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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About the author

President, Michael J. Klepper, MD, LLC, Research Triangle Park, North Carolina

President, BLCMD Associates LLC, Westfield, New Jersey

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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 / Reference
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Content Protection
This content is DRM protected.
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The anthrax envelopes incident in the United States in 2001 created the impetus for a substantial increase in preparedness for bioterrorist threats among both public health and law enforcement professionals, worldwide. Ever increasing resources are now being allocated for dealing with a wide variety of potential threats, from the reintroduction of eradicated viruses such as smallpox to the possibility of genetically engineered novel pathogens. Despite the potentially devastating consequences of the various projected bioterror scenarios, it remains remarkably difficult to quantitatively assess the actual risk in each of these scenarios. Nevertheless, such risk assessment is crucial for determining the appropriate allocation of resources for research and preparedness.

The public anxiety expected during a large-scale bioterrorism attack may even be more damaging than the direct effects of the bioterrorism agent, both in health-related and economic outcomes. Carefully tailored risk communication is a major tool for individuals, decision-makers or even entire communities to make educated decisions about their responses to well-being, and avoid social disruption.

In this book, we have included articles from leading experts in the various disciplines associated with risk assessment and risk communication associated with bioterrorism. These papers are based on presentations at a NATO Advanced Research Workshop in Israel in June 2005, which addressed these issues. The resulting volume integrates the viewpoints of public health, law enforcement, risk analysis and media experts into a comprehensive, practical guide for approaching risk assessment and risk communication in a bioterrorism event.

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The second edition of Traditional Chinese Medicines includes 2300 new compounds, 2400 additional plant sources, more CAS Registry Numbers, and more pharmacological data. The structure of the book has been extensively reorganised to make cross referencing the data much simpler. This new edition is therefore a substantial improvement on the first edition of this important reference on the structural chemistry of traditional Chinese medicines.
Scientists agree that a pathogen is likely to cause a global pandemic in the near future. But which one? And how?

Over the past fifty years, more than three hundred infectious diseases have either newly emerged or reemerged, appearing in territories where they’ve never been seen before. Ninety percent of epidemiologists expect that one of them will cause a deadly pandemic sometime in the next two generations. It could be Ebola, avian flu, a drug-resistant superbug, or something completely new. While we can’t know which pathogen will cause the next pandemic, by unraveling the story of how pathogens have caused pandemics in the past, we can make predictions about the future. In Pandemic: Tracking Contagions, from Cholera to Ebola and Beyond, the prizewinning journalist Sonia Shah—whose book on malaria, The Fever, was called a “tour-de-force history” (The New York Times) and “revelatory” (The New Republic)—interweaves history, original reportage, and personal narrative to explore the origins of contagions, drawing parallels between cholera, one of history’s most deadly and disruptive pandemic-causing pathogens, and the new diseases that stalk humankind today.

To reveal how a new pandemic might develop, Sonia Shah tracks each stage of cholera’s dramatic journey, from its emergence in the South Asian hinterlands as a harmless microbe to its rapid dispersal across the nineteenth-century world, all the way to its latest beachhead in Haiti. Along the way she reports on the pathogens now following in cholera’s footsteps, from the MRSA bacterium that besieges her own family to the never-before-seen killers coming out of China’s wet markets, the surgical wards of New Delhi, and the suburban backyards of the East Coast.

By delving into the convoluted science, strange politics, and checkered history of one of the world’s deadliest diseases, Pandemic reveals what the next global contagion might look like— and what we can do to prevent it.

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