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Integrated Safety and Risk Assessment for Medical Devices and Combination Products

Shayne C. Gad

978-3-030-35241-7

2019
Edition 1
- Identify and verify the most appropriate available data
- As in most cases such data is for a different route of exposure, transform it for use in assessing exposure by the route of interest
- As the duration (and rate) of exposure to moieties released from a device are most frequently different (longer) than what available data speaks to, transformation across tissue is required
- As innate and adaptive immune responses are a central part of device/patient interaction, assessing potential risks on this basis are required
- Incorporating assessments for special populations such as neonates
- Use of (Q)SAR (Quantitative Structure Activity Relationships) modeling in assessments
- Performance and presentation of integrative assessments covering all potential biologic risks
€320 €288
10% OFF

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