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Bibliographic Record Display

• Title:Drug safety data : how to analyze, summarize, and interpret to determine risk / Michael J. Klepper, Barton Cobert.
  
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• Author/Creator:Klepper, Michael J.
  
• Other Contributors/Collections:Cobert, Barton L.
  
• Published/Created:Sudbury, MA : Jones and Bartlett Publishers, ©2011.
  

• Holdings

  Holdings Record Display

  • Location:WOODWARD LIBRARY stacksWhere is this?
    
  • Call Number: QZ42 .K64 2011
    
  • Number of Items:1
    
  • Status:Available
    

   
• Library of Congress Subjects:Pharmacoepidemiology.
  Health risk assessment.
  
• Medical Subjects: Pharmacoepidemiology--methods.
  Data Interpretation, Statistical.
  Drug Toxicity--prevention & control.
  Product Surveillance, Postmarketing.
  Risk Assessment.
  Safety Management.
  
• Edition:1st ed.
  
• Description:xix, 312 pages : ill ; 28 cm.
  
• Notes:Includes bibliographical references and index.
  
• ISBN:9780763769123
  0763769126
  
• Contents: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 baseline characteristics
  Disposition
  Adverse events part 1: common adverse events
  Adverse events part 2: deaths, other serious adverse events, other significant adverse events, 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.