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020 a| 9780470050941 (hbk.);

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245 00 a| Development and approval of combination productsh| [electronic resource] :b| a regulatory perspective /c| edited by Evan B. Siegel.;

260 a| Hoboken, N.J. :b| Wiley,;

300 a| xii, 215 p. :b| ill. ;c| 25 cm.;

504 a| Includes bibliographical references and index.;

505 0 a| Overview of combination products development and regulatory review / Evan B. Siegel -- Detailed regulatory approaches to development, review, and approval / James Barquest -- Nonclinical recommendations for successful characterization and development of combination drug products / Duane B. Lakings -- Clinical pharmacology and clinical development of combination products / Chaline Brown -- Regulatory strategy considerations for chemistry, manufacturing, and controls : an integrated approach / Patrick L. DeVillier.;

506 a| Available only to authorized users.;

538 a| Mode of access: World Wide Web;

610 10 a| United States.b| Food and Drug Administration.=| ^A1253;

610 12 a| United States.b| Food and Drug Administration.=| ^A1253;

650 0 a| Drug approvalz| United States.=| ^A1001108;

650 0 a| Biological productsz| United States.=| ^A132664;

650 0 a| Medical instruments and apparatusz| United States.=| ^A3247;

650 12 a| Drug Approvalx| legislation & jurisprudencez| United States.=| ^A1204660;

650 12 a| Drug Combinationsz| United States.=| ^A1098766;

650 22 a| Device Approvalx| legislation & jurisprudencez| United States.=| ^A1337250;

655 0 a| Electronic books.=| ^A491897;

700 1 a| Siegel, Evan B.=| ^A1048770;

856 40 z| Full text available from Ebook Central - Academic Completeu| https://ebookcentral.proquest.com/lib/eastcarolina/detail.action?docID=353455;

947 a| (OCoLC)ocn190867380;

947 a| (OCoLC)190867380;

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999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 4044768-2001l| HSLELECm| HSLr| Ys| Yt| HEBKu| 1/1/2016x| EBOOKz| HERESOURCE;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 4044768-3001l| MNETm| JMUSICr| Ys| Yt| MNESSBKu| 1/1/2016x| EBOOKz| JERESOURCE;

Development and approval of combination products a regulatory perspective / edited by Evan B. Siegel.

Other author	Siegel, Evan B.
Format	Electronic
Publication Info	Hoboken, N.J. : Wiley,
Description	xii, 215 p. : ill. ; 25 cm.
Supplemental Content	Full text available from Ebook Central - Academic Complete
Subjects	United States. Food and Drug Administration. United States. Food and Drug Administration. Drug approval--United States. Biological products--United States. Medical instruments and apparatus--United States. Drug Approval--legislation & jurisprudence. --United States. Drug Combinations--United States. Device Approval--legislation & jurisprudence. --United States.

Contents	Overview of combination products development and regulatory review / Evan B. Siegel -- Detailed regulatory approaches to development, review, and approval / James Barquest -- Nonclinical recommendations for successful characterization and development of combination drug products / Duane B. Lakings -- Clinical pharmacology and clinical development of combination products / Chaline Brown -- Regulatory strategy considerations for chemistry, manufacturing, and controls : an integrated approach / Patrick L. DeVillier.
Bibliography note	Includes bibliographical references and index.
Access restriction	Available only to authorized users.
Technical details	Mode of access: World Wide Web
Genre/form	Electronic books.
LCCN	2008001360
ISBN	9780470050941 (hbk.)

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Development and approval of combination products a regulatory perspective / edited by Evan B. Siegel.

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