Drug safety data
Subtitle: how to analyze and summarize safety data to determine risk
By: Michael J. Klepper, Barton Cobert.
Contributors: Cobert, Barton L.
Edition: 1st ed.
Publisher: Jones and Bartlett Publishers; Jones & Bartlett Learning
Published: 2011
Place of publication: Sudbury, Mass
Language: eng
Number of pages: 312
ISBN-13: 9780763769123
Subjects: Pharmacoepidemiology; Health risk assessment; Pharmacoepidemiology -- methods; Data Interpretation, Statistical; Drug Toxicity -- prevention & control; Product Surveillance, Postmarketing; Risk Assessment; Safety Management
Notes: Includes bibliographical references and index.
Table of contents: title: Benefit-risk; title: Begin at the end; title: The integrated safety database : something you shouldn't live without; title: Coding basics; title: Determining causality : the individual case safety report; title: Determining causality : aggregate data; title: Determining the "weight of evidence" patterns and links; title: Determining clinical significance : and then what?; title: Adverse events that should be on everyone's radar screen; title: Exposure; title: Demographics and baseline characteristics; title: Disposition; title: Adverse events : common adverse events; title: Adverse events : deaths, other serious adverse events, other significant adverse events, analysis of adverse events by organ system or syndrome; title: Clinical laboratory tests : what is measured, what it means; title: Clinical laboratory tests : the analysis of laboratory data; title: Vital signs, physical findings, and other observations related to safety; title: Electrocardiograms; title: Safety in special groups and situations : intrinsic factors, extrinsic factors, drug interactions; title: Use in pregnancy and lactation; title: Overdose; title: Drug abuse; title: Withdrawal and rebound; title: Effects on ability to drive or operate machinery or impairment of mental ability.