Statistics In The Pharmaceutical Industry

Author : C. Ralph Buncher,Jia-Yeong Tsay
Publisher : CRC Press
Page : 497 pages
File Size : 49,5 Mb
Release : 2019-03-07
Category : Mathematics
ISBN : 9781420056457

Get Book

Statistics In the Pharmaceutical Industry by C. Ralph Buncher,Jia-Yeong Tsay Pdf

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.

Author : Charles Ralph Buncher,Jia-Yeong Tsay
Publisher : CRC Press
Page : 606 pages
File Size : 49,7 Mb
Release : 1993-11-17
Category : Mathematics
ISBN : 0824790731

Get Book

Statistics In the Pharmaceutical Industry, 3rd Edition by Charles Ralph Buncher,Jia-Yeong Tsay Pdf

This rewritten and updated second edition provides comprehensive information on the wide-ranging applications of statistics in the pharmacological field. Focusing on practical aspects, it sets out to bridge the gap between industry and academia.;Reflecting the changes that have taken place since publication of the first edition, this volume covers new topics such as: cancer clinical trials, clinical trials of AIDS patients and animal tumorigenicity studies; the development of antiepileptic drugs; the role of epidemiology in postmarketing trials and adverse drug experience; computer-assisted new drug application (CANDA) submissions; contract research organizations; interim analysis in clinical trials; and room-temperature tests for the stability of drugs.;This work is intended as: a reference for statisticians, biostatisticians, pharmacologists, administrators, managers, and scientists in the pharmaceutical industry; and a text for graduate students taking courses in applied statistics or pharmaceutical statistics.

Author : Steven P. Millard,Andreas Krause
Publisher : Springer Science & Business Media
Page : 518 pages
File Size : 51,5 Mb
Release : 2013-11-09
Category : Medical
ISBN : 9781475734669

Get Book

Applied Statistics in the Pharmaceutical Industry by Steven P. Millard,Andreas Krause Pdf

Providing a general guide to statistical methods used in the pharmaceutical industry, and illustrating how to use S-PLUS to implement these methods, the book explains why S-PLUS is a useful software package and discusses the results and implications of each particular application. It is targeted at graduates in biostatistics, statisticians involved in the industry as research scientists, regulators, academics, and/or consultants who want to know more about how to use S-PLUS and learn about other sub-fields within the industry, as well as statisticians in other fields who want to know more about statistical applications in the pharmaceutical industry.

Author : David S. Jones
Publisher : Pharmaceutical Press
Page : 612 pages
File Size : 48,8 Mb
Release : 2002
Category : Medical
ISBN : 0853694257

Get Book

Pharmaceutical Statistics by David S. Jones Pdf

Pharmaceutical Statistics is a new publication on basic statistics, specifically written for pharmacy students. It contains chapters on basic concepts such as types of data, graphical representation of data, distribution and standard deviation. More advanced, frequently used, statistical techniques such as ANOVA and the chi-squared test are also discussed using pharmaceutical examples. Pharmaceutical Statistics is essential reading for all pharmacy students and will also be of interest to those working in the pharmaceutical industry.

Author : Steven P. Millard,Andreas Krause
Publisher : Unknown
Page : 536 pages
File Size : 42,6 Mb
Release : 2014-09-01
Category : Electronic
ISBN : 1475734670

Get Book

Applied Statistics in the Pharmaceutical Industry by Steven P. Millard,Andreas Krause Pdf

Author : D. A. Berry
Publisher : CRC Press
Page : 592 pages
File Size : 45,9 Mb
Release : 2016-04-19
Category : Mathematics
ISBN : 9781482276862

Get Book

Statistical Methodology in the Pharmaceutical Sciences by D. A. Berry Pdf

A state-of-the-art handbook of statistical analysis for use in the pharmaceutical industry. Areas covered in this reference/text include: bioavailability, repeated-measures designs, dose-response, population models, multicenter trials, handling dropouts, survival analysis, robust data analysis, cate

Author : Lanju Zhang
Publisher : Springer
Page : 698 pages
File Size : 52,8 Mb
Release : 2016-01-13
Category : Medical
ISBN : 9783319235585

Get Book

Nonclinical Statistics for Pharmaceutical and Biotechnology Industries by Lanju Zhang Pdf

This book serves as a reference text for regulatory, industry and academic statisticians and also a handy manual for entry level Statisticians. Additionally it aims to stimulate academic interest in the field of Nonclinical Statistics and promote this as an important discipline in its own right. This text brings together for the first time in a single volume a comprehensive survey of methods important to the nonclinical science areas within the pharmaceutical and biotechnology industries. Specifically the Discovery and Translational sciences, the Safety/Toxiology sciences, and the Chemistry, Manufacturing and Controls sciences. Drug discovery and development is a long and costly process. Most decisions in the drug development process are made with incomplete information. The data is rife with uncertainties and hence risky by nature. This is therefore the purview of Statistics. As such, this book aims to introduce readers to important statistical thinking and its application in these nonclinical areas. The chapters provide as appropriate, a scientific background to the topic, relevant regulatory guidance, current statistical practice, and further research directions.

Author : James E. De Muth
Publisher : CRC Press
Page : 850 pages
File Size : 46,6 Mb
Release : 2014-04-28
Category : Mathematics
ISBN : 9781466596733

Get Book

Basic Statistics and Pharmaceutical Statistical Applications, Third Edition by James E. De Muth Pdf

Building on its best-selling predecessors, Basic Statistics and Pharmaceutical Statistical Applications, Third Edition covers statistical topics most relevant to those in the pharmaceutical industry and pharmacy practice. It focuses on the fundamentals required to understand descriptive and inferential statistics for problem solving. Incorporating new material in virtually every chapter, this third edition now provides information on software applications to assist with evaluating data. New to the Third Edition Use of Excel® and Minitab® for performing statistical analysis Discussions of nonprobability sampling procedures, determining if data is normally distributed, evaluation of covariances, and testing for precision equivalence Expanded sections on regression analysis, chi square tests, tests for trends with ordinal data, and tests related to survival statistics Additional nonparametric procedures, including the one-sided sign test, Wilcoxon signed-ranks test, and Mood’s median test With the help of flow charts and tables, the author dispels some of the anxiety associated with using basic statistical tests in the pharmacy profession and helps readers correctly interpret their results using statistical software. Through the text’s worked-out examples, readers better understand how the mathematics works, the logic behind many of the equations, and the tests’ outcomes.

Author : Steven P. Millard
Publisher : Unknown
Page : 128 pages
File Size : 49,8 Mb
Release : 2010
Category : Electronic
ISBN : 8184895054

Get Book

Applied Statistics In The Pharmaceutical Industry: With Case Studies Using S-Plus by Steven P. Millard Pdf

Author : Sanford Bolton,Charles Bon
Publisher : CRC Press
Page : 666 pages
File Size : 51,7 Mb
Release : 2009-12-23
Category : Mathematics
ISBN : 9781420074239

Get Book

Pharmaceutical Statistics by Sanford Bolton,Charles Bon Pdf

Through the use of practical examples and solutions, Pharmaceutical Statistics: Practical and Clinical Applications, Fifth Edition provides the most complete and comprehensive guide to the various statistical applications and research issues in the pharmaceutical industry, particularly in clinical trials and bioequivalence studies.

Author : Richard K. Burdick,David J. LeBlond,Lori B. Pfahler,Jorge Quiroz,Leslie Sidor,Kimberly Vukovinsky,Lanju Zhang
Publisher : Springer
Page : 379 pages
File Size : 46,6 Mb
Release : 2017-02-14
Category : Medical
ISBN : 9783319501864

Get Book

Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry by Richard K. Burdick,David J. LeBlond,Lori B. Pfahler,Jorge Quiroz,Leslie Sidor,Kimberly Vukovinsky,Lanju Zhang Pdf

This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods. The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R will provide more value to the reader. The motivation for this book came from an American Association of Pharmaceutical Scientists (AAPS) short course on statistical methods applied to CMC applications presented by four of the authors. One of the course participants asked us for a good reference book, and the only book recommended was written over 20 years ago by Chow and Liu (1995). We agreed that a more recent book would serve a need in our industry. Since we began this project, an edited book has been published on the same topic by Zhang (2016). The chapters in Zhang discuss statistical methods for CMC as well as drug discovery and nonclinical development. We believe our book complements Zhang by providing more detailed statistical analyses and examples.

Author : Alex Dmitrienko, Ph.D.,Christy Chuang-Stein, Ph.D.,Ralph B. D'Agostino,Sr., Ph.D.
Publisher : SAS Institute
Page : 464 pages
File Size : 41,9 Mb
Release : 2007-02-07
Category : Computers
ISBN : 9781629590301

Get Book

Pharmaceutical Statistics Using SAS by Alex Dmitrienko, Ph.D.,Christy Chuang-Stein, Ph.D.,Ralph B. D'Agostino,Sr., Ph.D. Pdf

Introduces a range of data analysis problems encountered in drug development and illustrates them using case studies from actual pre-clinical experiments and clinical studies. Includes a discussion of methodological issues, practical advice from subject matter experts, and review of relevant regulatory guidelines.

Author : Stephen S. Senn
Publisher : John Wiley & Sons
Page : 523 pages
File Size : 55,6 Mb
Release : 2008-02-28
Category : Medical
ISBN : 0470723572

Get Book

Statistical Issues in Drug Development by Stephen S. Senn Pdf

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.

Author : Richard Kay
Publisher : John Wiley & Sons
Page : 436 pages
File Size : 48,8 Mb
Release : 2022-11-29
Category : Medical
ISBN : 9781119867401

Get Book

Statistical Thinking for Non-Statisticians in Drug Regulation by Richard Kay Pdf

STATISTICAL THINKING FOR NON-STATISTICIANS IN DRUG REGULATION Statistical methods in the pharmaceutical industry are accepted as a key element in the design and analysis of clinical studies. Increasingly, the medical and scientific community are aligning with the regulatory authorities and recognizing that correct statistical methodology is essential as the basis for valid conclusions. In order for those correct and robust methods to be successfully employed there needs to be effective communication across disciplines at all stages of the planning, conducting, analyzing and reporting of clinical studies associated with the development and evaluation of new drugs and devices. Statistical Thinking for Non-Statisticians in Drug Regulation provides a comprehensive in-depth guide to statistical methodology for pharmaceutical industry professionals, including physicians, investigators, medical science liaisons, clinical research scientists, medical writers, regulatory personnel, statistical programmers, senior data managers and those working in pharmacovigilance. The author’s years of experience and up-to-date familiarity with pharmaceutical regulations and statistical practice within the wider clinical community make this an essential guide for the those working in and with the industry. The third edition of Statistical Thinking for Non-Statisticians in Drug Regulation includes: A detailed new chapter on Estimands in line with the 2019 Addendum to ICH E9 Major new sections on topics including Combining Hierarchical Testing and Alpha Adjustment, Biosimilars, Restricted Mean Survival Time, Composite Endpoints and Cumulative Incidence Functions, Adjusting for Cross-Over in Oncology, Inverse Propensity Score Weighting, and Network Meta-Analysis Updated coverage of many existing topics to reflect new and revised guidance from regulatory authorities and author experience Statistical Thinking for Non-Statisticians in Drug Regulation is a valuable guide for pharmaceutical and medical device industry professionals, as well as statisticians joining the pharmaceutical industry and students and teachers of drug development.

Author : Todd A. Durham,J. Rick Turner
Publisher : Unknown
Page : 226 pages
File Size : 46,7 Mb
Release : 2008-01-01
Category : Mathematics
ISBN : 0853697140

Get Book

Introduction to Statistics in Pharmaceutical Clinical Trials by Todd A. Durham,J. Rick Turner Pdf

All students of pharmaceutical sciences and clinical research need a solid knowledge and understanding of the nature, methods, application, and importance of statistics. Introduction to Statistics in Pharmaceutical Clinical Trials is an ideal introduction to statistics presented in the context of clinical trials conducted during pharmaceutical drug development. This novel approach both teaches the computational steps needed to conduct analyses and provides a conceptual understanding of how these analyses provide information that forms the rational basis for decision making throughout the drug development process.