Statistics In The Pharmaceutical Industry 3rd Edition

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Statistics In the Pharmaceutical Industry

Author : C. Ralph Buncher
Publisher : CRC Press
ISBN 13 : 142005645X
Total Pages : 497 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Statistics In the Pharmaceutical Industry by : C. Ralph Buncher

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.

Statistics In the Pharmaceutical Industry, 3rd Edition

Author : Charles Ralph Buncher
Publisher : CRC Press
ISBN 13 : 9780824790738
Total Pages : 606 pages
Book Rating : 4.7/5 (97 download)

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Book Synopsis Statistics In the Pharmaceutical Industry, 3rd Edition by : Charles Ralph Buncher

Download or read book Statistics In the Pharmaceutical Industry, 3rd Edition written by Charles Ralph Buncher and published by CRC Press. This book was released on 1993-11-17 with total page 606 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Basic Statistics and Pharmaceutical Statistical Applications, Third Edition

Author : James E. De Muth
Publisher : CRC Press
ISBN 13 : 1466596732
Total Pages : 850 pages
Book Rating : 4.4/5 (665 download)

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Book Synopsis Basic Statistics and Pharmaceutical Statistical Applications, Third Edition by : James E. De Muth

Download or read book Basic Statistics and Pharmaceutical Statistical Applications, Third Edition written by James E. De Muth and published by CRC Press. This book was released on 2014-04-28 with total page 850 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Statistical Issues in Drug Development

Author : Stephen S. Senn
Publisher : John Wiley & Sons
ISBN 13 : 9780470723579
Total Pages : 523 pages
Book Rating : 4.7/5 (235 download)

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Book Synopsis Statistical Issues in Drug Development by : Stephen S. Senn

Download or read book Statistical Issues in Drug Development written by Stephen S. Senn and published by John Wiley & Sons. This book was released on 2008-02-28 with total page 523 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Statistical Issues in Drug Development

Author : Stephen S. Senn
Publisher : John Wiley & Sons
ISBN 13 : 1119238579
Total Pages : 84 pages
Book Rating : 4.1/5 (192 download)

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Book Synopsis Statistical Issues in Drug Development by : Stephen S. Senn

Download or read book Statistical Issues in Drug Development written by Stephen S. Senn and published by John Wiley & Sons. This book was released on 2021-08-23 with total page 84 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Filtration and Purification in the Biopharmaceutical Industry, Third Edition

Author : Maik W. Jornitz
Publisher : CRC Press
ISBN 13 : 1351675699
Total Pages : 673 pages
Book Rating : 4.3/5 (516 download)

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Book Synopsis Filtration and Purification in the Biopharmaceutical Industry, Third Edition by : Maik W. Jornitz

Download or read book Filtration and Purification in the Biopharmaceutical Industry, Third Edition written by Maik W. Jornitz and published by CRC Press. This book was released on 2019-06-26 with total page 673 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since sterile filtration and purification steps are becoming more prevalent and critical within medicinal drug manufacturing, the third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of bioprocessing including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. The book is an essential, comprehensive source for all involved in filtration and purification practices, training and compliance. It describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration. Features: Addresses recent biotechnology-related processes and advanced technologies such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration of medium, buffer and end product Presents detailed updates on the latest FDA and EMA regulatory requirements involving filtration and purification practices, as well as discussions on best practises in filter integrity testing Describes current industry quality standards and validation requirements and provides guidance for compliance, not just from an end-user perspective, but also supplier requirement It discusses the advantages of single-use process technologies and the qualification needs Sterilizing grade filtration qualification and process validation is presented in detail to gain the understanding of the regulatory needs The book has been compilated by highly experienced contributors in the field of pharmaceutical and biopharmaceutical processing. Each specific topic has been thoroughly examined by a subject matter expert.

Applied Statistics in the Pharmaceutical Industry

Author : Steven P. Millard
Publisher : Springer Science & Business Media
ISBN 13 : 1475734662
Total Pages : 518 pages
Book Rating : 4.4/5 (757 download)

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Book Synopsis Applied Statistics in the Pharmaceutical Industry by : Steven P. Millard

Download or read book Applied Statistics in the Pharmaceutical Industry written by Steven P. Millard and published by Springer Science & Business Media. This book was released on 2013-11-09 with total page 518 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Pharmaceutical Statistics

Author : Sanford Bolton
Publisher : CRC Press
ISBN 13 : 1420074237
Total Pages : 666 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Pharmaceutical Statistics by : Sanford Bolton

Download or read book Pharmaceutical Statistics written by Sanford Bolton and published by CRC Press. This book was released on 2009-12-23 with total page 666 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Pharmaceutical Statistics Practical And Clinical Applications, Third Edition

Author : Bolton Sanford
Publisher : CRC Press
ISBN 13 :
Total Pages : 776 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Pharmaceutical Statistics Practical And Clinical Applications, Third Edition by : Bolton Sanford

Download or read book Pharmaceutical Statistics Practical And Clinical Applications, Third Edition written by Bolton Sanford and published by CRC Press. This book was released on 1997-01-17 with total page 776 pages. Available in PDF, EPUB and Kindle. Book excerpt: This edition offers new and expanded information on recent developments in stability data analysis, concepts of statistical outliners, bioequivalence studies, problems in sampling and devising limits for product release, covariance analysis and tolerance intervals, multiple endpoints and clinical data analysis, and more. student price which is available upon request from Marcel Dekker.

Pharmaceutical Statistics

Author : Sanford Bolton
Publisher :
ISBN 13 :
Total Pages : 680 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Pharmaceutical Statistics by : Sanford Bolton

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:

Statistical Analysis of Designed Experiments

Author : Helge Toutenburg
Publisher : Springer Science & Business Media
ISBN 13 : 0387227725
Total Pages : 507 pages
Book Rating : 4.3/5 (872 download)

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Book Synopsis Statistical Analysis of Designed Experiments by : Helge Toutenburg

Download or read book Statistical Analysis of Designed Experiments written by Helge Toutenburg and published by Springer Science & Business Media. This book was released on 2006-05-09 with total page 507 pages. Available in PDF, EPUB and Kindle. Book excerpt: Unique in commencing with relatively simple statistical concepts and ideas found in most introductory statistical textbooks, this book goes on to cover more material useful for undergraduates and graduate in statistics and biostatistics.

Pharmaceutical Statistics Using SAS

Author : Alex Dmitrienko, Ph.D.
Publisher : SAS Institute
ISBN 13 : 1629590304
Total Pages : 464 pages
Book Rating : 4.6/5 (295 download)

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Book Synopsis Pharmaceutical Statistics Using SAS by : Alex Dmitrienko, Ph.D.

Download or read book Pharmaceutical Statistics Using SAS written by Alex Dmitrienko, Ph.D. and published by SAS Institute. This book was released on 2007-02-07 with total page 464 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Sample Size Calculations in Clinical Research

Author : Shein-Chung Chow
Publisher : CRC Press
ISBN 13 : 1351727117
Total Pages : 954 pages
Book Rating : 4.3/5 (517 download)

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Book Synopsis Sample Size Calculations in Clinical Research by : Shein-Chung Chow

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 2017-08-15 with total page 954 pages. Available in PDF, EPUB and Kindle. Book excerpt: Praise for the Second Edition: "... this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics "This impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehensively, with separate sample size formulae for testing equality, non-inferiority, and equivalence. Many less familiar topics are also covered ..." – Journal of the Royal Statistical Society Sample Size Calculations in Clinical Research, Third Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. A comprehensive and unified presentation of statistical concepts and practical applications, this book includes a well-balanced summary of current and emerging clinical issues, regulatory requirements, and recently developed statistical methodologies for sample size calculation. Features: Compares the relative merits and disadvantages of statistical methods for sample size calculations Explains how the formulae and procedures for sample size calculations can be used in a variety of clinical research and development stages Presents real-world examples from several therapeutic areas, including cardiovascular medicine, the central nervous system, anti-infective medicine, oncology, and women’s health Provides sample size calculations for dose response studies, microarray studies, and Bayesian approaches This new edition is updated throughout, includes many new sections, and five new chapters on emerging topics: two stage seamless adaptive designs, cluster randomized trial design, zero-inflated Poisson distribution, clinical trials with extremely low incidence rates, and clinical trial simulation.

Common Statistical Methods for Clinical Research with SAS Examples, Third Edition

Author : Glenn Walker
Publisher : SAS Institute
ISBN 13 : 1607644258
Total Pages : 553 pages
Book Rating : 4.6/5 (76 download)

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Book Synopsis Common Statistical Methods for Clinical Research with SAS Examples, Third Edition by : Glenn Walker

Download or read book Common Statistical Methods for Clinical Research with SAS Examples, Third Edition written by Glenn Walker and published by SAS Institute. This book was released on 2010-02-15 with total page 553 pages. Available in PDF, EPUB and Kindle. Book excerpt: Glenn Walker and Jack Shostak's Common Statistical Methods for Clinical Research with SAS Examples, Third Edition, is a thoroughly updated edition of the popular introductory statistics book for clinical researchers. This new edition has been extensively updated to include the use of ODS graphics in numerous examples as well as a new emphasis on PROC MIXED. Straightforward and easy to use as either a text or a reference, the book is full of practical examples from clinical research to illustrate both statistical and SAS methodology. Each example is worked out completely, step by step, from the raw data. Common Statistical Methods for Clinical Research with SAS Examples, Third Edition, is an applications book with minimal theory. Each section begins with an overview helpful to nonstatisticians and then drills down into details that will be valuable to statistical analysts and programmers. Further details, as well as bonus information and a guide to further reading, are presented in the extensive appendices. This text is a one-source guide for statisticians that documents the use of the tests used most often in clinical research, with assumptions, details, and some tricks--all in one place. This book is part of the SAS Press program.

Statistical Thinking for Non-Statisticians in Drug Regulation

Author : Richard Kay
Publisher : John Wiley & Sons
ISBN 13 : 1119867401
Total Pages : 436 pages
Book Rating : 4.1/5 (198 download)

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Book Synopsis Statistical Thinking for Non-Statisticians in Drug Regulation by : Richard Kay

Download or read book Statistical Thinking for Non-Statisticians in Drug Regulation written by Richard Kay and published by John Wiley & Sons. This book was released on 2022-11-29 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Pharmaceutical Manufacturing Encyclopedia

Author : Marshall Sittig
Publisher :
ISBN 13 :
Total Pages : 938 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Pharmaceutical Manufacturing Encyclopedia by : Marshall Sittig

Download or read book Pharmaceutical Manufacturing Encyclopedia written by Marshall Sittig and published by . This book was released on 1988 with total page 938 pages. Available in PDF, EPUB and Kindle. Book excerpt: Organized by generic pharmaceutical, describes the manufacturing process. Data includes the therapeutic function, chemical and common names, raw materials contained, the CAS registry, numbers, plus a world-wide list of trade names and manufacturers.

Medical Statistics at a Glance

Author : Aviva Petrie
Publisher : Wiley-Blackwell
ISBN 13 : 9780632050758
Total Pages : 144 pages
Book Rating : 4.0/5 (57 download)

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Book Synopsis Medical Statistics at a Glance by : Aviva Petrie

Download or read book Medical Statistics at a Glance written by Aviva Petrie and published by Wiley-Blackwell. This book was released on 2000-08-16 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt: In line with the other books in the at a Glance series, Medical Statistics at a Glance leads the reader through a number of self-contained topics, each covering a different aspect of medical statistics. The majority of these use the standard 'At a Glance' format of two pages per topic. The authors have provided a basic introduction to the underlying concepts of medical statistics and a guide to the most commonly used statistical procedures. Topics describing a statistical technique are accompanied by a worked example, using real data, illustrating its use. Where possible, the same data set has been used in more than one topic to reflect the reality of data analysis. Detailed and complex hand calculations have been avoided with a concentration on the interpretation of computer data analysis. Medical Statistics at a Glance is versatile in its use as an explanation, a revision summary and a long-term source of reference. Worked examples to accompany each topic. Emphasis on computer analysis of data rather than hand calculations. Supported by a website at http://www.medstatsaag.com/ - this site contains useful self-assessment questions to aid student learning.