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.