Drug safety assessment in clinical trials

著者

• Sogliero-Gilbert, Gene

書誌事項

Drug safety assessment in clinical trials

edited by Gene Sogliero-Gilbert

（Statistics : textbooks and monographs, v. 138）

Marcel Dekker, c1993

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 "

「Nielsen BookData」 より

• NII書誌ID(NCID): BA20662147
• ISBN:
  • 0824788931
• LCCN: 93008117
• 出版国コード: us
• タイトル言語コード: eng
• 本文言語コード: eng
• 出版地: New York
• ページ数/冊数: x, 437 p.
• 大きさ: 24 cm
• 分類:
  • LCC : RM301.27
  • NLM : QV 771 D7948 1993
  • DC20 : 615/.1901
• 件名:
  • LCSH : Drugs -- Testing
  • LCSH : Drugs -- Testing -- Statistical methods
  • LCSH : Drugs -- Toxicology
  • MESH : Drug Evaluation -- methods
  • MESH : Clinical Trials -- methods
• 親書誌ID:
  • BA0001061X