000			01617cam a2200337 a 4500
005			20250918004327.0
008			090224s2008 flua b 001 0 eng
020			_a9781420064469 (hardcover : alk. paper)
020			_a1420064460 (hardcover : alk. paper)
039		9	_a200903170923 _bruzini _y02-24-2009 _zratnab
040			_aUKM
060			_aQV26 _b.G659c 2008 9
090			_aQV26.G659c 2008 9
100	1		_aGopalaswamy, Smita
245	1	0	_aCombination products : _bregulatory challenges and successful product developement / _cSmita Gopalaswamy, Venky Gopalaswamy
260			_aBoca Raton : _bCRC Press, _c2008
300			_axvi, 241 p. : _bill. ; _c25 cm.
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
650		2	_aEquipment Design _xstandards _zUnited States
650		2	_aPharmaceutical Preparations _xstandards _zUnited States
650		2	_aBiological Products _xstandards _zUnited States
650		2	_aDevice Approval _xstandards _zUnited States
650		2	_aEquipment and Supplies _xstandards _zUnited States
700	1		_aGopalaswamy, Venky
907			_a.b1442552x _b2019-11-12 _c2019-11-12
942			_c01 _n0 _kQV26.G659c 2008 9
914			_avtls003401737
991			_aJabatan Bioperubatan, KKL
998			_ad _b2009-11-02 _cm _da _feng _gflu _y0 _z.b1442552x
999			_c435127 _d435127