کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
5033003 1370004 2017 7 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Quality-by-design of nanopharmaceuticals - a state of the art
ترجمه فارسی عنوان
کیفیت طراحی توسط نانوفارمینت ها - حالت پیشرفته
کلمات کلیدی
موضوعات مرتبط
مهندسی و علوم پایه سایر رشته های مهندسی مهندسی پزشکی
چکیده انگلیسی
Pharmaceutical Quality-by-Design is a risk-based approach of drug development relying on the understanding of both the product and the process. This state of the art analyzes 24 studies published during the last ten years. A risk modeling of the nanomaterial formulation and manufacturing is firstly presented. After a brief history of the QbD approach, its basic components are recalled in a second part. The most critical material attributes, process parameters, quality variables and measurement technologies are reviewed. Specific deficiencies are also emphasized such as the absence of prior risk assessment, production scale-up, process analytical technology and control strategy. Finally, perspectives and development priorities are drawn to improve the implementation of this integrative approach of quality and safety in nanomedicine.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Nanomedicine: Nanotechnology, Biology and Medicine - Volume 13, Issue 7, October 2017, Pages 2151-2157
نویسندگان
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