Mahmood Farshid
Mahmood Farshid
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, M...
Application of Risk Assessments in the Design of the Overall Viral Control Strategy Used during the Manufacture and Testing of Live Virus Vaccines [0.03%]
风险评估在活病毒疫苗生产和检定过程中整体病毒控制策略设计中的应用研究
Sridhar Pennathur
Sridhar Pennathur
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, M...
Practicing safe cell culture: applied process designs for minimizing virus contamination risk [0.03%]
安全细胞培养：降低病毒污染风险的工艺设计及应用
Robert D Kiss
Robert D Kiss
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, M...
Robert Sausville,Chantal Cazeault
Robert Sausville
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, M...
FDA post-approval expectations for adventitious virus contamination prevention [0.03%]
美国食品和药物管理局关于预防外源病毒污染的上市后预期要求
Richard L Friedman
Richard L Friedman
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, M...
Adventitious Agents: Issues and Considerations during Pre-Approval Reviews and Inspections [0.03%]
一次性用品：申请批准审评和审查期间遇到的问题及考虑因素
John Eltermann
John Eltermann
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, M...
PDA Cell Substrate Task Force: Emerging Technologies for Virus Detection Technical Document--A Progress Report [0.03%]
关于病毒检测新兴技术的专题小组(PDA细胞基质专题小组)工作报告文书
Kathryn King,Michael Wiebe
Kathryn King
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, M...
Nanostring's nCounter--A True Digital Target Profiling Technology [0.03%]
Nanostring的nCounter——真正意义上的数字化分子检测技术
Michael Morrow,John Donaldson
Michael Morrow
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, M...
David Munroe
David Munroe
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, M...
Advanced Techniques for Detection and Identification of Viral Contaminants Using the Ibis PLEX-ID Universal Biosensor [0.03%]
基于Ibis PLEX-ID通用生物传感器的病毒污染物检测与鉴定新技术
Rangarajan Sampath
Rangarajan Sampath
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, M...