Applied Statistics In The Pharmaceutical Industry


Applied Statistics In The Pharmaceutical Industry
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Applied Statistics In The Pharmaceutical Industry


Applied Statistics In The Pharmaceutical Industry
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Author : Steven P. Millard
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-11-09

Applied Statistics In The Pharmaceutical Industry written by Steven P. Millard and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-11-09 with Medical categories.


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.



Applied Statistics In The Pharmaceutical Industry


Applied Statistics In The Pharmaceutical Industry
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Author : Steven P. Millard
language : en
Publisher:
Release Date : 2014-09-01

Applied Statistics In The Pharmaceutical Industry written by Steven P. Millard and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-09-01 with categories.




Applied Statistics In The Pharmaceutical Industry With Case Studies Using S Plus


Applied Statistics In The Pharmaceutical Industry With Case Studies Using S Plus
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Author : Steven P. Millard
language : en
Publisher:
Release Date : 2010

Applied Statistics In The Pharmaceutical Industry With Case Studies Using S Plus written by Steven P. Millard and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with categories.




Statistics In The Pharmaceutical Industry 3rd Edition


Statistics In The Pharmaceutical Industry 3rd Edition
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Author : Charles Ralph Buncher
language : en
Publisher: CRC Press
Release Date : 1993-11-17

Statistics In The Pharmaceutical Industry 3rd Edition written by Charles Ralph Buncher and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1993-11-17 with Mathematics categories.


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.



Statistical Applications For Chemistry Manufacturing And Controls Cmc In The Pharmaceutical Industry


Statistical Applications For Chemistry Manufacturing And Controls Cmc In The Pharmaceutical Industry
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Author : Richard K. Burdick
language : en
Publisher: Springer
Release Date : 2017-02-14

Statistical Applications For Chemistry Manufacturing And Controls Cmc In The Pharmaceutical Industry written by Richard K. Burdick and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-02-14 with Medical categories.


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.



Statistical Issues In Drug Development


Statistical Issues In Drug Development
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Author : Stephen S. Senn
language : en
Publisher: John Wiley & Sons
Release Date : 2008-02-28

Statistical Issues In Drug Development written by Stephen S. Senn and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-02-28 with Medical categories.


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.



Statistics In The Pharmaceutical Industry


Statistics In The Pharmaceutical Industry
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Author : C. Ralph Buncher
language : en
Publisher: CRC Press
Release Date : 2019-03-07

Statistics In The Pharmaceutical Industry written by C. Ralph Buncher and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-03-07 with Mathematics categories.


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.



Statistical Methodology In The Pharmaceutical Sciences


Statistical Methodology In The Pharmaceutical Sciences
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Author : D. A. Berry
language : en
Publisher: CRC Press
Release Date : 2016-04-19

Statistical Methodology In The Pharmaceutical Sciences written by D. A. Berry and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Mathematics categories.


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



Pharmaceutical Statistics


Pharmaceutical Statistics
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Author : David S. Jones
language : en
Publisher: Pharmaceutical Press
Release Date : 2002

Pharmaceutical Statistics written by David S. Jones and has been published by Pharmaceutical Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002 with Medical categories.


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.



Nonclinical Statistics For Pharmaceutical And Biotechnology Industries


Nonclinical Statistics For Pharmaceutical And Biotechnology Industries
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Author : Lanju Zhang
language : en
Publisher: Springer
Release Date : 2016-01-13

Nonclinical Statistics For Pharmaceutical And Biotechnology Industries written by Lanju Zhang and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-01-13 with Medical categories.


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.