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Drug Safety Assessment in Clinical Trials (Statistics:  A Series of Textbooks and Monographs)
 
 
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Drug Safety Assessment in Clinical Trials (Statistics: A Series of Textbooks and Monographs) [Hardcover]

Gilbert (Author)

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Book Description

July 14, 1993 0824788931 978-0824788933 1

Details the methods pharmaceutical companies employ to determine the safety profile of their drugs. Statistical procedures currently used or developed to analyze, display and compare the massive amounts of laboratory data collected from controlled clinical trials are surveyed.


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an outstanding resource.
---Unlisted Drugs
. . .contains much of value to workers in the field of drug testing. . .clearly written, and certainly earns its place on laboratory or clinical bookshelves.
---International Antiviral News

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Inside This Book (learn more)
First Sentence:
The quest for improved medicines has resulted in a tremendous international effort dedicated to the discovery and development of new drug entities. Read the first page
Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
identical safety profiles, spontaneous postmarketing reports, controlled study environment, safety hypotheses, most abnormal value, postmarketing safety surveillance, safety surveillance system, lab parameters, interlab comparisons, clinical project team, postmarketing period, laboratory safety data, organ system support, proficiency testing results, lab test values, liver function parameters, laboratory test battery, intensity grades, lab abnormalities, causality judgment, clinical trial database, primary therapeutic effect, causality attribution, clinical research program, adverse drug events
Key Phrases - Capitalized Phrases (CAPs): (learn more)
United States, New York, United Kingdom, Marcel Dekker, Reg Toxicol Pharmacol, Clin Pharmacol, Function Group Score, Drug Inf, Arch Intern Med, Regulatory Affairs Department, Clin Pharmacokinet, Federal Food, Final Day, Liver Renal, Safety of Medicines, Stat Med, Working Group, Arch Surg, Arch Toxicol, Controlled Clin Trials, Crit Care Med, Lipid Diabetes Metab, National Institutes of Health, Number of Weeks, Professor Inman
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