Drug safety assessment in clinical trials /

Bibliographic Details
Other Authors: Sogliero-Gilbert, Gene, 1925-
Format: Book
Language:English
Published: New York : Dekker, [1993]
Series:Statistics, textbooks and monographs ; v. 138.
Subjects:

MARC

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264 1 |a New York :  |b Dekker,  |c [1993] 
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300 |a x, 437 pages :  |b illustrations ;  |c 24 cm. 
336 |a text  |2 rdacontent  |b txt 
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490 1 |a Statistics, textbooks and monographs ;  |v v. 138 
504 |a Includes bibliographical references and index. 
505 0 |a Preclinical drug safety evaluation / James T. Mayne -- Adverse drug events in clinical trials / Deborah S. Kirby -- Laboratory testing in clinical trials / Deborah S. Kirby -- Drug Research in the elderly / Piet M. Hooymans and Robert Janknegt -- Drug assessment in critical illness / M.I. Bowden and J.F. Bion -- Laboratory data in multicenter trials: monitoring, adjustment, and summarization / Lawrence K. Oliver and Christy Chuang-Stein -- Genie score: a multivariate assessment of laboratory abnormalities / Gene Sogliero-Gilbert, Lonni Zubkoff-Schulz and Naitee Ting -- Laboratory parameters and drug safety / Norman E. Pitts -- Unified approach to the analysis of safety data in clinical trials / Christy Chuang-Stein and Noel R. Mohberg -- Use of hazard functions in safety analysis / David S. Salsburg -- Meta-analysis of drug safety data / Gary G. Koch ... [et al.] -- Design and analysis considerations for safety data, particularly adverse events / Karl E. Peace -- Clinical trial adverse drug experience reporting requirements in the major countries: one manufacturer's approach / Max W. Talbott and Ellen D. Kelso. 
505 0 |a (cont.) Safety surveillance / Norman E. Pitts -- Postmarketing surveillance: applications and limitations with special reference to the fluoroquinolones / Robert Janknegt and Yechiel A. Hekskter. 
650 2 |a Clinical Trials as Topic  |x methods. 
650 2 |a Drug Evaluation  |x methods. 
700 1 |a Sogliero-Gilbert, Gene,  |d 1925- 
830 0 |a Statistics, textbooks and monographs ;  |v v. 138. 
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