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Integrated Safety and Risk Assessment for Medical Devices and Combination Products

紀錄類型:	書目-語言資料,印刷品 : Monograph/item
正題名/作者:	Integrated Safety and Risk Assessment for Medical Devices and Combination Products/ by Shayne C. Gad.
作者:	Gad, Shayne C.
面頁冊數:	XIII, 490 p. 26 illus., 6 illus. in color.online resource. :
Contained By:	Springer Nature eBook
標題:	Pharmacology. -
電子資源:	https://doi.org/10.1007/978-3-030-35241-7
ISBN:	9783030352417

Integrated Safety and Risk Assessment for Medical Devices and Combination Products
Gad, Shayne C.

Integrated Safety and Risk Assessment for Medical Devices and Combination Products[electronic resource] /by Shayne C. Gad. - 1st ed. 2019. - XIII, 490 p. 26 illus., 6 illus. in color.online resource.

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. .

ISBN: 9783030352417

Standard No.: 10.1007/978-3-030-35241-7doiSubjects--Topical Terms:

583819
Pharmacology.

LC Class. No.: RM1-950

Dewey Class. No.: 615

Integrated Safety and Risk Assessment for Medical Devices and Combination Products
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