Integrated Safety and Risk Assessment for Medical Devices and Combination Products

• Κύριος συγγραφέας: Gad, Shayne C. (Συγγραφέας, http://id.loc.gov/vocabulary/relators/aut)
• Συγγραφή απο Οργανισμό/Αρχή: SpringerLink (Online service)
• Μορφή: Ηλεκτρονική πηγή Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Cham : Springer International Publishing : Imprint: Springer, 2019.
• Έκδοση: 1st ed. 2019.
• Θέματα: Pharmacology.; Pharmacology/Toxicology.

While the safety assessment ("biocompatibility") of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed...

Πίνακας περιεχομένων:

• 1. Introduction - History and Where We are Headed
• 2. Regulatory Guidance
• 3. Sample Preparation and Biocompatibility Testing
• 4. Testing for Leachables and Extractables
• 5. Where the Data is - And What is It?
• 6. Bridging Issues of Route
• 7. Risk Assessments for Medical Devices
• 8. (Q)SAR
• 9. Histopathology in Medical Device Studies
• 10. Assessment of Nanomaterial Devices
• 11. Integrated Safety Assessments for Devices
• 12. Toxicity of Common Extractables and Leachables.