000			02030nam a22003854a 4500
001			ebr10296672
003			CaPaEBR
006			m u
007			cr cn|||||||||
008			080110s2008 njua sb 001 0 eng
010			_z 2008001360
016	7		_z101463351 _2DNLM
020			_z9780470050941 (hbk.)
040			_aCaPaEBR _cCaPaEBR
035			_a(OCoLC)647764606
043			_an-us---
050	1	4	_aRA401.5 _b.D48 2008eb
082	0	4	_a363.19/46 _222
090			_c101122 _d80999
245	0	0	_aDevelopment and approval of combination products _h[electronic resource] : _ba regulatory perspective / _cedited by Evan B. Siegel.
260			_aHoboken, N.J. : _bWiley, _cc2008.
300			_axii, 215 p. : _bill. ; _c25 cm.
504			_aIncludes bibliographical references and index.
505	0		_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.
533			_aElectronic reproduction. _bPalo Alto, Calif. : _cebrary, _d2009. _nAvailable via World Wide Web. _nAccess may be limited to ebrary affiliated libraries.
610	1	0	_aUnited States. _bFood and Drug Administration.
610	1	2	_aUnited States. _bFood and Drug Administration.
650		0	_aDrug approval _zUnited States.
650		0	_aBiological products _zUnited States.
650		0	_aMedical instruments and apparatus _zUnited States.
655		7	_aElectronic books. _2local
700	1		_aSiegel, Evan B.
710	2		_aebrary, Inc.
856	4	0	_uhttp://site.ebrary.com/lib/strathmore/Doc?id=10296672 _zAn electronic book accessible through the World Wide Web; click to view
999			_c101122 _d80999