research:angioedema
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research:angioedema [2016/12/13 17:27] jduke |
research:angioedema [2017/12/14 05:54] (current) schuemie |
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| **Rationale:** The Food and Drug Administration (FDA) has [[http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm491645.htm|recently announced]] that they are evaluating the need for regulatory action regarding a potential association between exposure to the anti-seizure drug Keppra and angioedema. OHDSI seeks to support evidence generation for questions of importance to FDA and other stakeholders seeking to protect and promote the public's health. | **Rationale:** The Food and Drug Administration (FDA) has [[http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm491645.htm|recently announced]] that they are evaluating the need for regulatory action regarding a potential association between exposure to the anti-seizure drug Keppra and angioedema. OHDSI seeks to support evidence generation for questions of importance to FDA and other stakeholders seeking to protect and promote the public's health. | ||
| - | **Project Lead(s):** Jon Duke, Patrick Ryan, Marc Suchard, George Hripcsak, [?Adler], Christian Reich, Yuriy Khoma, Marie-Sophie Schwalm, Yonghui Hu, Martijn Schuemie. | + | **Project Lead(s):** Jon Duke, Patrick Ryan, Marc Suchard, George Hripcsak, [?Adler], Christian Reich, Yuriy Khoma, Marie-Sophie Schwalm, Yonghui Hu, [Stanford- Juan?], Martijn Schuemie. |
| **Coordinating Institution(s):** Regenstrief Institute / Georgia Tech | **Coordinating Institution(s):** Regenstrief Institute / Georgia Tech | ||
| - | ** Additional Participants (currently seeking additional collaborators):** | + | **Participating Institution(s):** Regenstrief Institute, Georgia Tech, Janssen Research and Development, Columbia University, University of California Los Angeles, University of Texas Houston, Stanford University, QuintilesIMS. |
| - | + | ||
| - | Any interested collaborators please contact Jon Duke at jonduke@regenstrief.org and I will be happy to add you to the collaborator list. | + | |
| - | **Participating Institution(s):** Regenstrief Institute, Janssen Research and Development, Columbia University, University of California, Los Angeles | + | **Full Protocol:** [[https://github.com/OHDSI/StudyProtocols/blob/master/KeppraAngioedema/extras/KeppraandAngioedemaRiskStudyProtocolv0.5.docx?raw=true|Keppra and Angioedema Risk Protocol]] |
| - | + | ||
| - | **Full Protocol:** [[https://drive.google.com/file/d/0BzotZ5gIRvegT3Y5djBOUldzaVE/view?usp=sharing|Keppra and Angioedema Risk Protocol]] | + | |
| **Initial Proposal Date:** 5/3/2016 | **Initial Proposal Date:** 5/3/2016 | ||
research/angioedema.1481650054.txt.gz · Last modified: 2016/12/13 17:27 by jduke
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