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Browse Items (103 total)
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- Creator:
- Colleen S. Kraft, Mark G. Kortepeter, Bruce Gordon, Lauren M. Sauer, Erica S. Shenoy, Daniel P. Eiras, LuAnn Larson, Jennifer A. Garland, Aneesh K. Mehta, Kevin Barrett, Connie S. Price, Caroline Croyle, Lauren R. West, Brooke Noren, Susan Kline,…
- Subject:
- Research
- Item Type:
- Publication
- Date Last Updated:
- 2019-02-19
- Description:
- The 2013-2016 epidemic of Ebola virus disease (EVD) that originated in West Africa underscored many of the challenges to conducting clinical research during an ongoing infectious disease epidemic, both in the most affected countries of Guinea,…
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- Creator:
- Davis CW, Jackson KJL, McElroy AK, Halfmann P, Huang J, Chennareddy C, Piper AE, Leung Y, Albariño CG, Crozier I, Ellebedy AH, Sidney J, Sette A, Yu T, Nielsen SCA, Goff AJ, Spiropoulou CF, Saphire EO, Cavet G, Kawaoka Y, Mehta AK, Glass PJ, Boyd SD,…
- Subject:
- Research
- Item Type:
- Publication
- Date Last Updated:
- 2019-05-30
- Description:
- Ebola virus (EBOV) remains a public health threat. We performed a longitudinal study of B cell responses to EBOV in four survivors of the 2014 West African outbreak.
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- Creator:
- Dean, Christina L., Jay W. Hooper, John M. Dye, Samantha E. Zak, Scott A. Koepsell, Laurence Corash, Richard J. Benjamin, Steve Kwilas, Shannon Bonds, Anne M. Winkler, and Colleen S. Kraft.
- Subject:
- Research
- Item Type:
- Publication
- Date Last Updated:
- 2020-03-04
- Description:
- In 2014, passive immunization by transfusion of Ebola convalescent plasma (ECP) was considered for treating patients with acute Ebola virus disease (EVD).
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- Creator:
- Editor Bruce Hawkins
- Subject:
- Research
- Item Type:
- Publication
- Date Last Updated:
- 2019
- Description:
- The purpose of these guidelines is to describe a standardized approach for the management of investigational drug products by the clinical research pharmacy, pharmaceutical industry, and cooperative and research network groups.
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- Creator:
- Ellebedy, A. H., K. J. Jackson, H. T. Kissick, H. I. Nakaya, C. W. Davis, K. M. Roskin, A. K. McElroy, C. M. Oshansky, R. Elbein, S. Thomas, G. M. Lyon, C. F. Spiropoulou, A. K. Mehta, P. G. Thomas, S. D. Boyd, and R. Ahmed
- Subject:
- Research
- Item Type:
- Publication
- Date Last Updated:
- 2016-10
- Description:
- Antigen-specific B cells bifurcate into antibody-secreting cells (ASCs) and memory B cells (MBCs) after infection or vaccination.
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- Creator:
- Errett, Nicole A., Lauren M. Sauer, and Lainie Rutkow.
- Subject:
- Research
- Item Type:
- Publication
- Date Last Updated:
- 2020-02
- Description:
- In our increasingly interconnected world, the potential for emerging infectious diseases (EIDs) to spread globally is of paramount concern.
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- Creator:
- Fallah MP, Skrip LA.
- Subject:
- Research
- Item Type:
- Publication
- Date Last Updated:
- 2019-01-24
- Description:
- This article reviews the testing of Ebola therapies during the outbreak.
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- Creator:
- FDA
- Subject:
- Research
- Item Type:
- Hyperlink
- Date Last Updated:
- 2021-05
- Description:
- Guidance for Sponsors, Clinical Investigators, and IRBs. Information for investigational new drugs (IND).
Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA…
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- Creator:
- FDA
- Subject:
- Research
- Item Type:
- Hyperlink
- Date Last Updated:
- 2022-07-20
- Description:
- Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators…
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- Creator:
- FDA
- Subject:
- Research
- Item Type:
- Hyperlink
- Date Last Updated:
- 2023-05-12
- Description:
- The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases, by facilitating the…
