title: Knowledge management for efficient quantitative analyses during regulatory reviews.
abstract: 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.
authors: 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.
authors: Kevin
authors: K
authors: Krudys
authors: Fang
authors: F
authors: Li
authors: Jeffry
authors: J
authors: Florian
authors: Christoffer
authors: C
authors: Tornoe
authors: Ying
authors: Y
authors: Chen
authors: Atul
authors: A
authors: Bhattaram
authors: Pravin
authors: P
authors: Jadhav
authors: Lauren
authors: L
authors: Neal
authors: Yaning
authors: Y
authors: Wang
authors: Joga
authors: J
authors: Gobburu
authors: Peter I D
authors: PI
authors: Lee
mesh_terms: D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000592:standards*; D017598:Efficiency, Organizational / Q000331:legislation & jurisprudence / Q000592:standards*; D005069:Evaluation Studies as Topic; D006801:Humans; D058436:Knowledge Management / Q000592:standards*; D010601:Pharmacology, Clinical / Q000331:legislation & jurisprudence / Q000592:standards; D011634:Public Health / Q000331:legislation & jurisprudence / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000592:standards*