Drug safety assessment in clinical trials /

Drug safety assessment in clinical trials / edited by Gene Sogliero-Gilbert. - New York : Marcel dekker, Inc., c1993. - x, 437 p. : ill. ; 24 cm. - Statistics, textbooks and monographs. .

Includes bibliographical references and index.

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. (cont.) Safety surveillance / Norman E. Pitts --
Postmarketing surveillance: applications and limitations with special reference to the fluoroquinolones / Robert Janknegt and Yechiel A. Hekskter TOC



0824788931 9780824788933

93008117


Drugs--Testing.
Drugs--Testing--Statistical methods.
Drugs--Toxicology.

RM301.27 / .D79 1993

615.1901 / DRU 1993

QV 771 D7948 1993

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