Drug safety data : how to analyze, summarize, and interpret to determine risk / Michael J. Klepper, Barton Cobert.
| Author/creator | Klepper, Michael J. |
| Other author | Cobert, Barton L. |
| Format | Book |
| Edition | 1st ed. |
| Publication Info | Sudbury, MA : Jones and Bartlett Publishers, ©2011. |
| Description | xix, 312 pages : illustrations ; 28 cm |
| Subjects |
| 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. |
| Local note | Laupus-WCP |
| Bibliography note | Includes bibliographical references and index. |
| LCCN | 2010005220 |
| ISBN | 9780763769123 |
| ISBN | 0763769126 |
Availability
| Library | Location | Call Number | Status | Item Actions |
|---|---|---|---|---|
| Laupus | Books - Stacks | QZ 42 K64D 2011 | ✔ Available | Place Hold |