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Combination products = regulatory challenges and successful product developement /

Record Type:	Electronic resources : Monograph/item
Title/Author:	Combination products/ Smita Gopalaswamy and Venky Gopalaswamy.
Reminder of title:	regulatory challenges and successful product developement /
Author:	Gopalaswamy, Smita.
other author:	Gopalaswamy, Venky.
Published:	Boca Raton :CRC Press, : c2008.,
Description:	1 online resource (1 v.)
Subject:	Drugs - Standards - United States. -
Online resource:	http://www.crcnetbase.com/isbn/9781420064469
ISBN:	9781420064513 (electronic bk.)

Combination products = 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:

758649
United States.
Food and Drug Administration.Subjects--Topical Terms:

915787
Drugs
--Standards--United States.Index Terms--Genre/Form:

542853
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 = 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 758649
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650 0 $a Medical instruments and apparatus $x Standards $z United States. $3 2018848
650 0 $a Biological products $x Standards $z United States. $3 2018849
650 1 2 $a Equipment Design $x standards $z United States. $3 2018850
650 1 2 $a Pharmaceutical Preparations $x standards $z United States. $3 916154
650 2 2 $a Biological Products $x standards $z United States. $3 916152
650 2 2 $a Device Approval $x standards $z United States. $3 2018851
650 2 2 $a Equipment and Supplies $x standards $z United States. $3 916153
655 4 $a Electronic books. $2 lcsh $3 542853
700 1 $a Gopalaswamy, Venky. $3 916262
856 4 0 $u http://www.crcnetbase.com/isbn/9781420064469