Statistics In Drug Research


Statistics In Drug Research
DOWNLOAD

Download Statistics In Drug Research PDF/ePub or read online books in Mobi eBooks. Click Download or Read Online button to get Statistics In Drug Research book now. This website allows unlimited access to, at the time of writing, more than 1.5 million titles, including hundreds of thousands of titles in various foreign languages. If the content not found or just blank you must refresh this page





Statistics In Drug Research


Statistics In Drug Research
DOWNLOAD

Author : Shein-Chung Chow
language : en
Publisher: CRC Press
Release Date : 2002-02-20

Statistics In Drug Research written by Shein-Chung Chow and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002-02-20 with Mathematics categories.


Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics applications for each stage of pharmaceutical development to ensure the valid design, analysis, and assessment of drug products under investigation and establish the safety and efficacy of pharmaceutical compounds. Cove



Statistical Issues In Drug Research And Development


Statistical Issues In Drug Research And Development
DOWNLOAD

Author : KarlE. Peace
language : en
Publisher: Routledge
Release Date : 2017-09-19

Statistical Issues In Drug Research And Development written by KarlE. Peace and has been published by Routledge this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-09-19 with Mathematics categories.




Introduction To Statistics In Pharmaceutical Clinical Trials


Introduction To Statistics In Pharmaceutical Clinical Trials
DOWNLOAD

Author : Todd A. Durham
language : en
Publisher:
Release Date : 2008-01-01

Introduction To Statistics In Pharmaceutical Clinical Trials written by Todd A. Durham and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-01-01 with Mathematics categories.


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.



Statistical Methods In Drug Combination Studies


Statistical Methods In Drug Combination Studies
DOWNLOAD

Author : Wei Zhao
language : en
Publisher: CRC Press
Release Date : 2014-12-19

Statistical Methods In Drug Combination Studies written by Wei Zhao and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-12-19 with Mathematics categories.


The growing interest in using combination drugs to treat various complex diseases has spawned the development of many novel statistical methodologies. The theoretical development, coupled with advances in statistical computing, makes it possible to apply these emerging statistical methods in in vitro and in vivo drug combination assessments. Howeve



Interface Between Regulation And Statistics In Drug Development


Interface Between Regulation And Statistics In Drug Development
DOWNLOAD

Author : Demissie Alemayehu
language : en
Publisher: CRC Press
Release Date : 2020-11-11

Interface Between Regulation And Statistics In Drug Development written by Demissie Alemayehu and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-11-11 with Mathematics categories.


With the critical role of statistics in the design, conduct, analysis and reporting of clinical trials or observational studies intended for regulatory purposes, numerous guidelines have been issued by regulatory authorities around the world focusing on statistical issues related to drug development. However, the available literature on this important topic is sporadic, and often not readily accessible to drug developers or regulatory personnel. This book provides a systematic exposition of the interplay between the two disciplines, including emerging themes pertaining to the acceleration of the development of pharmaceutical medicines to serve patients with unmet needs. Features: Regulatory and statistical interactions throughout the drug development continuum The critical role of the statistician in relation to the changing regulatory and healthcare landscapes Statistical issues that commonly arise in the course of drug development and regulatory interactions Trending topics in drug development, with emphasis on current regulatory thinking and the associated challenges and opportunities The book is designed to be accessible to readers with an intermediate knowledge of statistics, and can be a useful resource to statisticians, medical researchers, and regulatory personnel in drug development, as well as graduate students in the health sciences. The authors’ decades of experience in the pharmaceutical industry and academia, and extensive regulatory experience, comes through in the many examples throughout the book.



Statistical Issues In Drug Development


Statistical Issues In Drug Development
DOWNLOAD

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.



Applied Statistics In The Pharmaceutical Industry


Applied Statistics In The Pharmaceutical Industry
DOWNLOAD

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.



Statistical Methodology In The Pharmaceutical Sciences


Statistical Methodology In The Pharmaceutical Sciences
DOWNLOAD

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



Statistical Issues In Drug Development


Statistical Issues In Drug Development
DOWNLOAD

Author : Stephen S. Senn
language : en
Publisher: John Wiley & Sons
Release Date : 2021-05-25

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 2021-05-25 with Medical categories.


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.



Statistics In The Pharmaceutical Industry


Statistics In The Pharmaceutical Industry
DOWNLOAD

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.