MARC View

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003			KUKTEM
005			20251117144412.0
008			100705t2008 flua f b 001 0 eng d
020			_a9781420064469 (hardcover : alk. paper)
020			_a1420064460 (hardcover : alk. paper)
039		9	_a201107131934 _bVLOAD _c201106031148 _dFida _c201011021700 _dfauzi _y201007051417 _zshikin
040			_aUMP
090			_aRM301.27 .G67 2008
100	1		_aGopalaswamy, Smita
245	1	0	_aCombination products : _bregulatory challenges and successful product developement / _cSmita Gopalaswamy, Venky Gopalaswamy
260			_aBoca Raton : _bCRC Press, _cc2008
300			_axvi, 241 p. : _bill. ; _c25 cm.
504			_aIncludes bibliographical references and index
505	0		_aOverview of combination products -- Ensuring successful combination product development -- Overview of FDA and other regulatory agency expectations -- Resource requirements -- Manufacturing of combination products -- Challenges and pitfalls to avoid with combination products -- Postlaunch compliance requirements -- Agency audits and challenges
610	1	0	_aUnited States _bFood and Drug Administration
610	1	2	_aUnited States _bFood and Drug Administration
650		0	_aDrugs _xStandards _zUnited States
650		0	_aMedical instruments and apparatus _xStandards _zUnited States
650		0	_aBiological products _xStandards _zUnited States
650	1	2	_aEquipment Design _xstandards _zUnited States
650	1	2	_aPharmaceutical Preparations _xstandards _zUnited States
650	2	2	_aBiological Products _xstandards _zUnited States
650	2	2	_aDevice Approval _xstandards _zUnited States
650	2	2	_aEquipment and Supplies _xstandards _zUnited States
700	1		_aGopalaswamy, Venky
856	4	1	_3Table of contents only _uhttp://www.loc.gov/catdir/toc/ecip082/2007043090.html
999			_aVIRTUA40 _c35588 _d35594
999			_aVTLSSORT00800200020104000900100024502600300050405050610061016500650165026503650465056506650770008560*9991