Buch, Englisch, 490 Seiten, HC runder Rücken kaschiert, Format (B × H): 160 mm x 241 mm, Gewicht: 916 g
Buch, Englisch, 490 Seiten, HC runder Rücken kaschiert, Format (B × H): 160 mm x 241 mm, Gewicht: 916 g
ISBN: 978-3-030-35240-0
Verlag: Springer International Publishing
Add to this that devices now frequently serve as delivery systems for drugs, and that drugs may be combined with devices to improve device performance, and the problems of ensuring patient safety with devices has become significantly more complex.
A part of this, requirements for ensuring safety (once based on use of previously acceptable materials – largely polymers and metals) have come to requiring determining which chemical entities are potentially released from a device into patients (and how much is released). Then an appropriate and relevant (yet also conservative) risk assessment must be performed for each identified chemical structure. The challenges inherent in meeting the current requirements are multifold, and this text seeks to identify, understand, and solve all of them.
• 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.
Appendices will contain summarized available biocompatibility data for commonly used device materials (polymers and metals) and safety assessments on the frequently seen moieties in extractions from devices.
Zielgruppe
Research
Autoren/Hrsg.
Fachgebiete
Weitere Infos & Material
1. Introduction – History and Where We are Headed 2. Regulatory Guidance3. Sample Preparation and Biocompatibility Testing4. Testing for Leachables and Extractables5. Where the Data is – And What is It?6. Bridging Issues of Route7. Risk Assessments for Medical Devices8. (Q)SAR 9. Histopathology in Medical Device Studies10. Assessment of Nanomaterial Devices11. Integrated Safety Assessments for Devices12. Toxicity of Common Extractables and Leachables