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Author: Shein-Chung Chow
Publisher: CRC Press
ISBN: 1482273136
Category : Mathematics
Languages : en
Pages : 581
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Book Description
"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."
Author: Shein-Chung Chow
Publisher: CRC Press
ISBN: 1482273136
Category : Mathematics
Languages : en
Pages : 581
Get Book
Book Description
"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."
Author: Shein-Chung Chow
Publisher: Wiley-Interscience
ISBN:
Category : Mathematics
Languages : en
Pages : 680
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Book Description
A unique, unifying treatment for statistics and science in clinical trials What sets this volume apart from the many books dealing with clinical trials is its integration of statistical and clinical disciplines. Stressing communication between biostatisticians and clinical scientists, this work clearly relates statistical interpretation to clinical issues arising in different stages of pharmaceutical research and development. Plus, the principles presented here are universal enough to be easily adapted in non-biopharmaceutical settings. Design and Analysis of Clinical Trials tackles concepts and methodologies. It not only covers statistical basics such as uncertainty and bias, design considerations such as patient selection, randomization, and the different types of clinical trials but also deals with various methods of data analysis, group sequential procedures for interim analysis, efficacy data evaluation, analysis of safety data, and more. Throughout, the book: * Surveys current and emerging clinical issues and newly developed statistical methods * Presents a critical review of statistical methodologies in various therapeutic areas * Features case studies from actual clinical trials * Minimizes the mathematics involved, making the material widely accessible * Offers each chapter as a self-contained entity * Includes illustrations to highlight the text This monumental reference on all facets of clinical trials is important reading for physicians, clinical and medical researchers, pharmaceutical scientists, clinical programmers, biostatisticians, and anyone involved in this burgeoning area of clinical research. It can also be used as a textbook in graduate-level courses in the field.
Author: Shein-Chung Chow
Publisher: CRC Press
ISBN: 9780824793364
Category : Mathematics
Languages : en
Pages : 0
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Book Description
"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."
Author: Shein-Chung Chow
Publisher: CRC Press
ISBN: 9781584889069
Category : Mathematics
Languages : en
Pages : 352
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Book Description
The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how stability studies play an important role in drug safety and quality assurance, Statistical Design and Analysis of Stability Studies presents the principles and methodologies in the design and analysis of stability studies. After introducing the basic concepts of stability testing, the book focuses on short-term stability studies and reviews several methods for estimating drug expiration dating periods. It then compares some commonly employed study designs and discusses both fixed and random batch statistical analyses. Following a chapter on the statistical methods for stability analysis under a linear mixed effects model, the book examines stability analyses with discrete responses, multiple components, and frozen drug products. In addition, the author provides statistical methods for dissolution testing and explores current issues and recent developments in stability studies. To ensure the safety of consumers, professionals in the field must carry out stability studies to determine the reliability of drug products during their expiration period. This book provides the material necessary for you to perform stability designs and analyses in pharmaceutical research and development.
Author: D. A. Berry
Publisher: CRC Press
ISBN: 1482276860
Category : Mathematics
Languages : en
Pages : 592
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Book Description
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: Paul J. Mitchell
Publisher: John Wiley & Sons
ISBN: 1119437660
Category : Medical
Languages : en
Pages : 260
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Book Description
Experimental Design and Statistical Analysis for Pharmacology and the Biomedical Sciences A practical guide to the use of basic principles of experimental design and statistical analysis in pharmacology Experimental Design and Statistical Analysis for Pharmacology and the Biomedical Sciences provides clear instructions on applying statistical analysis techniques to pharmacological data. Written by an experimental pharmacologist with decades of experience teaching statistics and designing preclinical experiments, this reader-friendly volume explains the variety of statistical tests that researchers require to analyze data and draw correct conclusions. Detailed, yet accessible, chapters explain how to determine the appropriate statistical tool for a particular type of data, run the statistical test, and analyze and interpret the results. By first introducing basic principles of experimental design and statistical analysis, the author then guides readers through descriptive and inferential statistics, analysis of variance, correlation and regression analysis, general linear modelling, and more. Lastly, throughout the textbook are numerous examples from molecular, cellular, in vitro, and in vivo pharmacology which highlight the importance of rigorous statistical analysis in real-world pharmacological and biomedical research. This textbook also: Describes the rigorous statistical approach needed for publication in scientific journals Covers a wide range of statistical concepts and methods, such as standard normal distribution, data confidence intervals, and post hoc and a priori analysis Discusses practical aspects of data collection, identification, and presentation Features images of the output from common statistical packages, including GraphPad Prism, Invivo Stat, MiniTab and SPSS Experimental Design and Statistical Analysis for Pharmacology and the Biomedical Sciences is an invaluable reference and guide for undergraduate and graduate students, post-doctoral researchers, and lecturers in pharmacology and allied subjects in the life sciences.
Author: N. Anthony Armstrong
Publisher: CRC Press
ISBN: 9780203483091
Category : Medical
Languages : en
Pages : 294
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Book Description
This work provides a description of the principles of experimental design and their application to pharmaceutical research. It includes worked examples taken from a wide variety of pharmaceutical techniques and processes.
Author: Weichung Joe Shih
Publisher: CRC Press
ISBN: 1000462811
Category : Medical
Languages : en
Pages : 320
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Book Description
Statistical Design, Monitoring, and Analysis of Clinical Trials, Second Edition concentrates on the biostatistics component of clinical trials. This new edition is updated throughout and includes five new chapters. Developed from the authors’ courses taught to public health and medical students, residents, and fellows during the past 20 years, the text shows how biostatistics in clinical trials is an integration of many fundamental scientific principles and statistical methods. The book begins with ethical and safety principles, core trial design concepts, the principles and methods of sample size and power calculation, and analysis of covariance and stratified analysis. It then focuses on sequential designs and methods for two-stage Phase II cancer trials to Phase III group sequential trials, covering monitoring safety, futility, and efficacy. The authors also discuss the development of sample size reestimation and adaptive group sequential procedures, phase 2/3 seamless design and trials with predictive biomarkers, exploit multiple testing procedures, and explain the concept of estimand, intercurrent events, and different missing data processes, and describe how to analyze incomplete data by proper multiple imputations. This text reflects the academic research, commercial development, and public health aspects of clinical trials. It gives students and practitioners a multidisciplinary understanding of the concepts and techniques involved in designing, monitoring, and analyzing various types of trials. The book’s balanced set of homework assignments and in-class exercises are appropriate for students and researchers in (bio)statistics, epidemiology, medicine, pharmacy, and public health.
Author: C. Ralph Buncher
Publisher: CRC Press
ISBN: 142005645X
Category : Mathematics
Languages : en
Pages : 497
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Book Description
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: Weichung Joe Shih
Publisher: CRC Press
ISBN: 1482250500
Category : Mathematics
Languages : en
Pages : 240
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Book Description
Statistical Design and Analysis of Clinical Trials: Principles and Methods concentrates on the biostatistics component of clinical trials. Developed from the authors' courses taught to public health and medical students, residents, and fellows during the past 15 years, the text shows how biostatistics in clinical trials is an integration of many fu
