MARC Record from Library of Congress

LEADER: 02530cam a22003974a 4500
001 2010005220
003 DLC
005 20110304125226.0
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 00 $aRM302.5$b.K64 2011
060 00 $a2010 L-157
060 10 $aQZ 42$bK64d 2011
082 00 $a615/.7042$222
100 1 $aKlepper, Michael J.
245 10 $aDrug safety data :$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 12 $aPharmacoepidemiology$xmethods.
650 22 $aData Interpretation, Statistical.
650 22 $aDrug Toxicity$xprevention & control.
650 22 $aProduct Surveillance, Postmarketing.
650 22 $aRisk Assessment.
650 22 $aSafety Management.
700 1 $aCobert, Barton L.