title: Antiviral Information Management System (AIMS): a prototype for operational innovation in drug development.
abstract: This article presents a prototype for an operational innovation in knowledge management (KM). These operational innovations are geared toward managing knowledge efficiently and accessing all available information by embracing advances in bioinformatics and allied fields. The specific components of the proposed KM system are (1) a database to archive hepatitis C virus (HCV) treatment data in a structured format and retrieve information in a query-capable manner and (2) an automated analysis tool to inform trial design elements for HCV drug development. The proposed framework is intended to benefit drug development by increasing efficiency of dose selection and improving the consistency of advice from US Food and Drug Administration (FDA). It is also hoped that the framework will encourage collaboration among FDA, industry, and academic scientists to guide the HCV drug development process using model-based quantitative analysis techniques.
authors.affiliation: Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. Pravin.Jadhav@fda.hhs.gov
authors.forename: Pravin R
authors.initials: PR
authors.lastname: Jadhav
authors.forename: Lauren
authors.initials: L
authors.lastname: Neal
authors.forename: Jeff
authors.initials: J
authors.lastname: Florian
authors.forename: Ying
authors.initials: Y
authors.lastname: Chen
authors.forename: Lisa
authors.initials: L
authors.lastname: Naeger
authors.forename: Sarah
authors.initials: S
authors.lastname: Robertson
authors.forename: Guoxing
authors.initials: G
authors.lastname: Soon
authors.forename: Debra
authors.initials: D
authors.lastname: Birnkrant
mesh_terms: D000998:Antiviral Agents / Q000008:administration & dosage*; D019295:Computational Biology / Q000379:methods*; D003299:Cooperative Behavior; D004305:Dose-Response Relationship, Drug; D015195:Drug Design; D004345:Drug Industry / Q000379:methods*; D006526:Hepatitis C / Q000188:drug therapy; D006801:Humans; D008954:Models, Biological; D012107:Research Design; D014481:United States; D014486:United States Food and Drug Administration; D000078329:Workforce
chemical_list: D000998:Antiviral Agents