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Author: Karl E. Peace
Publisher: CRC Press
Published: 1992-03-25
Total Pages: 377
ISBN-13: 1482277123
DOWNLOAD EBOOKFocusing 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
Author: Karl E. Peace
Publisher: CRC Press
Published: 1992-03-25
Total Pages: 382
ISBN-13: 9780824786281
DOWNLOAD EBOOKFocusing 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
Author: C. Ralph Buncher
Publisher: CRC Press
Published: 2019-03-07
Total Pages: 497
ISBN-13: 142005645X
DOWNLOAD EBOOKThe growth of the pharmaceutical industry over the past decade is astounding, but the impact of this growth on statistics is somewhat confusing. While software has made analysis easier and more efficient, regulatory bodies now demand deeper and more complex analyses, and pharmacogenetic/genomic studies serve up an entirely new set of challenges. For more than two decades, Statistics in the Pharmaceutical Industry has been the definitive guide to sorting through the challenges in the industry, and this Third Edition continues that tradition. Updated and expanded to reflect the most recent trends and developments in the field, Statistics in the Pharmaceutical Industry, Third Edition presents chapters written by experts from both regulatory agencies and pharmaceutical companies who discuss everything from experimental design to post-marketing studies. This approach sheds light on what regulators consider acceptable methodologies and what methods have proven successful for industrial statisticians. Both new and revised chapters reflect the increasingly global nature of the industry as represented by authors from Japan and Europe, the increasing trend toward non-inferiority/equivalence testing, adaptive design in clinical trials, global harmonization of regulatory standards, and multiple comparison studies. The book also examines the latest considerations in anti-cancer studies. Statistics in the Pharmaceutical Industry, Third Edition demystifies the approval process by combining regulatory and industrial points of view, making it a must-read for anyone performing statistical analysis at any point in the drug approval process.
Author: Christopher Jennison
Publisher: CRC Press
Published: 1999-09-15
Total Pages: 416
ISBN-13: 9781584888581
DOWNLOAD EBOOKGroup sequential methods answer the needs of clinical trial monitoring committees who must assess the data available at an interim analysis. These interim results may provide grounds for terminating the study-effectively reducing costs-or may benefit the general patient population by allowing early dissemination of its findings. Group sequential methods provide a means to balance the ethical and financial advantages of stopping a study early against the risk of an incorrect conclusion. Group Sequential Methods with Applications to Clinical Trials describes group sequential stopping rules designed to reduce average study length and control Type I and II error probabilities. The authors present one-sided and two-sided tests, introduce several families of group sequential tests, and explain how to choose the most appropriate test and interim analysis schedule. Their topics include placebo-controlled randomized trials, bio-equivalence testing, crossover and longitudinal studies, and linear and generalized linear models. Research in group sequential analysis has progressed rapidly over the past 20 years. Group Sequential Methods with Applications to Clinical Trials surveys and extends current methods for planning and conducting interim analyses. It provides straightforward descriptions of group sequential hypothesis tests in a form suited for direct application to a wide variety of clinical trials. Medical statisticians engaged in any investigations planned with interim analyses will find this book a useful and important tool.
Author: Nitis Mukhopadhyay
Publisher: CRC Press
Published: 2004-01-28
Total Pages: 498
ISBN-13: 9780824753955
DOWNLOAD EBOOKA technically precise yet clear presentation of modern sequential methodologies having immediate applications to practical problems in the real world, Applied Sequential Methodologies communicates invaluable techniques for data mining, agricultural science, genetics, computer simulation, finance, clinical trials, sonar signal detection, randomization, multiple comparisons, psychology, tracking, surveillance, and numerous additional areas of application. Includes more than 500 references, 165 figures and tables, and over 25 pages of subject and author indexes. Applied Sequential Methodologies brings the crucial nature of sequential approaches up to speed with recent theoretical gains, demonstrating their utility for solving real-life problems associated with Change-point detection in multichannel and distributed systems Best component selection for multivariate distributions Multistate processes Approximations for moving sums of discrete random variables Interim and terminal analyses of clinical trials Adaptive designs for longitudinal clinical trials Slope estimation in measurement-error models Tests for randomization and target tracking Appropriate count of simulation runs Stock price models Orders of genes Size and power control in multiple comparisons Authored by 33 leading scientists, this volume will greatly benefit sequential analysts, data analysts, applied statisticians, biometricians, clinical trialists, and upper-level undergraduate and graduate students in these disciplines.
Author: Shein-Chung Chow
Publisher: CRC Press
Published: 2018-09-03
Total Pages: 2434
ISBN-13: 1351110268
DOWNLOAD EBOOKSince the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences. Features of the Fourth Edition: 1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters. 2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies. 3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development. 4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics. About the Editor: Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.
Author: Sanford Bolton
Publisher:
Published: 1990
Total Pages: 680
ISBN-13:
DOWNLOAD EBOOKAuthor: Shein-Chung Chow
Publisher: CRC Press
Published: 2003-03-04
Total Pages: 352
ISBN-13: 0824748239
DOWNLOAD EBOOKSample size calculation plays an important role in clinical research. It is not uncommon, however, to observe discrepancies among study objectives (or hypotheses), study design, statistical analysis (or test statistic), and sample size calculation. Focusing on sample size calculation for studies conducted during the various phases of clinical research and development, Sample Size Calculation in Clinical Research explores the causes of discrepancies and how to avoid them. This volume provides formulas and procedures for determination of sample size required not only for testing equality, but also for testing non-inferiority/superiority, and equivalence (similarity) based on both untransformed (raw) data and log-transformed data under a parallel-group design or a crossover design with equal or unequal ratio of treatment allocations. It contains a comprehensive and unified presentation of statistical procedures for sample size calculation that are commonly employed at various phases of clinical development. Each chapter includes, whenever possible, real examples of clinical studies from therapeutic areas such as cardiovascular, central nervous system, anti-infective, oncology, and women's health to demonstrate the clinical and statistical concepts, interpretations, and their relationships and interactions. The book highlights statistical procedures for sample size calculation and justification that are commonly employed in clinical research and development. It provides clear, illustrated explanations of how the derived formulas and/or statistical procedures can be used.
Author: Subir Ghosh
Publisher: CRC Press
Published: 1999-02-18
Total Pages: 864
ISBN-13: 9780824700515
DOWNLOAD EBOOK"Contains over 2500 equations and exhaustively covers not only nonparametrics but also parametric, semiparametric, frequentist, Bayesian, bootstrap, adaptive, univariate, and multivariate statistical methods, as well as practical uses of Markov chain models."
Author: Donald A. Berry
Publisher: CRC Press
Published: 2018-10-03
Total Pages: 702
ISBN-13: 1482273128
DOWNLOAD EBOOKThis work provides descriptions, explanations and examples of the Bayesian approach to statistics, demonstrating the utility of Bayesian methods for analyzing real-world problems in the health sciences. The work considers the individual components of Bayesian analysis.;College or university bookstores may order five or more copies at a special student price, available on request from Marcel Dekker, Inc.
