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Statistical Issues in Drug Development

Statistical Issues in Drug Development
Author: Stephen S. Senn
Publisher: John Wiley & Sons
Total Pages: 523
Release: 2008-02-28
Genre: Medical
ISBN: 9780470723579

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Drug development is the process of finding and producingtherapeutically useful pharmaceuticals, turning them into safe andeffective medicine, and producing reliable information regardingthe appropriate dosage and dosing intervals. With regulatoryauthorities demanding increasingly higher standards in suchdevelopments, statistics has become an intrinsic and criticalelement in the design and conduct of drug development programmes. Statistical Issues in Drug Development presents anessential and thought provoking guide to the statistical issues andcontroversies involved in drug development. This highly readable second edition has been updated toinclude: Comprehensive coverage of the design and interpretation ofclinical trials. Expanded sections on missing data, equivalence, meta-analysisand dose finding. An examination of both Bayesian and frequentist methods. A new chapter on pharmacogenomics and expanded coverage ofpharmaco-epidemiology and pharmaco-economics. Coverage of the ICH guidelines, in particular ICH E9,Statistical Principles for Clinical Trials. It is hoped that the book will stimulate dialogue betweenstatisticians and life scientists working within the pharmaceuticalindustry. The accessible and wide-ranging coverage make itessential reading for both statisticians and non-statisticiansworking in the pharmaceutical industry, regulatory bodies andmedical research institutes. There is also much to benefitundergraduate and postgraduate students whose courses include amedical statistics component.


Numerical Issues in Statistical Computing for the Social Scientist

Numerical Issues in Statistical Computing for the Social Scientist
Author: Micah Altman
Publisher: John Wiley & Sons
Total Pages: 349
Release: 2004-02-15
Genre: Mathematics
ISBN: 0471475742

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At last—a social scientist's guide through the pitfalls of modern statistical computing Addressing the current deficiency in the literature on statistical methods as they apply to the social and behavioral sciences, Numerical Issues in Statistical Computing for the Social Scientist seeks to provide readers with a unique practical guidebook to the numerical methods underlying computerized statistical calculations specific to these fields. The authors demonstrate that knowledge of these numerical methods and how they are used in statistical packages is essential for making accurate inferences. With the aid of key contributors from both the social and behavioral sciences, the authors have assembled a rich set of interrelated chapters designed to guide empirical social scientists through the potential minefield of modern statistical computing. Uniquely accessible and abounding in modern-day tools, tricks, and advice, the text successfully bridges the gap between the current level of social science methodology and the more sophisticated technical coverage usually associated with the statistical field. Highlights include: A focus on problems occurring in maximum likelihood estimation Integrated examples of statistical computing (using software packages such as the SAS, Gauss, Splus, R, Stata, LIMDEP, SPSS, WinBUGS, and MATLAB®) A guide to choosing accurate statistical packages Discussions of a multitude of computationally intensive statistical approaches such as ecological inference, Markov chain Monte Carlo, and spatial regression analysis Emphasis on specific numerical problems, statistical procedures, and their applications in the field Replications and re-analysis of published social science research, using innovative numerical methods Key numerical estimation issues along with the means of avoiding common pitfalls A related Web site includes test data for use in demonstrating numerical problems, code for applying the original methods described in the book, and an online bibliography of Web resources for the statistical computation Designed as an independent research tool, a professional reference, or a classroom supplement, the book presents a well-thought-out treatment of a complex and multifaceted field.


Controversial Statistical Issues in Clinical Trials

Controversial Statistical Issues in Clinical Trials
Author: Shein-Chung Chow
Publisher: CRC Press
Total Pages: 598
Release: 2016-04-19
Genre: Health & Fitness
ISBN: 1439849625

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In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good clinical practice. But by identifying the causes of the issues and correcting them, the study objectives of clinical trials can be better achieved. Controversial Statistical Issues in Clinical Trials cov


Combining Information

Combining Information
Author:
Publisher: National Academies
Total Pages: 234
Release: 1992-01-01
Genre: Mathematics
ISBN:

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Statistical Issues in Drug Development

Statistical Issues in Drug Development
Author: Stephen S. Senn
Publisher: John Wiley & Sons
Total Pages: 84
Release: 2021-08-23
Genre: Medical
ISBN: 1119238579

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Statistical Issues in Drug Development The revised third edition of Statistical Issues in Drug Development delivers an insightful treatment of the intersection between statistics and the life sciences. The book offers readers new discussions of crucial topics, including cluster randomization, historical controls, responder analysis, studies in children, post-hoc tests, estimands, publication bias, the replication crisis, and many more. This work presents the major statistical issues in drug development in a way that is accessible and comprehensible to life scientists working in the field, and takes pains not to gloss over significant disagreements in the field of statistics, while encouraging communication between the statistical and life sciences disciplines. In addition to new material on topics like invalid inversion, severity, random effects in network meta-analysis, and explained variation, readers will benefit from the inclusion of: A thorough introduction to basic topics in drug development and statistics, including the role played by statistics in drug development An exploration of the four views of statistics in drug development, including the historical, methodological, technical, and professional An examination of debatable and controversial topics in drug development, including the allocation of treatments to patients in clinical trials, baselines and covariate information, and the measurement of treatment effects Perfect for life scientists and other professionals working in the field of drug development, Statistical Issues in Drug Development is the ideal resource for anyone seeking a one-stop reference to enhance their understanding of the use of statistics during drug development.


Statistical Science in the Courtroom

Statistical Science in the Courtroom
Author: Joseph L. Gastwirth
Publisher: Springer Science & Business Media
Total Pages: 454
Release: 2012-12-06
Genre: Social Science
ISBN: 1461212162

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Expert testimony relying on scientific and other specialized evidence has come under increased scrutiny by the legal system. A trilogy of recent U.S. Supreme Court cases has assigned judges the task of assessing the relevance and reliability of proposed expert testimony. In conjunction with the Federal judiciary, the American Association for the Advancement of Science has initiated a project to provide judges indicating a need with their own expert. This concern with the proper interpretation of scientific evidence, especially that of a probabilistic nature, has also occurred in England, Australia and in several European countries. Statistical Science in the Courtroom is a collection of articles written by statisticians and legal scholars who have been concerned with problems arising in the use of statistical evidence. A number of articles describe DNA evidence and the difficulties of properly calculating the probability that a random individual's profile would "match" that of the evidence as well as the proper way to intrepret the result. In addition to the technical issues, several authors tell about their experiences in court. A few have become disenchanted with their involvement and describe the events that led them to devote less time to this application. Other articles describe the role of statistical evidence in cases concerning discrimination against minorities, product liability, environmental regulation, the appropriateness and fairness of sentences and how being involved in legal statistics has raised interesting statistical problems requiring further research.


Statistics Done Wrong

Statistics Done Wrong
Author: Alex Reinhart
Publisher: No Starch Press
Total Pages: 177
Release: 2015-03-01
Genre: Mathematics
ISBN: 1593276737

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Scientific progress depends on good research, and good research needs good statistics. But statistical analysis is tricky to get right, even for the best and brightest of us. You'd be surprised how many scientists are doing it wrong. Statistics Done Wrong is a pithy, essential guide to statistical blunders in modern science that will show you how to keep your research blunder-free. You'll examine embarrassing errors and omissions in recent research, learn about the misconceptions and scientific politics that allow these mistakes to happen, and begin your quest to reform the way you and your peers do statistics. You'll find advice on: –Asking the right question, designing the right experiment, choosing the right statistical analysis, and sticking to the plan –How to think about p values, significance, insignificance, confidence intervals, and regression –Choosing the right sample size and avoiding false positives –Reporting your analysis and publishing your data and source code –Procedures to follow, precautions to take, and analytical software that can help Scientists: Read this concise, powerful guide to help you produce statistically sound research. Statisticians: Give this book to everyone you know. The first step toward statistics done right is Statistics Done Wrong.


Statistical Topics and Stochastic Models for Dependent Data with Applications

Statistical Topics and Stochastic Models for Dependent Data with Applications
Author: Vlad Stefan Barbu
Publisher: John Wiley & Sons
Total Pages: 288
Release: 2020-12-03
Genre: Mathematics
ISBN: 1786306034

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This book is a collective volume authored by leading scientists in the field of stochastic modelling, associated statistical topics and corresponding applications. The main classes of stochastic processes for dependent data investigated throughout this book are Markov, semi-Markov, autoregressive and piecewise deterministic Markov models. The material is divided into three parts corresponding to: (i) Markov and semi-Markov processes, (ii) autoregressive processes and (iii) techniques based on divergence measures and entropies. A special attention is payed to applications in reliability, survival analysis and related fields.


Statistical Issues in Allocating Funds by Formula

Statistical Issues in Allocating Funds by Formula
Author: National Research Council
Publisher: National Academies Press
Total Pages: 162
Release: 2003-02-24
Genre: Political Science
ISBN: 0309087104

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In 2000, the federal government distributed over $260 billion of funding to state and local governments via 180 formula programs. These programs promote a wide spectrum of economic and social objectives, such as improving educational outcomes and increasing accessibility to medical care, and many are designed to compensate for differences in fiscal capacity that affect governments' abilities to address identified needs. Large amounts of state revenues are also distributed through formula allocation programs to counties, cities, and other jurisdictions. Statistical Issues in Allocating Funds by Formula identifies key issues concerning the design and use of these formulas and advances recommendations for improving the process. In addition to the more narrow issues relating to formula design and input data, the book discusses broader issues created by the interaction of the political process and the use of formulas to allocate funds. Statistical Issues in Allocating Funds by Formula is only up-to-date guide for policymakers who design fund allocation programs. Congress members who are crafting legislation for these programs and federal employees who are in charge of distributing the funds will find this book indispensable.


Statistical Issues in Drug Research and Development

Statistical Issues in Drug Research and Development
Author: Karl E. Peace
Publisher: CRC Press
Total Pages: 390
Release: 1989-12-11
Genre: Mathematics
ISBN: 9780824782900

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This book is a compilation of topics addressed by the ASA Biopharmaceutical Section work groups, including the etiology and evolution of the work groups, the work group guidelines and structure, and the statistical issues associated with clinical trials in clinical drug development programs.