Statistical Issues in Drug Development
Statistical Issues in Drug Development

Author: Stephen S. Senn

Publisher: John Wiley & Sons

Published: 2008-02-28

Total Pages: 523

ISBN-13: 9780470723579

DOWNLOAD EBOOK

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.

Controversial Statistical Issues in Clinical Trials
Controversial Statistical Issues in Clinical Trials

Author: Shein-Chung Chow

Publisher: CRC Press

Published: 2016-04-19

Total Pages: 598

ISBN-13: 1439849625

DOWNLOAD EBOOK

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

Statistical Inference as Severe Testing
Statistical Inference as Severe Testing

Author: Deborah G. Mayo

Publisher: Cambridge University Press

Published: 2018-09-20

Total Pages: 503

ISBN-13: 1108563309

DOWNLOAD EBOOK

Mounting failures of replication in social and biological sciences give a new urgency to critically appraising proposed reforms. This book pulls back the cover on disagreements between experts charged with restoring integrity to science. It denies two pervasive views of the role of probability in inference: to assign degrees of belief, and to control error rates in a long run. If statistical consumers are unaware of assumptions behind rival evidence reforms, they can't scrutinize the consequences that affect them (in personalized medicine, psychology, etc.). The book sets sail with a simple tool: if little has been done to rule out flaws in inferring a claim, then it has not passed a severe test. Many methods advocated by data experts do not stand up to severe scrutiny and are in tension with successful strategies for blocking or accounting for cherry picking and selective reporting. Through a series of excursions and exhibits, the philosophy and history of inductive inference come alive. Philosophical tools are put to work to solve problems about science and pseudoscience, induction and falsification.

Statistics Done Wrong
Statistics Done Wrong

Author: Alex Reinhart

Publisher: No Starch Press

Published: 2015-03-01

Total Pages: 177

ISBN-13: 1593276206

DOWNLOAD EBOOK

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 Issues in Allocating Funds by Formula
Statistical Issues in Allocating Funds by Formula

Author: National Research Council

Publisher: National Academies Press

Published: 2003-02-24

Total Pages: 162

ISBN-13: 0309087104

DOWNLOAD EBOOK

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

Published: 1989-12-11

Total Pages: 390

ISBN-13: 9780824782900

DOWNLOAD EBOOK

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.

All of Statistics
All of Statistics

Author: Larry Wasserman

Publisher: Springer Science & Business Media

Published: 2013-12-11

Total Pages: 446

ISBN-13: 0387217363

DOWNLOAD EBOOK

Taken literally, the title "All of Statistics" is an exaggeration. But in spirit, the title is apt, as the book does cover a much broader range of topics than a typical introductory book on mathematical statistics. This book is for people who want to learn probability and statistics quickly. It is suitable for graduate or advanced undergraduate students in computer science, mathematics, statistics, and related disciplines. The book includes modern topics like non-parametric curve estimation, bootstrapping, and classification, topics that are usually relegated to follow-up courses. The reader is presumed to know calculus and a little linear algebra. No previous knowledge of probability and statistics is required. Statistics, data mining, and machine learning are all concerned with collecting and analysing data.