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

Jones & Bartlett Learning
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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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Additional Information

Publisher
Jones & Bartlett Learning
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Published on
Oct 25, 2010
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Pages
312
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ISBN
9780763769123
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Best For
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Language
English
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Genres
Medical / Clinical Medicine
Medical / Drug Guides
Medical / Epidemiology
Medical / Health Risk Assessment
Medical / Pharmacology
Medical / Physician & Patient
Medical / Reference
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Content Protection
This content is DRM protected.
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Charles E. Rosenberg
Cholera was the classic epidemic disease of the nineteenth century, as the plague had been for the fourteenth. Its defeat was a reflection not only of progress in medical knowledge but of enduring changes in American social thought. Rosenberg has focused his study on New York City, the most highly developed center of this new society. Carefully documented, full of descriptive detail, yet written with an urgent sense of the drama of the epidemic years, this narrative is as absorbing for general audiences as it is for the medical historian. In a new Afterword, Rosenberg discusses changes in historical method and concerns since the original publication of The Cholera Years.

"A major work of interpretation of medical and social thought . . . this volume is also to be commended for its skillful, absorbing presentation of the background and the effects of this dread disease."—I.B. Cohen, New York Times

"The Cholera Years is a masterful analysis of the moral and social interest attached to epidemic disease, providing generally applicable insights into how the connections between social change, changes in knowledge and changes in technical practice may be conceived."—Steven Shapin, Times Literary Supplement

"In a way that is all too rarely done, Rosenberg has skillfully interwoven medical, social, and intellectual history to show how medicine and society interacted and changed during the 19th century. The history of medicine here takes its rightful place in the tapestry of human history."—John B. Blake, Science
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