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CBER's Experience With Adaptive Design Clinical Trials.生物制品评估与研究中心在适应性设计临床试验方面的经验。
Ther Innov Regul Sci. 2016 Mar;50(2):195-203. doi: 10.1177/2168479015604181.
2
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IEEE/ACM Trans Comput Biol Bioinform. 2017 Mar-Apr;14(2):498-500. doi: 10.1109/TCBB.2016.2542802. Epub 2016 Mar 23.
3
Post hoc assessment of the immunogenicity of bioengineered factor VIIa demonstrates the use of preclinical tools.生物工程因子 VIIa 的免疫原性的事后评估表明了临床前工具的使用。
Sci Transl Med. 2017 Jan 11;9(372). doi: 10.1126/scitranslmed.aag1286.
4
Distinct Patterns of Expression of Transcription Factors in Response to Interferonβ and Interferonλ1.转录因子对干扰素β和干扰素λ1反应的不同表达模式。
J Interferon Cytokine Res. 2016 Oct;36(10):589-598. doi: 10.1089/jir.2016.0031. Epub 2016 Jul 22.
5
An overview of the regulation of influenza vaccines in the United States.美国流感疫苗监管概述。
Influenza Other Respir Viruses. 2016 Sep;10(5):354-60. doi: 10.1111/irv.12383. Epub 2016 Mar 24.
6
A new algorithmic approach for the extraction of temporal associations from clinical narratives with an application to medical product safety surveillance reports.一种从临床叙述中提取时间关联的新算法方法及其在医疗产品安全监测报告中的应用。
J Biomed Inform. 2016 Aug;62:78-89. doi: 10.1016/j.jbi.2016.06.006. Epub 2016 Jun 17.
7
Substitution of blood coagulation factor X-binding to Ad5 by position-specific PEGylation: Preventing vector clearance and preserving infectivity.通过位置特异性聚乙二醇化替代 Ad5 与凝血因子 X 的结合：防止载体清除并保持感染性。
J Control Release. 2016 Aug 10;235:379-392. doi: 10.1016/j.jconrel.2016.06.022. Epub 2016 Jun 11.
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Identification of Predictive Gene Markers for Multipotent Stromal Cell Proliferation.多能间充质细胞增殖的预测基因标志物鉴定
Stem Cells Dev. 2016 Jun 1;25(11):861-73. doi: 10.1089/scd.2015.0374. Epub 2016 May 2.
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High-performance integrated virtual environment (HIVE): a robust infrastructure for next-generation sequence data analysis.高性能集成虚拟环境（HIVE）：用于下一代序列数据分析的强大基础设施。
Database (Oxford). 2016 Mar 17;2016. doi: 10.1093/database/baw022. Print 2016.
10
Complete Genome Sequences of Dengue Virus Type 1 to 4 Strains Used for the Development of CBER/FDA RNA Reference Reagents and WHO International Standard Candidates for Nucleic Acid Testing.用于开发CBER/FDA RNA参考试剂和WHO核酸检测国际标准候选品的1至4型登革病毒株的全基因组序列
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利用监管科学促进公共卫生，以加强医疗产品的开发与监管：生物制品评估与研究中心的食品药品监督管理局研究

Advancing Public Health Using Regulatory Science to Enhance Development and Regulation of Medical Products: Food and Drug Administration Research at the Center for Biologics Evaluation and Research.

作者信息

Kusinitz Marc, Braunstein Emily, Wilson Carolyn A

机构信息

CBER, FDA, Silver Spring, MD, United States.

出版信息

Front Med (Lausanne). 2017 Jun 12;4:71. doi: 10.3389/fmed.2017.00071. eCollection 2017.

DOI:10.3389/fmed.2017.00071
PMID:28660187
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5466996/
Abstract

Center for Biologics Evaluation and Research enhances and supports regulatory decision-making and policy development. This work contributes to our regulatory mission, advances medical product development, and supports Food and Drug Administration's regulatory response to public health crises. This review presents some examples of our diverse scientific work undertaken in recent years to support our regulatory and public health mission.

摘要

生物制品评估和研究中心加强并支持监管决策和政策制定。这项工作有助于我们的监管使命，推动医疗产品开发，并支持美国食品药品监督管理局对公共卫生危机的监管应对。本综述展示了我们近年来为支持监管和公共卫生使命而开展的各种科学工作的一些实例。