کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
10162772 | 1114359 | 2012 | 10 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
The Potential Clinical Relevance of Visible Particles in Parenteral Drugs
دانلود مقاله + سفارش ترجمه
دانلود مقاله ISI انگلیسی
رایگان برای ایرانیان
کلمات کلیدی
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
پیش نمایش صفحه اول مقاله
![عکس صفحه اول مقاله: The Potential Clinical Relevance of Visible Particles in Parenteral Drugs The Potential Clinical Relevance of Visible Particles in Parenteral Drugs](/preview/png/10162772.png)
چکیده انگلیسی
Visible particulates (VP) are one subclass of defects seen during the final visual inspection of parenteral products and are currently one of the top ten reasons for recalls 1,2. The risk posed by particles is still unclear with limited experience reported in humans but remains an important consideration during the manufacture and use of parenteral products. From the experimental and clinical knowledge of the distribution of particulate matter in the body, clinical complications would include events occurring around parenteral administration e.g., as a result of mechanical pulmonary artery obstruction and injection site reaction, or sub-acute or chronic events e.g., granuloma. The challenge is to better understand the implication for patients of single vials with VP and align the risk with the probabilistic detection process used by manufacturers for accept/reject decisions of individual units of product. © 2012 Wiley Periodicals, Inc. and the American Pharmacists Association
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 101, Issue 8, August 2012, Pages 2635-2644
Journal: Journal of Pharmaceutical Sciences - Volume 101, Issue 8, August 2012, Pages 2635-2644
نویسندگان
Lucette Doessegger, Hanns-Christian Mahler, Piotr Szczesny, Helmut Rockstroh, Georg Kallmeyer, Anja Langenkamp, Joerg Herrmann, Joseph Famulare,