Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk
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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abnormal Accessed April Accessed March adverse drug reactions adverse events adverse reactions analysis of safety anaphylaxis bilirubin blood pressure Body Mass Index categorical shifts cells clinical study clinical trials clinically significant changes Conference on Harmonisation controlled Phase 2/3 COX group creatinine criteria decreased determine discontinuation disease dose drug effect drug’s Electrocardiogram Evaluation exposure found in Appendix Harmonisation of Technical heart rate hypertension included increased investigational drug laboratory liver liver function tests mean changes MedDRA Mepro Mepro 5 mg Mepro group myocardial myocardial infarction nonclinical nonclinical studies normal baseline NSAIDs overdose patients Periodic Safety Update Pharmaceuticals for Human Pharmacovigilance Phase 1 studies Phase 2/3 studies placebo postmarketing posttreatment pregnancy PSUR PUBs received Mepro Registration of Pharmaceuticals renal Requirements for Registration risk safety findings Safety Update Report study medication Summary syndrome treatment groups treatment value vital signs