| Edition |
First edition. |
| Description |
1 online resource (xix, 312 pages) : illustrations |
| Bibliography |
Includes bibliographical references and index. |
| 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. |
| Note |
Description based on print version record. |
|
GMD: electronic resource. |
| Subject |
Pharmacoepidemiology.
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Health risk assessment.
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Pharmacoepidemiology -- methods.
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Data Interpretation, Statistical.
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Drug-Related Side Effects and Adverse Reactions -- prevention & control.
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Product Surveillance, Postmarketing.
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Risk Assessment.
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Safety Management.
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| Added Author |
Cobert, Barton L.
|
| Other Form: |
Print version: Klepper, Michael J. Drug safety data. 1st ed. Sudbury, MA : Jones and Bartlett Publishers, c2011 9780763769123 (DLC) 2010005220 (OCoLC)520439540 |
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