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Safety evaluation in the development...

McCord, Marian G.

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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:	McCord, Marian G.
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.
[NT 15003449]:	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.
Subject:	Biomedical materials - Testing. -
Online resource:	http://marc.crcnetbase.com/isbn/9781439809488Distributed by publisher. Purchase or institutional license may be required for access.
ISBN:	9781439809488 (ebook : 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 (ebook : PDF)Subjects--Topical Terms:

656158
Biomedical materials
--Testing.Index Terms--Genre/Form:

542853
Electronic books.

Safety evaluation in the development of medical devices and combination products
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092 $a 610.284 $b G123
100 1 $a Gad, Shayne C., $d 1948- $3 813897
245 1 0 $a Safety evaluation in the development of medical devices and combination products $h [electronic resource] / $c Shayne C. Gad, Marian G. McCord.
250 $a 3rd ed.
260 # $a New York : $b Informa Healthcare, $c c2008.
300 $a viii, 300 p. : $b ill.
500 $a Rev. ed. of: Safety evaluation of medical devices / Shayne Cox Gad. 2nd ed., Rev. and expanded. c2002.
504 $a Includes bibliographical references and index.
505 0 # $a 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.
530 $a Also available in print edition.
538 $a Mode of access: World Wide Web.
650 # 0 $a Biomedical materials $x Testing. $3 656158
650 # 0 $a Biomedical materials $x Toxicity testing. $3 915738
650 # 0 $a Biocompatibility $x Testing. $3 915737
655 # 7 $a Electronic books. $2 lcsh $3 542853
700 1 # $a McCord, Marian G. $3 1359999
700 1 # $a Gad, Shayne C., $d 1948- $3 813897
776 1 # $z 9781420071641
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776 1 # $z 9781439809488
856 4 0 $u http://marc.crcnetbase.com/isbn/9781439809488 $q application/PDF $z Distributed by publisher. Purchase or institutional license may be required for access.