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Drugs and Health Products

Phonetic Orthographic Computer Analysis (POCA) System

Date 2003-10-20

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Presented by

Dr. Rick Shangraw
Project Performance Corporation

Outline

  • Overall System Design

  • The Medical Repository

  • System Demonstration

System Objectives

  • Accessibility
    • Web-based
    • Varying levels of permission for varied tasks
    • Ease of use

  • Efficient Use of Expert Time
    • Decrease paper production
    • Increase analysis time while decreasing search time

  • Scientifically-Based Analysis
    • Reliability of Algorithms (Recall)
    • Predictive Validity of Algorithms (Precision)

System History

  • Pilot System Development Funded by the U.S. Food and Drug Administration (FDA)

  • Development Team
    • Project Performance Corporation
    • Bonnie Dorr, University of Maryland
    • Greg Kondrak, University of Alberta

  • Pilot System will be Tested by FDA

Safety Evaluation Process - Before

Before Computer Analysis:

Safety Evaluation Process - Before

System Architecture

System Architecture

Safety Evaluation Process - Computer Assisted

With Computer Analysis:

Safety Evaluation Process - Computer Assisted

Medical Repository

  • Oracle Database

  • Features
    • Populated with FDA Corporate Database
      • Approved and Unapproved Proprietary Names
      • Additional Factors (drug strengths, dosing intervals, dosage forms and routes of administration)
    • Ability to Import and Manually Update the Repository

  • Next Steps
    • Biologics
    • Supplements and Herbals
    • Medical Terminology

System Demonstration

  • Login / Security

  • Search Capabilities
    • Phonetic
    • Orthographic
    • Other Factors

  • Workflow
    • Saved Searches
    • Watch List

  • System Administration