Drug safety assessment in clinical trials
著者
書誌事項
Drug safety assessment in clinical trials
（Statistics : textbooks and monographs, v. 138）
Marcel Dekker, c1993
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注記
Includes bibliographical references and index
内容説明・目次
内容説明
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.
目次
"Preclinical Drug Safety Evaluation Adverse Drug Events in Clinical Trials Laboratory Testing in Clinical Trials Drug Research in the Elderly Drug Assessment in Critical Illness Laboratory Data in Multicenter Trials: Monitoring, Adjustment, and Summarization The Genie Score: A Multivariate Assessment of Laboratory Abnormalities Laboratory Parameters and Drug Safety A Unified Approach to the Analysis of Safety Data in Clinical Trials The Use of Hazard Functions in Safety Analysis Meta-Analysis of Drug Safety Data Design and Analysis Considerations for Safety Data, Particularly Adverse Events Clinical Trial Adverse Drug Experience Reporting Requirements in the Major Countries: One Manufacturer's Approach Safety Surveillance Postmarketing Surveillance: Applications and Limitations, with Special Reference to the Fluoroquinolones "
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