کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
5856379 | 1131973 | 2015 | 11 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Nonclinical safety testing of biopharmaceuticals - Addressing current challenges of these novel and emerging therapies
ترجمه فارسی عنوان
تست ایمنی غیر کلاسیک از داروهای بیولوژیک - در حال حاضر با توجه به چالش های این درمان های جدید و در حال ظهور
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کلمات کلیدی
موضوعات مرتبط
علوم زیستی و بیوفناوری
علوم محیط زیست
بهداشت، سم شناسی و جهش زایی
چکیده انگلیسی
Non-clinical safety testing of biopharmaceuticals can present significant challenges to human risk assessment with these often innovative and complex drugs. Hot Topics in this field were discussed recently at the 4th Annual European Biosafe General Membership meeting. In this feature article, the presentations and subsequent discussions from the main sessions are summarized. The topics covered include: (i) wanted versus unwanted immune activation, (ii) bi-specific protein scaffolds, (iii) use of Pharmacokinetic (PK)/Pharmacodynamic (PD) data to impact/optimize toxicology study design, (iv) cytokine release and challenges to human translation (v) safety testing of cell and gene therapies including chimeric antigen receptor T (CAR-T) cells and retroviral vectors and (vi) biopharmaceutical development strategies encompassing a range of diverse topics including optimizing entry of monoclonal antibodies (mAbs) into the brain, safety testing of therapeutic vaccines, non-clinical testing of biosimilars, infection in toxicology studies with immunomodulators and challenges to human risk assessment, maternal and infant anti-drug antibody (ADA) development and impact in non-human primate (NHP) developmental toxicity studies, and a summary of an NC3Rs workshop on the future vision for non-clinical safety assessment of biopharmaceuticals.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Regulatory Toxicology and Pharmacology - Volume 73, Issue 1, October 2015, Pages 265-275
Journal: Regulatory Toxicology and Pharmacology - Volume 73, Issue 1, October 2015, Pages 265-275
نویسندگان
Frank R. Brennan, Andreas Baumann, Guenter Blaich, Lolke de Haan, Rajni Fagg, Andrea Kiessling, Sven Kronenberg, Mathias Locher, Mark Milton, Jay Tibbitts, Peter Ulrich, Lucinda Weir,