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000425034 010__ $$z  2008001360
000425034 0167_ $$z101463351$$2DNLM
000425034 020__ $$z9780470050941 (hbk.)
000425034 035__ $$a(CaPaEBR)ebr10296672
000425034 035__ $$a(OCoLC)647764606
000425034 040__ $$aCaPaEBR$$cCaPaEBR
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000425034 05014 $$aRA401.5$$b.D48 2008eb
000425034 08204 $$a363.19/46$$222
000425034 24500 $$aDevelopment and approval of combination products$$h[electronic resource] :$$ba regulatory perspective /$$cedited by Evan B. Siegel.
000425034 260__ $$aHoboken, N.J. :$$bWiley,$$cc2008.
000425034 300__ $$axii, 215 p. :$$bill. ;$$c25 cm.
000425034 504__ $$aIncludes bibliographical references and index.
000425034 5050_ $$aOverview 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.
000425034 506__ $$aAccess limited to authorized users.
000425034 61010 $$aUnited States.$$bFood and Drug Administration.
000425034 650_0 $$aDrug approval$$zUnited States.
000425034 650_0 $$aBiological products$$zUnited States.
000425034 650_0 $$aMedical instruments and apparatus$$zUnited States.
000425034 655_7 $$aElectronic books.$$2lcsh
000425034 7001_ $$aSiegel, Evan B.
000425034 852__ $$bebk
000425034 85640 $$3ProQuest Ebook Central Academic Complete$$uhttps://univsouthin.idm.oclc.org/login?url=http://site.ebrary.com/lib/usiricelib/Doc?id=10296672$$zOnline Access
000425034 909CO $$ooai:library.usi.edu:425034$$pGLOBAL_SET
000425034 980__ $$aEBOOK
000425034 980__ $$aBIB
000425034 982__ $$aEbook
000425034 983__ $$aOnline