Download or read book Biopharmaceutical Sequential Statistical Applications written by Karl E. Peace and published by CRC Press. This book was released on 1992-03-25 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Biopharmaceutical Sequential Statistical Applications written by Karl E. Peace and published by CRC Press. This book was released on 1992-03-25 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Statistics In the Pharmaceutical Industry written by C. Ralph Buncher and published by CRC Press. This book was released on 2019-03-07 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 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.

Download or read book Pharmaceutical Statistics written by Sanford Bolton and published by . This book was released on 1990 with total page 680 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Group Sequential Methods with Applications to Clinical Trials written by Christopher Jennison and published by CRC Press. This book was released on 1999-09-15 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: Group 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.

Download or read book Applied Sequential Methodologies written by Nitis Mukhopadhyay and published by CRC Press. This book was released on 2004-01-28 with total page 498 pages. Available in PDF, EPUB and Kindle. Book excerpt: A 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.

Download or read book Encyclopedia of Biopharmaceutical Statistics Four Volume Set written by Shein-Chung Chow and published by CRC Press. This book was released on 2018-09-03 with total page 2434 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since 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.

Download or read book Sample Size Calculations in Clinical Research written by Shein-Chung Chow and published by CRC Press. This book was released on 2003-03-04 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sample 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.

Download or read book Asymptotics Nonparametrics and Time Series written by Subir Ghosh and published by CRC Press. This book was released on 1999-02-18 with total page 864 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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."

Download or read book Bayesian Biostatistics written by Donald A. Berry and published by CRC Press. This book was released on 2018-10-03 with total page 702 pages. Available in PDF, EPUB and Kindle. Book excerpt: This 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.

Download or read book Response Surfaces Designs and Analyses written by Andre I. Khuri and published by Routledge. This book was released on 2018-12-18 with total page 533 pages. Available in PDF, EPUB and Kindle. Book excerpt: Response Surfaces: Designs and Analyses; Second Edition presents techniques for designing experiments that yield adequate and reliable measurements of one or several responses of interest, fitting and testing the suitability of empirical models used for acquiring information from the experiments, and for utilizing the experimental results to make decisions concerning the system under investigation. This edition contains chapters on response surface models with block effects and on Taguchi's robust parameter design, additional details on transformation of response variable, more material on modified ridge analysis, and new design criteria, including rotatability for multiresponse experiments. It also presents an innovative technique for displaying correlation among several response. Numerical examples throughout the book plus exercises--with worked solutions to selected problems--complement the text.

Download or read book Handbook of the Normal Distribution Second Edition written by Jagdish K. Patel and published by CRC Press. This book was released on 1996-01-16 with total page 452 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Traces the historical development of the normal law. Second Edition offers a comprehensive treatment of the bivariate normal distribution--presenting entirely new material on normal integrals, asymptotic normality, the asymptotic properties of order statistics, and point estimation and statistical intervals."

Download or read book Linear and Nonlinear Models for the Analysis of Repeated Measurements written by Edward Vonesh and published by CRC Press. This book was released on 1996-11-01 with total page 590 pages. Available in PDF, EPUB and Kindle. Book excerpt: Integrates the latest theory, methodology and applications related to the design and analysis of repeated measurement. The text covers a broad range of topics, including the analysis of repeated measures design, general crossover designs, and linear and nonlinear regression models. It also contains a 3.5 IBM compatible disk, with software to implement immediately the techniques.

Download or read book Nonparametric Regression and Spline Smoothing written by Randall L. Eubank and published by CRC Press. This book was released on 1999-02-09 with total page 359 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides a unified account of the most popular approaches to nonparametric regression smoothing. This edition contains discussions of boundary corrections for trigonometric series estimators; detailed asymptotics for polynomial regression; testing goodness-of-fit; estimation in partially linear models; practical aspects, problems and methods for co

Download or read book Bioequivalence and Statistics in Clinical Pharmacology written by Scott D. Patterson and published by CRC Press. This book was released on 2017-03-27 with total page 434 pages. Available in PDF, EPUB and Kindle. Book excerpt: Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day clinical pharmacology work. The book is a starting point for those involved in such research and covers the methods needed to design, analyze, and interpret bioequivalence trials; explores when, how, and why these studies are performed as part of drug development; and demonstrates the methods using real world examples. Drawing on knowledge gained directly from working in the pharmaceutical industry, the authors set the stage by describing the general role of statistics. Once the foundation of clinical pharmacology drug development, regulatory applications, and the design and analysis of bioequivalence trials are established, including recent regulatory changes in design and analysis and in particular sample-size adaptation, they move on to related topics in clinical pharmacology involving the use of cross-over designs. These include, but are not limited to, safety studies in Phase I, dose-response trials, drug interaction trials, food-effect and combination trials, QTc and other pharmacodynamic equivalence trials, proof-of-concept trials, dose-proportionality trials, and vaccines trials. This second edition addresses several recent developments in the field, including new chapters on adaptive bioequivalence studies, scaled average bioequivalence testing, and vaccine trials. Purposefully designed to be instantly applicable, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition provides examples of SAS and R code so that the analyses described can be immediately implemented. The authors have made extensive use of the proc mixed procedures available in SAS.

Download or read book Statistics for the 21st Century written by Gabor Szekely and published by CRC Press. This book was released on 2000-01-25 with total page 504 pages. Available in PDF, EPUB and Kindle. Book excerpt: A selection of articles presented at the Eighth Lukacs Symposium held at the Bowling Green State University, Ohio. They discuss consistency and accuracy of the sequential bootstrap, hypothesis testing, geometry in multivariate analysis, the classical extreme value model, the analysis of cross-classified data, diffusion models for neural activity, estimation with quadratic loss, econometrics, higher order asymptotics, pre- and post-limit theorems, and more.

Download or read book Elementary Statistical Quality Control written by John T. Burr and published by CRC Press. This book was released on 2004-12-28 with total page 480 pages. Available in PDF, EPUB and Kindle. Book excerpt: Maintaining the reader-friendly features of its popular predecessor, the Second Edition illustrates fundamental principles and practices in statistical quality control for improved quality, reliability, and productivity in the management of production processes and industrial and business operations. Presenting key concepts of statistical quality c