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

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

Author: Michael J. Klepper

Publisher: Jones & Bartlett Publishers

Published: 2010-09-15

Total Pages: 332

ISBN-13: 1449671551

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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)


501 Great Artists

501 Great Artists

Author: Geoff Dyer

Publisher: Apple Press

Published: 2009

Total Pages: 640

ISBN-13: 9781845433116

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Great art has the power to express emotions, to provoke arguments, to change the way we see the world, or simply to entertain. 501 Great Artists is a comprehensive, single-volume guide to the artists down the centuries who have influenced our world through their art and whose achievements have shaped the course of art history. Students of art and non-specialist readers alike will find 501 Great Artists an informative and entertaining read. Concise and comprehensive, the book is an accessible guide to both major and lesser-known artists from around the world. Each entry provides a concise description of a particular artist’s life and work, and assesses the nature of their creative insight and cultural impact. An insightful image of the artist accompanies the text, which is also supplemented by a galleries and museums listing of the artist’s most famous works, and an illuminating quotation by the artist or an art critic. Superb reproductions of many of the masterpieces discussed are also featured throughout the book. About the General Editor Steven Farthing is a painter and the Rootstein Hopkins Research Professor in Drawing at the University of Arts, London. He has been teaching fine art since 1977. His paintings are exhibited in galleries throughout the world.


Sidney Poitier

Sidney Poitier

Author: Aram Goudsouzian

Publisher: Univ of North Carolina Press

Published: 2004

Total Pages: 508

ISBN-13: 9780807828434

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The life and career of Sidney Poitier are analyzed in this biography of the actor, highlighting his work as the only black leading man during the civil rights era and the honors he has received for his work for racial equality in Hollywood.


Astronomy Online

Astronomy Online

Author: Timothy F. Slater

Publisher: Macmillan

Published: 2002-02-15

Total Pages: 44

ISBN-13: 9780716796695

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This content- and feature-rich Web site is the ideal online component to any introductory astronomy lecture course.


The Annenbergs

The Annenbergs

Author: John E. Cooney

Publisher: Simon & Schuster

Published: 1982

Total Pages: 456

ISBN-13:

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"This is the colorful and dramatic biography of two of America's most controversial entrepreneurs: Moses Louis Annenberg, 'the racing wire king, ' who built his fortune in racketeering, invested it in publishing, and lost much of it in the biggest tax evasion case in United States history; and his son, Walter, launcher of TV Guide and Seventeen magazines and former ambassador to Great Britain."--Jacket.


Topics in Nanoscience - Part II: Quantized Structures, Nanoelectronics, Thin Films

Topics in Nanoscience - Part II: Quantized Structures, Nanoelectronics, Thin Films

Author: Wolfram Schommers

Publisher: Foundations of Natural Sci

Published: 2022-01-31

Total Pages: 250

ISBN-13: 9789811242694

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This introductory compendium teaches engineering students how the most common electronic sensors and actuators work. It distinguishes from other books by including the physical and chemical phenomena used as well as the features and specifications of many sensors and actuators. The useful reference text also contains an introductory chapter that deals with their specifications and classification, a chapter about sensor and actuator networks, and a special topic dealing with the fabrication of sensors and actuators using microelectromechanical systems techniques (sensors and actuators on a chip). A set of exercises and six laboratory projects are highlighted.