000			01610cam a22003974a 4500
001			15979121
003			IIITD
005			20160901145133.0
008			091104s2010 nju b 001 0 eng
010			_a 2009045887
015			_aGBB049483 _2bnb
016	7		_a101518888 _2DNLM
016	7		_a015529425 _2Uk
020			_a9780470602256
035			_a(OCoLC)ocn465378651
040			_aDNLM/DLC _cDLC _dYDX _dNLM _dYDXCP _dUKM _dCDX _dDLC
042			_apcc
050	0	0	_aR856.4 _b.A22 2010
060	0	0	_a2010 J-282
060	1	0	_aW 26 _bA135d 2010
082	0	0	_a610.28 _222 _bABD-D
100	1		_aAbdel-aleem, Salah.
245	1	4	_aDesign and management of medical device clinical trials : _bstrategies and challenges _cSalah Abdel-aleem.
260			_aHoboken, N.J. : _bWiley, _c©2010.
300			_axvii, 250 p. ; _c25 cm.
504			_aIncludes bibliographical references and index.
505	0		_aChallenges to the design of clinical study -- Challenges to managing the study -- Selection of historic controls -- Fraud and misconduct in clinical trials -- Challenges to the regulation of medical device -- Challenges of global clinical studies and the CE mark process -- Challenging FDA PMA cases -- Bioethics in clinincal research.
650		0	_aMedical instruments and apparatus _xResearch.
650		0	_aClinical trials.
650	1	2	_aClinical Trials as Topic _xmethods.
650	1	2	_aEquipment and Supplies.
650	2	2	_aDevice Approval.
906			_a7 _bcbc _corignew _d1 _eecip _f20 _gy-gencatlg
942			_2ddc _cBK
999			_c13073 _d13073