000			02439cam a22004338i 4500
999			_c459 _d459
001			18207236
003			OSt
005			20181108132540.0
008			140630s2014 enk b 001 0 eng
010			_a 2014025599
020			_a9781119979661 (cloth)
035			_a(DNLM)101635803
040			_aDNLM/DLC _erda _cINAYA MEDICAL COLLEGE
041			_aENG
042			_apcc
050	0	0	_aR853.C55
060	1	0	_aQV 771
082	0	0	_a615.50724 GAS _223
100			_9378 _aGould,A. Lawrence
245	0	0	_aStatistical methods for evaluating safety in medical product development
263			_a1501
264		1	_aChichester, West Sussex, United Kingdom ; _aHoboken : _bJohn Wiley & Sons Inc., _c2014.
300			_ap. ; _ccm.
336			_atext _2rdacontent
337			_aunmediated _2rdamedia
338			_avolume _2rdacarrier
504			_aIncludes bibliographical references and index.
505	0		_aSafety graphics / A. Lawrence Gould -- QSAR modeling : prediction of biological activity from chemical structure / Andy Liaw and Vladimir Svetnik -- Ethical and practical issues in phase I trials in healthy volunteers / Stephen Senn -- Phase I trials / A. Lawrence Gould -- Summarizing adverse event risk / A. Lawrence Gould -- Statistical analysis of recurrent adverse events / Liqun Diao, Richard J. Cook, and Ker-Ai Lee -- Cardiovascular toxicity, especially QT/QTc prolongation / Arne Ring and Robert Schall -- Hepatic toxicity / Donald C. Trost -- Neurotoxicity / A. Lawrence Gould -- Safety monitoring / Jay Herson -- Sequential testing for safety evaluation / Jie Chen -- Evaluation of post-marketing safety using spontaneous reporting databases / Ismail Ahmed, Bernard Begaud, and Pascale Tubert-Bitter / Pharmacovigilance using observational/longitudinal databases and web-based information / A. Lawrence Gould.
650	1	2	_aDrug Evaluation _xmethods.
650	2	2	_aClinical Trials as Topic.
650	2	2	_aModels, Statistical.
650	2	2	_aPharmacovigilance.
650	2	2	_aSafety Management _xmethods.
650	2	2	_aTechnology, Pharmaceutical _xstandards.
700	1		_aGould, Lawrence _q(A. Lawrence), _eeditor.
776	0	8	_iOnline version: _tStatistical methods for evaluating safety in medical product development _dChichester, West Sussex, United Kingdom ; Hoboken : John Wiley & Sons Inc., 2014 _z9781118763094 _w(DLC) 2014026252
906			_a7 _bcbc _corignew _d1 _eecip _f20 _gy-gencatlg
942			_2ddc _cBK