| Knowledge management for efficient quantitative analyses during regulatory reviews. | |
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MedLine Citation:
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PMID: 22111855 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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Knowledge management comprises the strategies and methods employed to generate and leverage knowledge within an organization. This report outlines the activities within the Division of Pharmacometrics at the US FDA to effectively manage knowledge with the ultimate goal of improving drug development and advancing public health. The infrastructure required for pharmacometric knowledge management includes provisions for data standards, queryable databases, libraries of modeling tools, archiving of analysis results and reporting templates for effective communication. Two examples of knowledge management systems developed within the Division of Pharmacometrics are used to illustrate these principles. The benefits of sound knowledge management include increased productivity, allowing reviewers to focus on research questions spanning new drug applications, such as improved trial design and biomarker development. The future of knowledge management depends on the collaboration between the FDA and industry to implement data and model standards to enhance sharing and dissemination of knowledge. |
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Authors:
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Kevin Krudys; Fang Li; Jeffry Florian; Christoffer Tornoe; Ying Chen; Atul Bhattaram; Pravin Jadhav; Lauren Neal; Yaning Wang; Joga Gobburu; Peter Id Lee |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Expert review of clinical pharmacology Volume: 4 ISSN: 1751-2441 ISO Abbreviation: Expert Rev Clin Pharmacol Publication Date: 2011 Nov |
Date Detail:
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Created Date: 2011-11-24 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101278296 Medline TA: Expert Rev Clin Pharmacol Country: England |
Other Details:
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Languages: eng Pagination: 697-703 Citation Subset: IM |
Affiliation:
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Division of Pharmacometrics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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