کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2579043 | 1130027 | 2012 | 9 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Monoclonal Antibodies for Therapeutic Use: Specific Characteristics of Clinical Development, Evaluation by the Agencies, and Long-term Monitoring of Safety
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کلمات کلیدی
HASPK-PDFDAAnti-tumor necrosis factor-αTMDDNOAELMABELMoAbADCCRMPSMRASMRIgGCDREMAPMLCDCnatural killer - (سلول های) کشنده طبیعیantibody dependent cellular cytotoxicity - آنتی بادی سمیت سلولی سلولی وابسته استEuropean Medicines agency - آژانس دارویی اروپاHER - اوimmunoglobulin G - ایمونوگلوبولین GFood and Drug Administration - سازمان غذا و داروAnti-TNFα - ضد TNFαanti-VEGF - ضد VEGFPharmacokinetic-pharmacodynamic - فارماکوکینتیک-فارماکودینامیکanti-vascular endothelial growth factor - فاکتور رشد اندوتلیال ضد عروقیTarget-mediated drug disposition - قرار دادن هدف دارو هدفمندProgressive multifocal leukoencephalopathy - لکوآنسفالوپاتی چند نفره پیشرفتهcomplementarity determining region - منطقه تعریف مکملNo observed adverse effect level - هیچ عوارض جانبی مشاهده نشدهMonoclonal antibodies - پادتنهای تَکتیره
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
فارماکولوژی، سم شناسی و اقلام دارویی (عمومی)
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
Monoclonal antibodies (MoAb) are very different from other drugs. The Round Table aimed to determine whether the specific characteristics of MoAb have repercussions on their clinical development, evaluation by the health authorities, and long-term monitoring. As regards the structure-activity relationship of MoAb, classification according to mechanism of action (neutralising or agonist MoAb, cytolytic MoAb) is more relevant than to their degree of humanisation. Recommendations on their clinical development would be useful since the early phases give rise to a number of problems and are insufficiently codified. The pharmacokinetic profile is very different from that of other drugs. The concentration-effect relationship is difficult to study since the biomarkers may be apparently disconnected from the therapeutic effect. The methodology for evaluation of MoAb by the agencies, and postmarketing surveillance do not differ from the procedures used for other drugs; however, MoAb bring together a number of specific characteristics as compared with other drugs.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Thérapie - Volume 67, Issue 4, JulyâAugust 2012, Pages 329-337
Journal: Thérapie - Volume 67, Issue 4, JulyâAugust 2012, Pages 329-337
نویسندگان
Gilles Paintaud, Marine Diviné, Philippe Lechat,