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Title Biopharmaceutical Sequential Statistical Applications / editor, Karl E. Peace.
Imprint Boca Raton, FL : CRC Press, 1992.


 Internet  Electronic Book    AVAILABLE
Edition First edition.
Description 1 online resource : text file, PDF
Series Statistics, textbooks and monographs ; v. 128
Statistics, textbooks and monographs ; v. 128.
Bibliog. Includes bibliographical references and index.
Note Available only to authorized UTEP users.
Subject Mathematical statistics.
Clinical trials.
Clinical Trials
Drug Evaluation.
Contents Cover; Half Title; Title Page; Copyright Page; Contents; Preface; Contributors; I: Sequential Methods; 1 Overview of the Development of Sequential Procedures; I. Introduction; II. Development Of Sequential Methods; A. Classical Open and Closed Sequential Designs; B. Response Adaptive and Bayesian Approaches; C. Group Sequential Methods; D. Pseudosequential and Semi-Bayesian Approaches; III. Discussion; References; 2 Practical Approaches to the Design and Conduct of Interim Analyses; I. Introduction; II. Monitoring Versus Interim Analysis; III. Reasons For Interim Analyses
A. Trends in Aggregate Safety DataB. Abandoning Lost Causes; C. Generation of New Hypotheses; D. Resource and Production Decisions; E. Overwhelming Efficacy in Life-Threatening Conditions; IV. Logistical Issues In The Interim Analysis Process; A. Timing and Speed of Analyses; B. Resources; C. Data Retrieval; D. Data Management; V. Interim Analysis Risk Management; VI. Dissemination of the Results of the Analysis; VII. CONCLUSION; References; 3 Group Sequential Designs for Trials with Multiple Endpoints; I. Introduction; II. Methods; A. Bonferroni Correction; B. O'Brien's Statistics
C. Use of O'Brien's Statistics in Group Sequential TrialsIII. Discussion; References; II: Applications In Drug Screening; 4 Statistical Design Considerations for Stagewise, Adaptive Dose Allocation in Dose-Response Studies; I. Introduction; II. Stagewise, Adaptive Design Approach: Theory and Methods; A. Assumptions and Objectives; B. Design Process During the Experiment; C. Design Strategy Prior to the Experiment: Target Designs; D.A Priori Dose-Response Distributions and Past Data; E. Expected Information from the Target Designs; F. Sensitivity Analysis
G. SAS Computer Program to Carry Out the Stagewise, Adaptive Dose Allocation ProceduresIII. Case Study Of The Application Of The Stagewise, Adaptive Dose Allocation Strategy; A. Background; B. Design Strategy Prior to the Experiment; C. Development of the A Priori Distribution; D. Choice of Doses for Stage 1; E. Intermediate Experimental Results: Choice of Doses for Stages 2 and 3; F. Sensitivity Analysis of Alternative Candidate Dose Allocations to Select Doses for Stage 4; IV. Additional Examples Of The Application Ofthe Stagewise, Adaptive Dose Allocation Strategy
A. Studies Where the A Priori Assumptions Were ContradictedB. Studies Where the A Priori Assumptions Were Confirmed; C. Application of the Sensitivity Analysis Procedure for Study Planning; V. Discussion And Areas For Further Extension; Appendix; References; 5 Stagewise, Group Sequential Experimental Designs for Comparisons of Quantal Response Levels Obtained with CandidateTreatment Regimens Versus Those with a Concurrent Control or a Specified Standard; I. Introduction; II. Comparison of a Candidate Therapy Response Rate with a Specified Standard Rate (One-Sample Case)
Summary "Focusing on group sequential procedures, summarizes the sequential statistical methods used in anticancer, antiviral, cardiovascular, and gastrointestinal drug research and screening. The clinical and preclinical applications are mainly presented as case studies, many of which form part of New Drug"--Provided by publisher.
Other Author Peace, Karl E., editor.
Other Title 9781482277128 9780824786281