کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
10162115 1114317 2015 6 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Technical Decision-Making with Higher Order Structure Data: Starting a New Dialogue
ترجمه فارسی عنوان
تصمیم گیری فنی با داده های ساختار سفارش بالاتر: شروع گفتگوی جدید
موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی اکتشاف دارویی
چکیده انگلیسی
Characterization of the higher order structure (HOS) of biological products has been growing in importance in recent years. Scientists in the biopharmaceutical industry, academic researchers, and regulators are all increasingly aware of the critical role that HOS plays in maintaining the stability and intended biological function of biopharmaceutical products. We organized a consortium of scientists and researchers from industry and academic institutions to address how HOS data can be used most effectively to drive decisions during product development. In this commentary, we introduce the purpose, objectives, and scope of the consortium and then provide some brief points to consider in the context of characterizing HOS of biopharmaceutical products. Scientific advances in HOS analysis, as well as continued dialogue among academia, industry, and regulatory agencies will ensure that appropriate methodologies are used to inform technical decision-making during biopharmaceutical development.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 104, Issue 4, April 2015, Pages 1240-1245
نویسندگان
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