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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/978-1-4200-6446-9
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:

201310
United States.
Food and Drug Administration.Subjects--Topical Terms:

270046
Drugs
--Standards--United States.Index Terms--Genre/Form:

96803
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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