Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk: How to Analyze, Summarize and Interpret to Determine Risk
Language: English
Published by Jones and Bartlett Publishers, Inc, 2010
- Softcover
- Used
Seller: World of Books Inc, Montgomery, IL, U.S.A.World of Books Inc
AbeBooks seller since March 23, 2026
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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).…
Seller Inventory # CIN0763769126G
- Title
- Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk: How to Analyze, Summarize and Interpret to Determine Risk
- Author
- Michael J Klepper
- Publisher
- Jones and Bartlett Publishers, Inc
- Publication year
- 2010
- Condition
- Good
- Binding
- Paperback
- Language
- English
- ISBN 10
- 0763769126
- ISBN 13
- 9780763769123
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About the Author
Barton Lewis Cobert MD, FACP, FACG, FFPM has had a long career in the clinical practice of' Gastroenterology and Internal Medicine as well as, in the pharmaceutical industry specializing in drug safety and risk management. For over a decade he was Global Head of Drug Safety (side effects) for the Schering-Plough Research Institute and held similar positions for Novartis Consumer Health Inc. He has also worked in the information technology industry at Medidata Solutions. Dr. Cobert was born in New York City and received his BA from New York University and his MD from New York University School of Medicine. He is board certified in Internal Medicine and Gastroenterology.'' He is a fellow of the American College of Physicians, the American College of Gastroenterology and the Faculty of Pharmaceutical Medicine (UK). He has written and lectured extensively both nationally and internationally on drug safety, side effects and the safe use of medications. He has written three books on drug safety including the Manual of Drug Safety and Pharmacovigilance which is used as a textbook in courses on drug safety.' Dr. Cobert is president of BLCMD Associated LLC, a drug safety and pharmacovigilance consulting company in Westfield, NJ.
"About the title" may belong to another edition of this title.
World of Books Inc
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