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Safety evaluation in the development...
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McCord, Marian G.
Safety evaluation in the development of medical devices and combination products
Record Type:
Electronic resources : Monograph/item
Title/Author:
Safety evaluation in the development of medical devices and combination products/ Shayne C. Gad, Marian G. McCord.
Author:
Gad, Shayne C.,
other author:
Gad, Shayne C.,
Published:
New York :Informa Healthcare, : c2008.,
Description:
viii, 300 p. :ill. :
Notes:
Rev. ed. of: Safety evaluation of medical devices / Shayne Cox Gad. 2nd ed., Rev. and expanded. c2002.
Subject:
Biocompatibility - Testing. -
Online resource:
Distributed by publisher. Purchase or institutional license may be required for access.
ISBN:
9781439809488 (e-book : PDF)
Safety evaluation in the development of medical devices and combination products
Gad, Shayne C.,1948-
Safety evaluation in the development of medical devices and combination products
[electronic resource] /Shayne C. Gad, Marian G. McCord. - 3rd ed. - New York :Informa Healthcare,c2008. - viii, 300 p. :ill.
Rev. ed. of: Safety evaluation of medical devices / Shayne Cox Gad. 2nd ed., Rev. and expanded. c2002.
Includes bibliographical references and index.
Regulatory aspects and strategy in medical device and bio materials safety evaluation -- Road map to test selections -- Materials in medical device design -- What to test : sampling and sample preparation -- Cytotoxicity testing -- Hematocompatibiity -- Local tissue tolerance -- Immunotoxicology -- Implantation biology and studies -- Acute systemic testing device safety evaluation -- Genotoxicity -- Subchronic and chronic toxicity and reproductive and developmental toxicity -- Carcinogenicity -- Degradation products and impurties -- Combination products -- Clinical studies for medical devices -- Special studies -- Toxicokinetics in biomaterial and device safety evaluation -- Case histories and problem resolution.
Mode of access: World Wide Web.
ISBN: 9781439809488 (e-book : PDF)Subjects--Topical Terms:
344746
Biocompatibility
--Testing.Index Terms--Genre/Form:
96803
Electronic books.
Safety evaluation in the development of medical devices and combination products
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Safety evaluation in the development of medical devices and combination products
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[electronic resource] /
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Shayne C. Gad, Marian G. McCord.
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3rd ed.
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New York :
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c2008.
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Informa Healthcare,
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viii, 300 p. :
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ill.
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Rev. ed. of: Safety evaluation of medical devices / Shayne Cox Gad. 2nd ed., Rev. and expanded. c2002.
504
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Includes bibliographical references and index.
505
0
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Regulatory aspects and strategy in medical device and bio materials safety evaluation -- Road map to test selections -- Materials in medical device design -- What to test : sampling and sample preparation -- Cytotoxicity testing -- Hematocompatibiity -- Local tissue tolerance -- Immunotoxicology -- Implantation biology and studies -- Acute systemic testing device safety evaluation -- Genotoxicity -- Subchronic and chronic toxicity and reproductive and developmental toxicity -- Carcinogenicity -- Degradation products and impurties -- Combination products -- Clinical studies for medical devices -- Special studies -- Toxicokinetics in biomaterial and device safety evaluation -- Case histories and problem resolution.
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Also available in print edition.
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Mode of access: World Wide Web.
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Biocompatibility
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Testing.
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344746
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Biomedical materials
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Biomedical materials
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Testing.
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Gad, Shayne C.,
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McCord, Marian G.
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Distributed by publisher. Purchase or institutional license may be required for access.
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