Title: Drug safety assessment in clinical trials /
Authors: Sogliero-Gilbert, Gene, 1925-
Publisher: Dekker,
Year: 1993
Subjects: Drugs Testing.; Drugs Testing Statistical methods.; Drugs Toxicology.; Drug Evaluation methods; Clinical Trials as Topic methods
Contents: 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 [and others] -- 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.