04367nam 22004815 450 991037782790332120250609111439.03-030-35241-210.1007/978-3-030-35241-7(CKB)4100000010473888(DE-He213)978-3-030-35241-7(MiAaPQ)EBC6121710(PPN)242981593(MiAaPQ)EBC6122085(EXLCZ)99410000001047388820200224d2019 u| 0engurnn|008mamaatxtrdacontentcrdamediacrrdacarrierIntegrated Safety and Risk Assessment for Medical Devices and Combination Products /by Shayne C. Gad1st ed. 2019.Cham :Springer International Publishing :Imprint: Springer,2019.1 online resource (XIII, 490 p. 26 illus., 6 illus. in color.) 3-030-35240-4 Includes bibliographical references and index.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.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 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. .PharmacologyPharmacology/Toxicologyhttps://scigraph.springernature.com/ontologies/product-market-codes/B21007Pharmacology.Pharmacology/Toxicology.681.761681.7610289Gad Shayne Cauthttp://id.loc.gov/vocabulary/relators/aut96171MiAaPQMiAaPQMiAaPQBOOK9910377827903321Integrated Safety and Risk Assessment for Medical Devices and Combination Products1945708UNINA01768nam0 22003373i 450 UBO183217320251003044421.0082476686520140227d1979 ||||0itac50 baengusz01i xxxe z01nElementary statistical quality controlIrving W. BurrNew York and BaselMarcel Dekkerc1979XII, 413 p.24 cm.Statistics: textbooks and monographs25001MIL00351652001 Statistics: textbooks and monographs25Controllo di qualitàMetodi statisticiFIRCFIC083889E658.562CONTROLLO DEI PRODOTTI. CONTROLLO DI QUALITA22658.562015195CONTROLLO DEI PRODOTTI. CONTROLLO DI QUALITA. Metodi statistici21Burr, Irving W.PUVV18357507056712ITIT-00000020140227IT-BN0095 NAP 01LT $NAP 01POZZO LIB.Vi sono collocati fondi di economia, periodici di ingegneria e scienze, periodici di economia e statistica e altri fondi comprendenti documenti di economia pervenuti in dono. UBO1832173Biblioteca Centralizzata di Ateneo1 v. 01LT (AR) 14 B 754 01AR 0700147545 VMA 1 v.B 20140227201402271 v. in due copie 01LT (AR) 14 B 753 01AR 0700147535 VMA (bis 1 v. (2. copia)Y 19950115202010151 v. 01POZZO LIB.ECON MON 3446 0101 0000127155E VMA 1 v.B 2021031820210318 01Elementary statistical quality control68035UNISANNIO