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Antiviral Information Management System (AIMS): A Prototype for Operational Innovation in Drug Development
Author(s) -
Jadhav Pravin R.,
Neal Lauren,
Florian Jeff,
Chen Ying,
Naeger Lisa,
Robertson Sarah,
Soon Guoxing,
Birnkrant Debra
Publication year - 2010
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270010376771
Subject(s) - drug development , drug , medicine , intensive care medicine , process management , knowledge management , business , computer science , pharmacology
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.