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Risk Management: Safety Specification Identification and - - PowerPoint PPT Presentation
Risk Management: Safety Specification Identification and - - PowerPoint PPT Presentation
Risk Management: Safety Specification Identification and Methodologies
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Identify: What is known! What is not known? Safety concerns Drug Disease Target population
- Pharmacodynamics
- Pharmacokinetics
- How will it be used?
- Adverse event profile
- Class effects?
- Interactions?
- Level of confidence?
- Who was studied?
- Who wasn’t studied?
- Risk factors?
- What events can we
expect in this population?
- Natural history
- Epidemiology
- What events occur
as part of disease? Important identified risks Important potential risks Important missing information Safety specification
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