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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

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Safety evaluation in the development of medical devices and combination products/ Shayne C. Gad, Marian G. McCord.
作者:	Gad, Shayne C.,
其他作者:	McCord, Marian G.
出版者:	New York :Informa Healthcare, : c2008.,
面頁冊數:	viii, 300 p. :ill.
附註:	Rev. ed. of: Safety evaluation of medical devices / Shayne Cox Gad. 2nd ed., Rev. and expanded. c2002.
內容註:	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.
標題:	Biomedical materials - Testing. -
電子資源:	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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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.
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650 # 0 $a Biocompatibility $x Testing. $3 915737
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700 1 # $a Gad, Shayne C., $d 1948- $3 813897
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