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Drug Safety Data: How To Analyze, Summarize And Interpret To Determine Risk (Paperback)
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Drug Safety Data: How To Analyze, Summarize And Interpret To Determine Risk (Paperback)
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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. Drug Safety
Data: How to Analyze, Summarize and Interpret to Determine Risk
provides 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. 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.
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)
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