In-use physicochemical and microbiological stability of biological parenteral products

被引：21
|
作者：
Ricci, Margaret Speed [1 ]
Frazier, Michelle [2 ]
Moore, Jamie [3 ]
Cromwell, Mary [4 ]
Galush, William J. [4 ]
Patel, Ankit R. [5 ]
Adler, Michael
Altenburger, Ulrike
Grauschopf, Ulla
Goldbach, Pierre
Fast, Jonas L. [6 ]
Kraemer, Irene [7 ,8 ]
Mahler, Hanns-Christian [6 ]
机构：
[1] Genentech Inc, Drug Prod Dev, Proc Dev, San Francisco, CA 94080 USA
[2] Amgen Inc, Regulatory Affairs, Thousand Oaks, CA USA
[3] Genentech Inc, Early Stage Pharmaceut Dev, San Francisco, CA 94080 USA
[4] Genentech Inc, Late Stage Pharmaceut Dev, San Francisco, CA 94080 USA
[5] Genentech Inc, Early Stage Pharmaceut Dev, Pharmaceut Dev, Pharma Tech Dev Biol US, San Francisco, CA 94080 USA
[6] F Hoffmann LaRoche Ltd, Pharmaceut Dev & Supplies, Pharma Tech Dev Biol EU, Basel, Switzerland
[7] Johannes Gutenberg Univ Hosp, Dept Pharm, Med Ctr, Mainz, Germany
[8] Johannes Gutenberg Univ Hosp, Sch Pharm, Clin Pharm, Mainz, Germany
来源：
AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY | 2015年 / 72卷 / 05期
关键词：
MONOCLONAL-ANTIBODY; ANTICANCER DRUGS; INFUSION BOTTLES; INSULIN; CONTAMINATION; DELIVERY; BAGS; COMPATIBILITY; ALEMTUZUMAB; ADSORPTION;
D O I：
10.2146/ajhp140098
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
引用
收藏
页码：396 / 407
页数：12
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