Author: Karl E. Peace
Publisher: CRC Press
ISBN: 1482277123
Category : Mathematics
Languages : en
Pages : 377
Book Description
Focusing on group sequential procedures, summarizes the sequential statistical methods used in anticancer, antiviral, cardiovascular, and gastrointestinal drug research and screening. The clinical and preclinical applications are mainly presented as case studies, many of which form part of New Drug
Biopharmaceutical Sequential Statistical Applications
Author: Karl E. Peace
Publisher: CRC Press
ISBN: 1482277123
Category : Mathematics
Languages : en
Pages : 377
Book Description
Focusing on group sequential procedures, summarizes the sequential statistical methods used in anticancer, antiviral, cardiovascular, and gastrointestinal drug research and screening. The clinical and preclinical applications are mainly presented as case studies, many of which form part of New Drug
Publisher: CRC Press
ISBN: 1482277123
Category : Mathematics
Languages : en
Pages : 377
Book Description
Focusing on group sequential procedures, summarizes the sequential statistical methods used in anticancer, antiviral, cardiovascular, and gastrointestinal drug research and screening. The clinical and preclinical applications are mainly presented as case studies, many of which form part of New Drug
Statistics In the Pharmaceutical Industry
Author: C. Ralph Buncher
Publisher: CRC Press
ISBN: 142005645X
Category : Mathematics
Languages : en
Pages : 497
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.
Publisher: CRC Press
ISBN: 142005645X
Category : Mathematics
Languages : en
Pages : 497
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.
Encyclopedia of Biopharmaceutical Statistics - Four Volume Set
Author: Shein-Chung Chow
Publisher: CRC Press
ISBN: 1351110268
Category : Medical
Languages : en
Pages : 2434
Book Description
Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences. Features of the Fourth Edition: 1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters. 2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies. 3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development. 4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics. About the Editor: Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.
Publisher: CRC Press
ISBN: 1351110268
Category : Medical
Languages : en
Pages : 2434
Book Description
Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences. Features of the Fourth Edition: 1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters. 2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies. 3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development. 4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics. About the Editor: Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.
Epidemiology
Author: Mark Woodward
Publisher: CRC Press
ISBN: 9781584880097
Category : Mathematics
Languages : en
Pages : 728
Book Description
Epidemiology is a subject of growing importance, as witnessed by its role in the description and prediction of the impact of new diseases such as AIDS and new-variant CJD. Epidemiology: Study Design and Data Analysis covers the whole spectrum of standard analytical techniques used in epidemiology, from descriptive techniques in report writing to model diagnostics from generalized linear models. The author discusses the advantages, disadvantages, and alternatives to case-control, cohort and intervention studies and details such crucial concepts as incidence, prevalence, confounding and interaction. Many exercises are provided, based on real epidemiological data sets collected from all over the world. The data sets are also available on an associated web site. Epidemiology: Study Design and Data Analysis will be an invaluable textbook for statistics and medical students studying epidemiology, and a standard reference for practicing epidemiologists.
Publisher: CRC Press
ISBN: 9781584880097
Category : Mathematics
Languages : en
Pages : 728
Book Description
Epidemiology is a subject of growing importance, as witnessed by its role in the description and prediction of the impact of new diseases such as AIDS and new-variant CJD. Epidemiology: Study Design and Data Analysis covers the whole spectrum of standard analytical techniques used in epidemiology, from descriptive techniques in report writing to model diagnostics from generalized linear models. The author discusses the advantages, disadvantages, and alternatives to case-control, cohort and intervention studies and details such crucial concepts as incidence, prevalence, confounding and interaction. Many exercises are provided, based on real epidemiological data sets collected from all over the world. The data sets are also available on an associated web site. Epidemiology: Study Design and Data Analysis will be an invaluable textbook for statistics and medical students studying epidemiology, and a standard reference for practicing epidemiologists.
Multiple Comparisons, Selection and Applications in Biometry
Author: Fred. M. Hoppe
Publisher: CRC Press
ISBN: 1000104923
Category : Mathematics
Languages : en
Pages : 576
Book Description
Aims to provide in-depth descriptions of the latest developments in multiple comparison methods and selection procedures, while emphasizing biometry. This text is published in honour of the 70th birthday of Charles W. Dunnett - a pioneer in statistical methodology.
Publisher: CRC Press
ISBN: 1000104923
Category : Mathematics
Languages : en
Pages : 576
Book Description
Aims to provide in-depth descriptions of the latest developments in multiple comparison methods and selection procedures, while emphasizing biometry. This text is published in honour of the 70th birthday of Charles W. Dunnett - a pioneer in statistical methodology.
Advances In Animal Alternatives For Safety And Efficacy Testing
Author: Harry Salem
Publisher: CRC Press
ISBN: 9781439805817
Category : Medical
Languages : en
Pages : 474
Book Description
Presents up-to-date concepts and approaches to the theory and practice of alternatives to animal testing and promotes technology transfer. The text addresses some of the ramifications of the National Institutes of Health Revitalization Act of 1993 which instructs the NIH to fund replacement, reduction and refinement alternatives. It also describes
Publisher: CRC Press
ISBN: 9781439805817
Category : Medical
Languages : en
Pages : 474
Book Description
Presents up-to-date concepts and approaches to the theory and practice of alternatives to animal testing and promotes technology transfer. The text addresses some of the ramifications of the National Institutes of Health Revitalization Act of 1993 which instructs the NIH to fund replacement, reduction and refinement alternatives. It also describes
Computational Methods in Statistics and Econometrics
Author: Hisashi Tanizaki
Publisher: CRC Press
ISBN: 0824750888
Category : Mathematics
Languages : en
Pages : 534
Book Description
Reflecting current technological capacities and analytical trends, Computational Methods in Statistics and Econometrics showcases Monte Carlo and nonparametric statistical methods for models, simulations, analyses, and interpretations of statistical and econometric data. The author explores applications of Monte Carlo methods in Bayesian estimation, state space modeling, and bias correction of ordinary least squares in autoregressive models. The book offers straightforward explanations of mathematical concepts, hundreds of figures and tables, and a range of empirical examples. A CD-ROM packaged with the book contains all of the source codes used in the text.
Publisher: CRC Press
ISBN: 0824750888
Category : Mathematics
Languages : en
Pages : 534
Book Description
Reflecting current technological capacities and analytical trends, Computational Methods in Statistics and Econometrics showcases Monte Carlo and nonparametric statistical methods for models, simulations, analyses, and interpretations of statistical and econometric data. The author explores applications of Monte Carlo methods in Bayesian estimation, state space modeling, and bias correction of ordinary least squares in autoregressive models. The book offers straightforward explanations of mathematical concepts, hundreds of figures and tables, and a range of empirical examples. A CD-ROM packaged with the book contains all of the source codes used in the text.
Handbook Of Applied Econometrics And Statistical Inference
Author: Aman Ullah
Publisher: CRC Press
ISBN: 9780203911075
Category : Business & Economics
Languages : en
Pages : 754
Book Description
Summarizing developments and techniques in the field, this reference covers sample surveys, nonparametric analysis, hypothesis testing, time series analysis, Bayesian inference, and distribution theory for applications in statistics, economics, medicine, biology, engineering, sociology, psychology, and information technology. It supplies a geometric proof of an extended Gauss-Markov theorem, approaches for the design and implementation of sample surveys, advances in the theory of Neyman's smooth test, and methods for pre-test and biased estimation. It includes discussions ofsample size requirements for estimation in SUR models, innovative developments in nonparametric models, and more.
Publisher: CRC Press
ISBN: 9780203911075
Category : Business & Economics
Languages : en
Pages : 754
Book Description
Summarizing developments and techniques in the field, this reference covers sample surveys, nonparametric analysis, hypothesis testing, time series analysis, Bayesian inference, and distribution theory for applications in statistics, economics, medicine, biology, engineering, sociology, psychology, and information technology. It supplies a geometric proof of an extended Gauss-Markov theorem, approaches for the design and implementation of sample surveys, advances in the theory of Neyman's smooth test, and methods for pre-test and biased estimation. It includes discussions ofsample size requirements for estimation in SUR models, innovative developments in nonparametric models, and more.
Statistics for the 21st Century
Author: Gabor Szekely
Publisher: CRC Press
ISBN: 1482277492
Category : Mathematics
Languages : en
Pages : 500
Book Description
A selection of articles presented at the Eighth Lukacs Symposium held at the Bowling Green State University, Ohio. They discuss consistency and accuracy of the sequential bootstrap, hypothesis testing, geometry in multivariate analysis, the classical extreme value model, the analysis of cross-classified data, diffusion models for neural activity, e
Publisher: CRC Press
ISBN: 1482277492
Category : Mathematics
Languages : en
Pages : 500
Book Description
A selection of articles presented at the Eighth Lukacs Symposium held at the Bowling Green State University, Ohio. They discuss consistency and accuracy of the sequential bootstrap, hypothesis testing, geometry in multivariate analysis, the classical extreme value model, the analysis of cross-classified data, diffusion models for neural activity, e
Computer-Aided Econometrics
Author: David E. A. Giles
Publisher: CRC Press
ISBN: 9780203911570
Category : Business & Economics
Languages : en
Pages : 556
Book Description
Emphasizing the impact of computer software and computational technology on econometric theory and development, this text presents recent advances in the application of computerized tools to econometric techniques and practices—focusing on current innovations in Monte Carlo simulation, computer-aided testing, model selection, and Bayesian methodology for improved econometric analyses.
Publisher: CRC Press
ISBN: 9780203911570
Category : Business & Economics
Languages : en
Pages : 556
Book Description
Emphasizing the impact of computer software and computational technology on econometric theory and development, this text presents recent advances in the application of computerized tools to econometric techniques and practices—focusing on current innovations in Monte Carlo simulation, computer-aided testing, model selection, and Bayesian methodology for improved econometric analyses.