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Updated: May 11, 2026
05:10
Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
Published on: December 11, 2016
Defining the pharmaceutical system to support proactive drug safety
Vicki R Lewis1, Angelica Hernandez, Margaret Meadors
1MedStar National Center for Human Factors in Healthcare, Washington, DC 20008, USA. Vicki.R.Lewis@medicalhfe.org
Current Drug Safety
|May 10, 2013
Summary
This study models the U.S. pharmaceutical system to improve drug safety. Applying a systems approach can proactively identify risks and enhance pharmaceutical safety across the industry.
Area of Science:
- Pharmaceutical science
- Systems engineering
- Risk management
Background:
- High-risk industries like aviation and nuclear power have improved safety using systems approaches.
- The pharmaceutical industry currently lacks a comprehensive systems model for safety and risk mitigation.
Purpose of the Study:
- To develop a preliminary systems model of the U.S. pharmaceutical industry.
- To define the goals, roles, and processes of pharmaceutical subsystems.
- To provide a framework for assessing and addressing pharmaceutical safety issues.
Main Methods:
- Literature review of academic publications, regulatory guidelines, and industry trade documents.
- Analysis of existing policies and established best practices.
- Development of a conceptual model based on synthesized information.
Main Results:
- A preliminary model of the U.S. pharmaceutical system has been created.
- Key subsystems, their roles, and processes have been identified.
- The model highlights areas for potential safety improvements.
Conclusions:
- A systems approach is crucial for advancing pharmaceutical safety.
- The developed model offers a foundation for proactive risk analysis.
- Implementing this model can lead to significant improvements in drug safety and risk mitigation.
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