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Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk: How to Analyze, Summarize and Interpret to Determine Risk - Paperback
$181.71
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by Michael J. Klepper (Author), Barton Cobert (Author)
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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Standard U.S. returns are accepted for eligible new, unopened items within 30 days of carrier delivery. Returns are by mail. Customers are responsible for standard return shipping, there is no restocking fee, and standard exchanges are not offered. Once an approved return is received and inspected, the refund is issued to the original payment method within 5 business days. Damaged, defective, or incorrect items are handled at no return-shipping cost to the customer.
Return eligibility is subject to the full policy. Opened, read, or unsealed books with broken seals or visible wear are final sale. Digital downloads, gift cards, and personalized products are non-refundable. Original shipping charges are not refunded for standard returns. Contact us within 7 days of delivery about damaged, defective, or incorrect items.
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