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:
Table of 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 ... [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.