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008			200224s2019 gw | o |||| 0|eng d
020			_a9783030352417
024	7		_a10.1007/978-3-030-35241-7 _2doi
040			_aES-MaUEC _bspa _cES-MaUEC _dES-MaUEC
041	0		_aeng
050		4	_aR856.6 _b2019 EB
100	1		_aGad, Shayne C., _eautor _9673163 _d1948-
245	1	0	_aIntegrated Safety and Risk Assessment for Medical Devices and Combination Products _cby Shayne C. Gad
250			_aFirst edition 2019
264		1	_aCham, Switzerland _bSpringer International Publishing _c2019
300			_a1 recurso en línea (XIII, 490 páginas) _b26 ilustraciones, 6 ilustraciones a color
336			_2rdacontent _aTexto _btxt
337			_2rdamedia _aelectrónico _bc
338			_2rdacarrier _arecurso electrónico _bcr
347			_aArchivo de texto _bPDF
490	0		_aBiomedical and Life Sciences (Springer-11642)
505	0		_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.
520	3		_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. .
988			_aSpringer_BiomedLife_31032020
650		7	_2embne _9673164 _aMedicina _xMaterial y equipo _vNormas
650		7	_2embne _9673165 _aMedicina _xMaterial y equipo _xEsterilización
710	2		_aSpringerLink (Online service)
776	0	8	_iPrinted edition: _z9783030352400
776	0	8	_iPrinted edition: _z9783030352424
776	0	8	_iPrinted edition: _z9783030352431
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=http://dx.doi.org/10.1007/978-3-030-35241-7
942			_2lcc _cLE _n0
998			_b04/2020 _dz _eb _zSI