東華大學圖書館 |

語系: 繁體中文

說明(常見問題)

回圖書館首頁

手機版館藏查詢

登入

回首頁

切換: 標籤 | MARC模式 | ISBD

FindBook

Google Book

Amazon

博客來

Combination products = regulatory challenges and successful product developement /

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Combination products/ Smita Gopalaswamy and Venky Gopalaswamy.
其他題名:	regulatory challenges and successful product developement /
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. -
電子資源:	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 /
LDR:01544cmm a2200265Ia 4500 001 1902453
006 m o d
007 cr cnu---unuuu
008 140127s2008 flu ob 001 0 eng d
020 $a 9781420064513 (electronic bk.)
020 $a 1420064517 (electronic bk.)
020 $z 9781420064469
035 $a ocn221704687
035 $a 1902453
040 $a N $b eng $c N $d OCLCQ $d STF $d OCLCQ $d MERUC $d OCLCQ $d OCLCA
043 $a n-us---
050 4 $a RM301.27 $b .G68 2008eb
060 4 $a QV 26 $b G659c 2008
082 0 4 $a 615/.1 $2 22
100 1 $a Gopalaswamy, Smita. $3 2018847
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
650 0 $a Drugs $x Standards $z United States. $3 915787
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