000			02681cam a22004454a 4500
001			16092186
003			OSt
005			20250903112541.0
008			100205s2011 maua b 001 0 eng
010			_a 2010005220
016	7		_a101524189 _2DNLM
020			_a9780763769123
020			_a0763769126
035			_a(OCoLC)ocn520439540
040			_aDNLM/DLC _cDLC _dNLM _dYDXCP _dC#P _dCDX _dDLC
042			_apcc
050	0	0	_aRM 302.5 .K64 2011
060	0	0	_a
060	1	0	_a _b
082	0	0	_a _2
100	1		_aKlepper, Michael J.
245	1	0	_aDrug safety data : _bhow to analyze, summarize, and interpret to determine risk / _cMichael J. Klepper, Barton Cobert.
250			_a1st ed.
260			_aSudbury, MA : _bJones & Bartlett Learning, _cc2011.
300			_axix, 312 p. : _bill. ; _c28 cm.
504			_aIncludes bibliographical references and index.
505	0		_aBenefit-risk -- Begin at the end -- The dynamic integrated safety database--something you shouldn't live without -- Coding basics -- Determining causality--the individual case safety report -- Determining causality--aggregate data -- Determining the weight of evidence--patterns and links -- Determining clinical significance-- and then what? -- Clinical laboratory tests--what is measured; what it means -- 12 lead electrocardiograms--what is measures; what it means -- Adverse events that should be on everyone's radar screen -- Exposure -- Demographics and other baseline characteristics -- Disposition -- Adverse events part 1 : common adverse events -- Adverse events part 2 : deaths, other serious adverse events, other significant adverse events, and analysis of adverse events by organ system or syndrome -- The analysis of laboratory data -- The analysis of vital signs, physical findings, and other observations related to safety -- The analysis of electrocardiograms data -- Safety in special groups and situations--intrinsic factors, extrinsic factors, and drug interactions -- Use in pregnancy and lactation -- Overdose -- Drug abuse -- Withdrawal and rebound -- Effects on ability to drive or operate machinery or impairment of mental ability.
650		0	_aPharmacoepidemiology.
650		0	_aHealth risk assessment.
650	1	2	_aPharmacoepidemiology _xmethods.
650	2	2	_aData Interpretation, Statistical.
650	2	2	_aDrug Toxicity _xprevention & control.
650	2	2	_aProduct Surveillance, Postmarketing.
650	2	2	_aRisk Assessment.
650	2	2	_aSafety Management.
700	1		_aCobert, Barton L.
906			_a7 _bcbc _corignew _d1 _eecip _f20 _gy-gencatlg
942			_2lcc _cBK _n0
999			_c521 _d521