Drug Safety Data ─ How to Analyze, Summarize, and Interpret to Determine Risk
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Klepper and Cobert, pharmacovigilance consultants, provide drug safety professionals, pharmaceutical and clinical research scientists and others in the field, with information on the analysis, summary, and interpretation of drug safety data collected during drug development. They cover exposure, demographics, side effects, vital signs and physical findings, special groups, pregnancy and lactation, overdose, drug abuse, withdrawal, ability to drive, and other factors. They also explain how to identify safety signals and false signals, and determine a drug's effect, clinical significance, and risk profile, including integrated analysis of safety, and the preparation of the Periodic Safety Update Report for a Marketed Drug (with sample reports). Annotation c2011 Book News, Inc., Portland, OR (booknews.com)
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