Drug safety assessment in clinical trials / edited by Gene Sogliero-Gilbert.

Contributor(s): Sogliero-Gilbert, Gene, 1925-
Material type: TextTextLanguage: English Series: Statistics, textbooks and monographsPublisher: New York : Marcel dekker, Inc., c1993Description: x, 437 p. : ill. ; 24 cmISBN: 0824788931; 9780824788933Subject(s): Drugs -- Testing | Drugs -- Testing -- Statistical methods | Drugs -- ToxicologyDDC classification: 615.1901 LOC classification: RM301.27 | .D79 1993Online resources: WorldCat details
Contents:
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
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Item type Current location Collection Call number Copy number Status Date due Barcode Item holds
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Non-fiction 615.1901 DRU 1993 (Browse shelf) C-1 Not For Loan 14574
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Includes bibliographical references and index.

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

Pharmacy

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