美国食品药品监督管理局（FDA）批准后对预防外来病毒污染的期望。
FDA post-approval expectations for adventitious virus contamination prevention.
作者信息
Friedman Richard L
机构信息
Office of Manufacturing and Product Quality, Office of Compliance, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
出版信息
PDA J Pharm Sci Technol. 2011 Nov-Dec;65(6):698-712. doi: 10.5731/pdajpst.2011.00846.
PMID:22294604
Abstract
CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA).
摘要
会议论文集 《PDA/FDA生物制品中潜在病毒：检测与缓解策略研讨会论文集》，美国马里兰州贝塞斯达；2010年12月1日至3日 客座编辑：阿里法·汗（马里兰州贝塞斯达）、帕特里夏·休斯（马里兰州贝塞斯达）和迈克尔·维贝（加利福尼亚州旧金山）
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