Drug safety data
Subtitle: how to analyze, summarize, and interpret to determine risk
By: Michael J. Klepper, Barton Cobert
Contributors: Cobert, Barton L.
Edition: 1st ed.
Publisher: Jones & Bartlett Learning
Published: 2011
Place of publication: Sudbury, MA
Language: eng
Number of pages: 312
ISBN-13: 9780763769123
Subjects: Pharmacoepidemiology; Safety Management; Postmarketing Product Surveillance; Health risk assessment; Risk Assessment; Statistical Data Interpretation; Drug Toxicity; Prevention & control; Methods
Notes: Includes bibliographical references and index.
Table of contents: title: Benefit-risk; title: Begin at the end; title: The dynamic integrated safety database; title: something you shouldn't live without; title: Coding basics; title: Determining causality; title: the individual case safety report; title: Determining causality; title: aggregate data; title: Determining the weight of evidence; title: patterns and links; title: Determining clinical significance; title: and then what?; title: Clinical laboratory tests; title: what is measured; what it means; title: 12 lead electrocardiograms; title: what is measures; what it means; title: Adverse events that should be on everyone's radar screen; title: Exposure; title: Demographics and other baseline characteristics; title: Disposition; title: Adverse events part 1 : common adverse events; title: Adverse events part 2 : deaths, other serious adverse events, other significant adverse events, and analysis of adverse events by organ system or syndrome; title: The analysis of laboratory data; title: The analysis of vital signs, physical findings, and other observations related to safety; title: The analysis of electrocardiograms data; title: Safety in special groups and situations; title: intrinsic factors, extrinsic factors, and 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.