TY  - BOOK
AU  - Klepper,Michael J.
AU  - Cobert,Barton L.
TI  - Drug safety data: how to analyze, summarize, and interpret to determine risk 
SN  - 9780763769123
AV  - RM 302.5 .K64 2011 
U1  -    
PY  - 2011///
CY  - Sudbury, MA
PB  - Jones & Bartlett Learning
KW  - Pharmacoepidemiology
KW  - Health risk assessment
KW  - methods
KW  - Data Interpretation, Statistical
KW  - Drug Toxicity
KW  - prevention & control
KW  - Product Surveillance, Postmarketing
KW  - Risk Assessment
KW  - Safety Management
N1  - Includes bibliographical references and index; 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 other baseline characteristics -- Disposition -- Adverse events part 1 : common adverse events -- Adverse events part 2 : deaths, other serious adverse events, other significant adverse events, and 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
ER  -