Drug safety data : how to analyze, summarize, and interpret to determine risk /
Klepper, Michael J.
Drug safety data : how to analyze, summarize, and interpret to determine risk / Michael J. Klepper, Barton Cobert. - 1st ed. - Sudbury, MA : Jones & Bartlett Learning, c2011. - xix, 312 p. : ill. ; 28 cm.
Includes bibliographical references and index.
Benefit-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.
9780763769123 0763769126
2010005220
101524189 DNLM
Pharmacoepidemiology.
Health risk assessment.
Pharmacoepidemiology--methods.
Data Interpretation, Statistical.
Drug Toxicity--prevention & control.
Product Surveillance, Postmarketing.
Risk Assessment.
Safety Management.
RM 302.5 .K64 2011
/
Drug safety data : how to analyze, summarize, and interpret to determine risk / Michael J. Klepper, Barton Cobert. - 1st ed. - Sudbury, MA : Jones & Bartlett Learning, c2011. - xix, 312 p. : ill. ; 28 cm.
Includes bibliographical references and index.
Benefit-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.
9780763769123 0763769126
2010005220
101524189 DNLM
Pharmacoepidemiology.
Health risk assessment.
Pharmacoepidemiology--methods.
Data Interpretation, Statistical.
Drug Toxicity--prevention & control.
Product Surveillance, Postmarketing.
Risk Assessment.
Safety Management.
RM 302.5 .K64 2011
/