000			01816nam a2200373Ia 4500
001			CRC00E64460PDF
003			BD-DhSAU
005			20151012144300.0
006			m|||||o||d||||||||
007			cr||||
008			071016s2008 flua sb 001 0 eng d
020			_a9781420064513 (ebook : PDF)
040			_aBD-DhSAU _cBD-DhSAU
043			_an-us---
060	1	0	_aQV 26 _bG659c 2008
090			_aRM301.27 _b.G68 2008
092			_a615.1 _bG659
100	1		_aGopalaswamy, Smita.
245	1	0	_aCombination products _h[electronic resource] : _bregulatory challenges and successful product developement / _cSmita Gopalaswamy and Venky Gopalaswamy.
260			_aBoca Raton, Fla. : _bTaylor & Francis, _c2008.
300			_axvi, 241 p. : _bill.
504			_aIncludes bibliographical references and index.
505	0		_aOverview and definitions of combination products -- Ensuring successful development -- Overview of FDA and other regulatory agency expectations -- Resource requirements -- Manufacturing of combination products -- Challenges and pitfalls to avoid with combination products -- Post launch compliance requirements -- Agency audits and challenges.
530			_aAlso available in print edition. _bCRC Press (http://www.crcpress.com)
538			_aMode of access: World Wide Web.
610	1	0	_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.
655		7	_aElectronic books. _2lcsh
700	1		_aGopalaswamy, Venky.
776	1		_z9781420064469
856	4	0	_uhttp://marc.crcnetbase.com/isbn/9781420064513 _qapplication/PDF
999			_c11173 _d11172