LEADER 04367nam 22004815 450 001 9910377827903321 005 20250609111439.0 010 $a3-030-35241-2 024 7 $a10.1007/978-3-030-35241-7 035 $a(CKB)4100000010473888 035 $a(DE-He213)978-3-030-35241-7 035 $a(MiAaPQ)EBC6121710 035 $a(PPN)242981593 035 $a(MiAaPQ)EBC6122085 035 $a(EXLCZ)994100000010473888 100 $a20200224d2019 u| 0 101 0 $aeng 135 $aurnn|008mamaa 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aIntegrated Safety and Risk Assessment for Medical Devices and Combination Products /$fby Shayne C. Gad 205 $a1st ed. 2019. 210 1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2019. 215 $a1 online resource (XIII, 490 p. 26 illus., 6 illus. in color.) 311 08$a3-030-35240-4 320 $aIncludes bibliographical references and index. 327 $a1. 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. 330 $aWhile 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 as devices assumed a much more important role in healthcare and became more complex in both composition and in their design and operation. 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. . 606 $aPharmacology 606 $aPharmacology/Toxicology$3https://scigraph.springernature.com/ontologies/product-market-codes/B21007 615 0$aPharmacology. 615 14$aPharmacology/Toxicology. 676 $a681.761 676 $a681.7610289 700 $aGad$b Shayne C$4aut$4http://id.loc.gov/vocabulary/relators/aut$096171 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910377827903321 996 $aIntegrated Safety and Risk Assessment for Medical Devices and Combination Products$91945708 997 $aUNINA