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Combination products = regulatory challenges and successful product developement /

Record Type:	Language materials, printed : 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:	Equipment and Supplies - standards - United States. -
Online resource:	https://www.taylorfrancis.com/books/9780429149832
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:

798609
United States.
Food and Drug Administration.Subjects--Topical Terms:

582872
Equipment and Supplies
--standards--United States.Index Terms--Genre/Form:

554714
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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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.
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