Design And Analysis Of Animal Studies In Pharmaceutical Development
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Design And Analysis Of Animal Studies In Pharmaceutical Development
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Author : Shein-Chung Chow
language : en
Publisher: CRC Press
Release Date : 1998-01-15
Design And Analysis Of Animal Studies In Pharmaceutical Development 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 1998-01-15 with Mathematics categories.
"Provides well-integrated, comprehensive coverage of all the major statistical designs and methods used for animal studies in pharmaceutical research and development. Demonstrates the correct way to interpret the results of animal studies in the risk assessment of biopharmaceutical products and clarifies detailed presentations with real-world examples. "
The Design And Statistical Analysis Of Animal Experiments
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Author : Simon T. Bate
language : en
Publisher: Cambridge University Press
Release Date : 2014-03-13
The Design And Statistical Analysis Of Animal Experiments written by Simon T. Bate and has been published by Cambridge University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-03-13 with Computers categories.
This book will provide scientists with a better understanding of statistics, improving their decision-making and reducing animal use.
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.
Noninferiority Testing In Clinical Trials
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Author : Tie-Hua Ng
language : en
Publisher: CRC Press
Release Date : 2014-12-01
Noninferiority Testing In Clinical Trials written by Tie-Hua Ng and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-12-01 with Mathematics categories.
Take Your NI Trial to the Next LevelReflecting the vast research on noninferiority (NI) designs from the past 15 years, Noninferiority Testing in Clinical Trials: Issues and Challenges explains how to choose the NI margin as a small fraction of the therapeutic effect of the active control in a clinical trial. Requiring no prior knowledge of NI test
Medical Biostatistics
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Author : Abhaya Indrayan
language : en
Publisher: CRC Press
Release Date : 2008-03-10
Medical Biostatistics written by Abhaya Indrayan and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-03-10 with Mathematics categories.
Emphasizing statistical concepts used in medicine, the interpretation of methods, and applications, Medical Biostatistics, Second Edition shows how biostatistical methods are important tools in managing uncertainties in medicine and the health sciences. With coverage ranging from elementary topics, such as mean and standard deviation, to adv
Patient Reported Outcomes
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Author : Joseph C. Cappelleri
language : en
Publisher: CRC Press
Release Date : 2013-12-20
Patient Reported Outcomes written by Joseph C. Cappelleri and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-12-20 with Mathematics categories.
Advancing the development, validation, and use of patient-reported outcome (PRO) measures, Patient-Reported Outcomes: Measurement, Implementation and Interpretation helps readers develop and enrich their understanding of PRO methodology, particularly from a quantitative perspective. Designed for biopharmaceutical researchers and others in the health sciences community, it provides an up-to-date volume on conceptual and analytical issues of PRO measures. The book discusses key concepts relating to the measurement, implementation, and interpretation of PRO measures. It covers both introductory and advanced psychometric and biostatistical methods for constructing and analyzing PRO measures. The authors include many relevant real-life applications based on their extensive first-hand experiences in the pharmaceutical industry. They implement a wealth of simulated datasets to illustrate concepts and heighten understanding based on practical scenarios. For readers interested in conducting statistical analyses of PRO measures and delving more deeply into the analytic details, most chapters contain SAS code and output that illustrate the methodology. Along with providing numerous references, the book highlights current regulatory guidelines.
Computational Pharmacokinetics
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Author : Anders Kallen
language : en
Publisher: CRC Press
Release Date : 2007-07-19
Computational Pharmacokinetics written by Anders Kallen and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-07-19 with Mathematics categories.
Being that pharmacokinetics (PK) is the study of how the body handles various substances, it is not surprising that PK plays an important role in the early development of new drugs. However, the clinical research community widely believes that mathematics in some way blurs the true meaning of PK. Demonstrating that quite the opposite is true, Computational Pharmacokinetics outlines the fundamental concepts and models of PK from a mathematical perspective based on clinically relevant parameters. After an introductory chapter, the book presents a noncompartmental approach to PK and discusses the numerical analysis of PK data, including a description of an absorption process through numerical deconvolution. The author then builds a simple physiological model to better understand PK volumes and compares this model to other methods. The book also introduces compartmental models, discusses their limitations, and creates a general-purpose type of model. The final chapter looks at the relationship between drug concentration and effect, known as PK/pharmacodynamics (PD) modeling. With both a solid discussion of theory and the use of practical examples, this book will enable readers to thoroughly grasp the computational factors of PK modeling.
Elementary Bayesian Biostatistics
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Author : Lemuel A. Moye
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Elementary Bayesian Biostatistics written by Lemuel A. Moye 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.
Bayesian analyses have made important inroads in modern clinical research due, in part, to the incorporation of the traditional tools of noninformative priors as well as the modern innovations of adaptive randomization and predictive power. Presenting an introductory perspective to modern Bayesian procedures, Elementary Bayesian Biostatistics explo
Modeling To Inform Infectious Disease Control
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Author : Niels G. Becker
language : en
Publisher: CRC Press
Release Date : 2015-04-28
Modeling To Inform Infectious Disease Control written by Niels G. Becker and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-04-28 with Mathematics categories.
Effectively Assess Intervention Options for Controlling Infectious DiseasesOur experiences with the human immunodeficiency virus (HIV), severe acute respiratory syndrome (SARS), and Ebola virus disease (EVD) remind us of the continuing need to be vigilant against the emergence of new infectious diseases. Mathematical modeling is increasingly used i
Methods And Applications Of Statistics In Clinical Trials Volume 1
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Author : Narayanaswamy Balakrishnan
language : en
Publisher: John Wiley & Sons
Release Date : 2014-03-05
Methods And Applications Of Statistics In Clinical Trials Volume 1 written by Narayanaswamy Balakrishnan 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 2014-03-05 with Medical categories.
A complete guide to the key statistical concepts essential for the design and construction of clinical trials As the newest major resource in the field of medical research, Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs presents a timely and authoritative reviewof the central statistical concepts used to build clinical trials that obtain the best results. The referenceunveils modern approaches vital to understanding, creating, and evaluating data obtained throughoutthe various stages of clinical trial design and analysis. Accessible and comprehensive, the first volume in a two-part set includes newly-written articles as well as established literature from the Wiley Encyclopedia of Clinical Trials. Illustrating a variety of statistical concepts and principles such as longitudinal data, missing data, covariates, biased-coin randomization, repeated measurements, and simple randomization, the book also provides in-depth coverage of the various trial designs found within phase I-IV trials. Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs also features: Detailed chapters on the type of trial designs, such as adaptive, crossover, group-randomized, multicenter, non-inferiority, non-randomized, open-labeled, preference, prevention, and superiority trials Over 100 contributions from leading academics, researchers, and practitioners An exploration of ongoing, cutting-edge clinical trials on early cancer and heart disease, mother-to-child human immunodeficiency virus transmission trials, and the AIDS Clinical Trials Group Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs is an excellent reference for researchers, practitioners, and students in the fields of clinicaltrials, pharmaceutics, biostatistics, medical research design, biology, biomedicine, epidemiology,and public health.