Risk mitigation strategies for viral contamination of biotechnology products: consideration of best practices [0.03%]
生物技术产品病毒污染的风险缓解策略：最佳实践考量
Amy S Rosenberg,Barry Cherney,Kurt Brorson et al.
Amy S Rosenberg et al.
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...
Shasta McClenahan,Christine Uhlenhaut,Philip R Krause
Shasta McClenahan
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...
Anthony S Lubiniecki
Anthony S Lubiniecki
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...
Introduction to workshop: adventitious viruses in biologics--detection and mitigation strategies [0.03%]
生物制品中美地恩病毒的检测和消减策略研讨会介绍
Arifa S Khan,Patricia Hughes,Michael Wiebe
Arifa S Khan
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...
Lynn Torbeck,Diane Raccasi,Dennis E Guilfoyle et al.
Lynn Torbeck et al.
This is the third in a series of seven articles discussing the Recall Root Cause Research project conducted by the Division of Manufacturing and Product Quality, Center for Drug Evaluation and Research. This paper reviews the regulatory and...
Pulmonary drug delivery: novel pharmaceutical technologies breathe new life into the lungs [0.03%]
肺部药物输送：新型药学技术为呼吸系统带来新希望
Basavaraj K Nanjwade,Sagar A Adichwal,Kishori R Gaikwad et al.
Basavaraj K Nanjwade et al.
Pulmonary drug delivery is a developing technology in which medication is inhaled through the lungs and enters the bloodstream through the alveolar epithelium. Pulmonary drug delivery provides a noninvasive, alternative method to subcutaneo...
Proposal on How To Conduct a Biopharmaceutical Process Failure Mode and Effect Analysis (FMEA) as a Risk Assessment Tool [0.03%]
一种开展生物制药工艺失效模式和影响分析(FMEA)的风险评估工具的方法学建议
Hartmut F Zimmermann,Norbert Hentschel
Hartmut F Zimmermann
With the publication of the quality guideline ICH Q9 "Quality Risk Management" by the International Conference on Harmonization, risk management has already become a standard requirement during the life cycle of a pharmaceutical product. Fa...
Vacuum decay container closure integrity leak test method development and validation for a lyophilized product-package system [0.03%]
冻干产品包装系统的真空衰减容器密封完整性检漏方法的开发与验证
Jayshree Patel,Brian Mulhall,Heinz Wolf et al.
Jayshree Patel et al.
A leak test performed according to ASTM F2338-09 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method was developed and validated for container-closure integrity verification of a lyophilized product...
U Meissner,Harald Stahl,D Steinkellner
U Meissner
As a small leakage from the silicone oil tubes in pharmaceutical freeze dryers may go undetected for several cycles, it provides a major threat to both product safety and the economic performance of such installations. A properly mounted ma...
Variability in syringe components and its impact on functionality of delivery systems [0.03%]
注射器组件的变异性及其对输送系统功能的影响
Nitin Rathore,Pratik Pranay,Bruce Eu et al.
Nitin Rathore et al.
Prefilled syringes and autoinjectors are becoming increasingly common for parenteral drug administration primarily due to the convenience they offer to the patients. Successful commercialization of such delivery systems requires thorough ch...