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Combination products[electronic reso...

Gopalaswamy, Smita.

Combination products[electronic resource] :regulatory challenges and successful product developement /

紀錄類型:	書目-語言資料,印刷品 : Monograph/item
杜威分類號:	615/.1
書名/作者:	Combination products : regulatory challenges and successful product developement // Smita Gopalaswamy and Venky Gopalaswamy.
作者:	Gopalaswamy, Smita.
其他作者:	Gopalaswamy, Venky.
出版者:	Boca Raton : : CRC Press,, c2008.
面頁冊數:	1 online resource (1 v.)
標題:	Drugs - Standards - United States.
標題:	Medical instruments and apparatus - Standards - United States.
標題:	Biological products - Standards - United States.
標題:	Equipment Design - standards - United States.
標題:	Pharmaceutical Preparations - standards - United States.
標題:	Biological Products - standards - United States.
標題:	Device Approval - standards - United States.
標題:	Equipment and Supplies - standards - United States.
ISBN:	9781420064513 (electronic bk.)
ISBN:	1420064517 (electronic bk.)
書目註:	Includes bibliographical references and index.
摘要、提要註:	The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part individually, there are very few publications, including FDA documents, available concerning the unique challenges posed by this nascent but fast-growing area. Providing the first in-depth look at this breakthrough field, Combination Products includes practical guidelines and a detailed step-by-step process for the development of these novel technologies. It addresses the technical, scientific, regulatory, and quality iss.
電子資源:	http://www.crcnetbase.com/isbn/978-1-4200-6446-9

Combination products[electronic resource] :regulatory challenges and successful product developement /
Gopalaswamy, Smita.

Combination productsregulatory challenges and successful product developement /[electronic resource] :Smita Gopalaswamy and Venky Gopalaswamy. - Boca Raton :CRC Press,c2008. - 1 online resource (1 v.)

Includes bibliographical references and index.

The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part individually, there are very few publications, including FDA documents, available concerning the unique challenges posed by this nascent but fast-growing area. Providing the first in-depth look at this breakthrough field, Combination Products includes practical guidelines and a detailed step-by-step process for the development of these novel technologies. It addresses the technical, scientific, regulatory, and quality iss.

ISBN: 9781420064513 (electronic bk.)Subjects--Corporate Names:

448067
United States.
Food and Drug Administration.Subjects--Topical Terms:

559528
Drugs
--Standards--United States.Index Terms--Genre/Form:

336502
Electronic books.

LC Class. No.: RM301.27 / .G68 2008eb

Dewey Class. No.: 615/.1

National Library of Medicine Call No.: QV 26 / G659c 2008

Combination products[electronic resource] :regulatory challenges and successful product developement /
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245 1 0 $a Combination products $h [electronic resource] : $b regulatory challenges and successful product developement / $c Smita Gopalaswamy and Venky Gopalaswamy.
260 $a Boca Raton : $b CRC Press, $c c2008.
300 $a 1 online resource (1 v.)
504 $a Includes bibliographical references and index.
520 $a The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part individually, there are very few publications, including FDA documents, available concerning the unique challenges posed by this nascent but fast-growing area. Providing the first in-depth look at this breakthrough field, Combination Products includes practical guidelines and a detailed step-by-step process for the development of these novel technologies. It addresses the technical, scientific, regulatory, and quality iss.
588 $a Description based on print version record.
610 1 0 $a United States. $b Food and Drug Administration. $3 448067
650 0 $a Drugs $x Standards $z United States. $3 559528
650 0 $a Medical instruments and apparatus $x Standards $z United States. $3 559529
650 0 $a Biological products $x Standards $z United States. $3 559530
650 1 2 $a Equipment Design $x standards $z United States. $3 559531
650 1 2 $a Pharmaceutical Preparations $x standards $z United States. $3 448089
650 2 2 $a Biological Products $x standards $z United States. $3 438234
650 2 2 $a Device Approval $x standards $z United States. $3 559532
650 2 2 $a Equipment and Supplies $x standards $z United States. $3 438235
655 4 $a Electronic books. $2 local $3 336502
700 1 $a Gopalaswamy, Venky. $3 559527
856 4 0 $u http://www.crcnetbase.com/isbn/978-1-4200-6446-9

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