences from humans have been identified as compared to other species, such as mice or non-human primates. Minipig data are too scarce to allow for claiming full immunological comparability with domestic pigs. Another gap limiting minipig use for immunological safety evaluation is the lack of a qualified and validated database. However, available data lend support to the use of minipigs. The need for a COllaborative Network For Immunological safety Research in Minipigs (the CONFIRM Initiative) was obvious. It is intended to trigger immunological safety research in Göttingen Minipigs, to assist and synergize fundamental, translational and regulatory investigative efforts relevant to the immunological safety evaluation of pharmaceuticals and biologics, and to spread current knowledge and new findings to the scientific and regulatory toxicology community.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Regulatory Toxicology and Pharmacology - Volume 94, April 2018, Pages 271-275
نویسندگان
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