کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2484864 | 1114339 | 2012 | 5 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Workshop on predictive science of the immunogenicity aspects of particles in biopharmaceutical products
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کلمات کلیدی
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
پیش نمایش صفحه اول مقاله
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چکیده انگلیسی
Particles in protein therapeutics and concerns for a potential correlation with product immunogenicity are increasingly becoming the focus of recent publications and scientific forums. The consensus of academic, industrial, and regulatory scientists is that this area is not well understood and will require in-depth research because of the potential impact on the product safety and efficacy. This commentary presents a summary of the 1-day workshop entitled “Predictive Science of the Immunogenicity Aspects of Particles in Biopharmaceutical Products,” which discussed the current state of analytical resources for quantitation and characterization of protein aggregates and potential paths for developing predictive preclinical tools. © 2012 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 101:3555-3559, 2012
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 101, Issue 10, October 2012, Pages 3555-3559
Journal: Journal of Pharmaceutical Sciences - Volume 101, Issue 10, October 2012, Pages 3555-3559
نویسندگان
Ewa Marszal, Elizabeth Fowler,