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

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

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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 postmarketing 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, stepbystep 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:* Stepbystep instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reports* Pragmatic tipsand 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 userfriendly 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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We ship your order within 2–3 business days for USA deliveries and 5–8 business days for international shipments. Once your package has been dispatched from our warehouse, you'll receive an email confirmation with a tracking number, allowing you to track the status of your delivery.

Returns
To facilitate a smooth return process, a Return Authorization (RA) Number is required for all returns. Returns without a valid RA number will be declined and may incur additional fees. You can request an RA number within 15 days of the original delivery date. For more details, please refer to our Return & Refund Policy page.

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Warranty

We provide a 2-year limited warranty, from the date of purchase for all our products.

If you believe you have received a defective product, or are experiencing any problems with your product, please contact us.

This warranty strictly does not cover damages that arose from negligence, misuse, wear and tear, or not in accordance with product instructions (dropping the product, etc.).

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