english version

Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk

Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk
Preț: 598,50 lei
Disponibilitate: la comandă
ISBN: 9780763769123
Anul publicarii: 2011
Ediția: 5
Pagini: 316


Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk was selected for The First Clinical Research Bookshelf - Essential reading for clinical research professionals by the Journal of Clinical Research Best Practices.
The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for pre- and post-marketing risk assessment, providing drug safety/pharmacovogilance professionals, pharmaceutical and clinical research scientists, statisticians, programmers, medical writers, and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data.

With decades of pharmaceutical research and drug safety expertise, authors Dr. Klepper and Dr. Cobert discuss how quality planning, safety training, and data standardization result in significant cost, time, and resource savings. Through illustrative, step-by-step instruction, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is the definitive guide to drug safety data analysis and reporting.

Key Features Include:

  • Step-by-step instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reports
  • Pragmatic tips…and mistakes to avoid
  • Simple explanations of what safety data are collected, and what the data mean
  • Practical approaches to determining a drug effect and understanding its clinical significance
  • Guidance for determining risk throughout the lifecycle of a drug, biologic or nutraceutical
  • Examples of user-friendly data displays that enhance safety signal identification
  • Ways to improve data quality and reduce the time, resources and costs involved in mandatory safety reporting
  • Relevant material for the required training of drug safety/pharmacovigilance professionals
  • SPECIAL FEATURE: Actual examples of an Integrated Analysis of Safety (IAS) -used in the preparation of the Integrated Summary of Safety (ISS) and the Summary of Clinical Safety (SCS) reports -, and the Periodic Safety Update Report (PSUR)
  • Part  1  The Basics
  •   Chapter  1  Benefit-Risk
  •   Chapter  2  Begin at the End
  •   Chapter  3  The "Dynamic" Integrated Safety Database - Something You Shouldn't Live Without
  •   Chapter  4  Coding Basics
  •   Chapter  5  Determining Causality - The Individual Case Safety Report
  •   Chapter  6  Determining Causality - Aggregate Data
  •   Chapter  7  Determining the Weight of Evidence - Patterns and Links
  •   Chapter  8  Determining Clinical Significance... and Then What?
  •   Chapter  9  Clinical Laboratory Tests - What Is Measured; What It Means
  •   Chapter  10  12-Lead Electrocardiograms - What Is Measured; What It Means
  •   Chapter  11  Adverse Events That Should Be on Everyone's Radar Screen
  • Part  2  Approaches to the Analysis, Summary, and Interpretation of Safety Data
  •   Chapter  12  Exposure
  •   Chapter  13  Demographics and Other Baseline Characteristics
  •   Chapter  14  Disposition
  •   Chapter  15  Adverse Events Part 1: Common Adverse Events
  •   Chapter  16  Adverse Events Part 2: Deaths, Other Serious Adverse Events, Other Significant Adverse Events, and Analysis of Adverse Events by Organ System or Syndrome
  •   Chapter  17  The Analysis of Laboratory Data
  •   Chapter  18  The Analysis of Vital Signs, Physical Findings, and Other Observations Related to Safety
  •   Chapter  19  The Analysis of Electrocardiograms
  •   Chapter  20  Safety in Special Groups and Situations - Intrinsic Factors, Extrinsic Factors, and Drug Interactions
  •   Chapter  21  Use in Pregnancy and Lactation
  •   Chapter  22  Overdose
  •   Chapter  23  Drug Abuse
  •   Chapter  24  Withdrawl and Rebound
  •   Chapter  25  Effects on Ability to Drive or Operate Machinery or Impairment of Mental Ability
  •   Appendix  1  Introducing Mepro - A Fictitious Drug
  •   Appendix  2  The Integrated Analysis of Safety for Mepro
  •   Appendix  3  Company Core Safety Information for MEPRO (Meproamine Dihydroacetate)
  •   Appendix  4  6-Month Periodic Safety Update Report - Mepro
  •   Appendix  5  Clinically Significant Criteria for Laboratory, Vital Signs, Body Weight, Body Mass Index, and Electrocardiogram Parameters


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