Summary of DIA Workshop: Comparability Challenges: Regulatory and Scientific Issues in the Assessment of Biopharmaceuticals

被引：7
|
作者：
Lewis, Richard M. [1 ]
Cosenza, Mary Ellen [1 ]
机构：
[1] Amgen Inc, Regulatory Affairs, Thousand Oaks, CA USA
来源：
DRUG INFORMATION JOURNAL | 2010年 / 44卷 / 04期
关键词：
Comparability; Regulatory; Biological product; Pharmacokinetics; Pharmacodynamics; Biochemical; Analyses; MONOCLONAL-ANTIBODY; GLYCOSYLATION; PHARMACOKINETICS; PANITUMUMAB; RECEPTOR;
D O I：
10.1177/009286151004400413
中图分类号：
R19 [保健组织与事业（卫生事业管理）];
学科分类号：
摘要：
On February 3-4, 2009, a DIA Workshop was held to review and discuss comparability challenges and issues for biotechnology-derived pharmaceuticals. The workshop was held in the Washington, DC, area and was attended by representatives from the FDA and biotech and pharmaceutical industries. The expectation was to develop a consensus on which data are necessary to provide assurance of comparability for manufacturing changes made to biotechnology products during different stages of development or postmarketing. Numerous case studies were reviewed and discussed to build on best practices and recognize successful approaches to comparability.
引用
收藏
页码：485 / 504
页数：20
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