An edition of Drug safety data: how to analyze and summarize safety data to determine risk
(2011)
Drug safety data
how to analyze and summarize safety data to determine risk
1st ed.
by Michael J. Klepper
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Drug safety data: how to analyze and summarize safety data to determine risk
2011, Jones and Bartlett Publishers, Jones & Bartlett Learning
in English
- 1st ed.
0763769126 9780763769123
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Book Details
Table of Contents
Benefit-risk
Begin at the end
The 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?
Adverse events that should be on everyone's radar screen
Exposure
Demographics and baseline characteristics
Disposition
Adverse events : common adverse events
Adverse events : deaths, other serious adverse events, other significant adverse events, analysis of adverse events by organ system or syndrome
Clinical laboratory tests : what is measured, what it means
Clinical laboratory tests : the analysis of laboratory data
Vital signs, physical findings, and other observations related to safety
Electrocardiograms
Safety in special groups and situations : intrinsic factors, extrinsic factors, 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.
Edition Notes
Includes bibliographical references and index.
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| June 4, 2022 | Edited by ImportBot | import existing book |
| August 1, 2020 | Edited by ImportBot | import existing book |
| May 1, 2010 | Created by WorkBot | work found |