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Applied statistics in the pharmaceutical industry : with case studies using S-Plus / Steven P. Millard, Andreas Krause, editors.

Contributor(s): Material type: TextTextPublication details: New York : Springer, c2001.Description: xviii, 513 p. : ill. ; 24 cmISBN:
  • 9780387988146
  • 0387988149 (alk. paper)
Subject(s): DDC classification:
  • 615.19
LOC classification:
  • .A665 2001
Online resources:
Contents:
Statistics and the Drug Development Process / Bruce Rodda, Steven P. Millard, and Andreas Krause -- One-Factor Comparative Studies Bill Pikounis -- Analysis of Animal Carcinogenicity Data Hongshik Ahn and Ralph L. Kodell -- Analysis of Toxicokinetic and Pharmacokinetic Data from Animal Studies Wherly P. Hoffman, Michael A. Heathman, James Z. Chou, and Darrel L. Allen -- Analysis of Pharmacokinetic Data Ha Nguyen and Dhammika Amaratunga -- Graphical Presentation of Single Patient Results Juergen Bock -- Graphical Insight and Data Analysis for the 2, 2, 2, Crossover Design Bill Pikounis, Tom Bradstreet, and Steven P. Millard -- Design and Analysis of Phase I Trials in Clinical Oncology Axel Benner, Lutz Elder, and Gernot Hartung -- Patient Compliance and its Impact on Steady State Pharmacokinetics Wenping Wang -- Analysis of Analgesic Trials Ene I. Ette, Peter Lockwood, Raymond Miller, and Jaap Mandema -- Power and Sample Size Calculations Juergen Bock -- Comparing Two Treatments in a Large Phase III Clinical Trial Michaela Jahn -- Analysis of Variance: A Comparison Between SAS and S-PLUS Melvin Olson -- Permutation Tests for Phase III Clinical Trials Vance Berger and Anastasia Ivanova -- Sample Size Reestimation Wenping Wong and Andreas Krause -- Meta-Analysis of Clinical Trials Keith O'Rourke, Beverley Shea, and George A. Wells -- Analysis of Health Economic Data John R. Cook, George W. Carides, and Erik J. Dasbach -- Evaluation of the Decimal Reduction Time of a Sterilization Process in Parmaceutical Production Jeffrey Eisele, Mauro Gasparini, and Amy Racine -- Acceptance Sampling Plans by Attributes Harry Yang and David Carlin
Summary: The volume comprises contributions from more than 20 statisticians working in the pharmaceutical industry. The drug development process is described from the viewpoint of statistical applications. The authors describe studies, data, methods, and results that finally lead to a new drug. The focus is on illustrating the practical problems and the statistical approaches to tackle them. Real-world studies form the basis for applying the methods.
Holdings
Item type Current library Call number Copy number Status Date due Barcode
General Lending Carlow Campus Library General Lending 615.19 (Browse shelf(Opens below)) 1 Available 40863

Includes bibliographical references and index.

Statistics and the Drug Development Process / Bruce Rodda, Steven P. Millard, and Andreas Krause -- One-Factor Comparative Studies Bill Pikounis -- Analysis of Animal Carcinogenicity Data Hongshik Ahn and Ralph L. Kodell -- Analysis of Toxicokinetic and Pharmacokinetic Data from Animal Studies Wherly P. Hoffman, Michael A. Heathman, James Z. Chou, and Darrel L. Allen -- Analysis of Pharmacokinetic Data Ha Nguyen and Dhammika Amaratunga -- Graphical Presentation of Single Patient Results Juergen Bock -- Graphical Insight and Data Analysis for the 2, 2, 2, Crossover Design Bill Pikounis, Tom Bradstreet, and Steven P. Millard -- Design and Analysis of Phase I Trials in Clinical Oncology Axel Benner, Lutz Elder, and Gernot Hartung -- Patient Compliance and its Impact on Steady State Pharmacokinetics Wenping Wang -- Analysis of Analgesic Trials Ene I. Ette, Peter Lockwood, Raymond Miller, and Jaap Mandema -- Power and Sample Size Calculations Juergen Bock -- Comparing Two Treatments in a Large Phase III Clinical Trial Michaela Jahn -- Analysis of Variance: A Comparison Between SAS and S-PLUS Melvin Olson -- Permutation Tests for Phase III Clinical Trials Vance Berger and Anastasia Ivanova -- Sample Size Reestimation Wenping Wong and Andreas Krause -- Meta-Analysis of Clinical Trials Keith O'Rourke, Beverley Shea, and George A. Wells -- Analysis of Health Economic Data John R. Cook, George W. Carides, and Erik J. Dasbach -- Evaluation of the Decimal Reduction Time of a Sterilization Process in Parmaceutical Production Jeffrey Eisele, Mauro Gasparini, and Amy Racine -- Acceptance Sampling Plans by Attributes Harry Yang and David Carlin

The volume comprises contributions from more than 20 statisticians working in the pharmaceutical industry. The drug development process is described from the viewpoint of statistical applications. The authors describe studies, data, methods, and results that finally lead to a new drug. The focus is on illustrating the practical problems and the statistical approaches to tackle them. Real-world studies form the basis for applying the methods.

66.10

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