statistics in clinical vaccine trials

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Statistics In Clinical Vaccine Trials

Author : Jozef Nauta
ISBN : 3642146910
Genre : Mathematics
File Size : 39. 91 MB
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This monograph offers well-founded training and expertise on the statistical analysis of data from clinical vaccine trials, i.e., immunogenicity and vaccine field efficacy studies. The book's scope is practical rather than theoretical. It opens with two introductory chapters on the immunology of vaccines to provide readers with the necessary background knowledge. It then continues with an in-depth exploration of the statistical methodology. Many real-life examples and SAS codes are presented, making application of the methods straightforward. Topics discussed include maximum likelihood estimation for censored antibody titers, ANCOVA for antibody values, analysis of equivalence and non-inferiority immunogenicity trial data, analysis of data from vaccine field efficacy trials (including data from studies with recurrent infection data), fitting protection curves to data of challenge or field efficacy studies, and the analysis of vaccine safety data.

Biostatistics In Clinical Trials

Author : Carol K. Redmond
ISBN : 0471822116
Genre : Medical
File Size : 52. 51 MB
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The second volume in the Wiley reference series in Biostatistics. Featuring articles from the prestigious Encyclopedia of Biostatistics, many of which have been fully revised and updated to include recent developments, Biostatistics in Clinical Trials also includes up to 25% newly commissioned material reflecting the latest thinking in: Bayesian methods Benefit/risk assessment Cost-effectiveness Ethics Fraud With exceptional contributions from leading experts in academia, government and industry, Biostatistics in Clinical Trials has been designed to complement existing texts by providing extensive, up-to-date coverage and introducing the reader to the research literature. Offering comprehensive coverage of all aspects of clinical trials Biostatistics in Clinical Trials: Includes concise definitions and introductions to numerous concepts found in current literature Discusses the software and textbooks available Uses extensive cross-references helping to facilitate further research and enabling the reader to locate definitions and related concepts Biostatistics in Clinical Trials offers both academics and practitioners from various disciplines and settings, such as universities, the pharmaceutical industry and clinical research organisations, up-to-date information as well as references to assist professionals involved in the design and conduct of clinical trials.

Bioequivalence And Statistics In Clinical Pharmacology Second Edition

Author : Scott D. Patterson
ISBN : 9781466585218
Genre : Mathematics
File Size : 28. 3 MB
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Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day clinical pharmacology work. The book is a starting point for those involved in such research and covers the methods needed to design, analyze, and interpret bioequivalence trials; explores when, how, and why these studies are performed as part of drug development; and demonstrates the methods using real world examples. Drawing on knowledge gained directly from working in the pharmaceutical industry, the authors set the stage by describing the general role of statistics. Once the foundation of clinical pharmacology drug development, regulatory applications, and the design and analysis of bioequivalence trials are established,?including recent regulatory changes in design and analysis and in particular sample-size adaptation, they move on to related topics in clinical pharmacology involving the use of cross-over designs. These include, but are not limited to, safety studies in Phase I, dose-response trials, drug interaction trials, food-effect and combination trials, QTc and other pharmacodynamic equivalence trials, proof-of-concept trials, dose-proportionality trials, and vaccines trials.? This second edition addresses several recent developments in the field, including new chapters on adaptive bioequivalence studies, scaled average bioequivalence testing, and vaccine trials. Purposefully designed to be instantly applicable, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition provides examples of SAS and R code so that the analyses described can be immediately implemented. The authors have made extensive use of the proc mixed procedures available in SAS.

Methods And Applications Of Statistics In Clinical Trials Volume 1

Author : N. Balakrishnan
ISBN : 9781118595916
Genre : Medical
File Size : 78. 90 MB
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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.

Design And Analysis Of Clinical Trials

Author : Shein-Chung Chow
ISBN : 9780471473299
Genre : Mathematics
File Size : 53. 29 MB
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Bioequivalence And Statistics In Clinical Pharmacology Second Edition

Author : Scott D. Patterson
ISBN : 146658520X
Genre :
File Size : 46. 27 MB
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Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day clinical pharmacology work. The book is a starting point for those involved in such research and covers the methods needed to design, analyze, and interpret bioequivalence trials; explores when, how, and why these studies are performed as part of drug development; and demonstrates the methods using real world examples. Drawing on knowledge gained directly from working in the pharmaceutical industry, the authors set the stage by describing the general role of statistics. Once the foundation of clinical pharmacology drug development, regulatory applications, and the design and analysis of bioequivalence trials are established, including recent regulatory changes in design and analysis and in particular sample-size adaptation, they move on to related topics in clinical pharmacology involving the use of cross-over designs. These include, but are not limited to, safety studies in Phase I, dose-response trials, drug interaction trials, food-effect and combination trials, QTc and other pharmacodynamic equivalence trials, proof-of-concept trials, dose-proportionality trials, and vaccines trials. This second edition addresses several recent developments in the field, including new chapters on adaptive bioequivalence studies, scaled average bioequivalence testing, and vaccine trials. Purposefully designed to be instantly applicable, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition provides examples of SAS and R code so that the analyses described can be immediately implemented. The authors have made extensive use of the proc mixed procedures available in SAS. "

Statistical Methods For Immunogenicity Assessment

Author : Harry Yang
ISBN : 9781498700351
Genre : Mathematics
File Size : 86. 74 MB
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Develop Effective Immunogenicity Risk Mitigation Strategies Immunogenicity assessment is a prerequisite for the successful development of biopharmaceuticals, including safety and efficacy evaluation. Using advanced statistical methods in the study design and analysis stages is therefore essential to immunogenicity risk assessment and mitigation strategies. Statistical Methods for Immunogenicity Assessment provides a single source of information on statistical concepts, principles, methods, and strategies for detection, quantification, assessment, and control of immunogenicity. The book first gives an overview of the impact of immunogenicity on biopharmaceutical development, regulatory requirements, and statistical methods and strategies used for immunogenicity detection, quantification, and risk assessment and mitigation. It then covers anti-drug antibody (ADA) assay development, optimization, validation, and transfer as well as the analysis of cut point, a key assay performance parameter in ADA assay development and validation. The authors illustrate how to apply statistical modeling approaches to establish associations between ADA and clinical outcomes, predict immunogenicity risk, and develop risk mitigation strategies. They also present various strategies for immunogenicity risk control. The book concludes with an explanation of the computer codes and algorithms of the statistical methods. A critical issue in the development of biologics, immunogenicity can cause early termination or limited use of the products if not managed well. This book shows how to use robust statistical methods for detecting, quantifying, assessing, and mitigating immunogenicity risk. It is an invaluable resource for anyone involved in immunogenicity risk assessment and control in both non-clinical and clinical biopharmaceutical development.

Statistical Analysis Of Human Growth And Development

Author : Yin Bun Cheung
ISBN : 9781439871546
Genre : Mathematics
File Size : 33. 14 MB
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Statistical Analysis of Human Growth and Development is an accessible and practical guide to a wide range of basic and advanced statistical methods that are useful for studying human growth and development. Designed for nonstatisticians and statisticians new to the analysis of growth and development data, the book collects methods scattered throughout the literature and explains how to use them to solve common research problems. It also discusses how well a method addresses a specific scientific question and how to interpret and present the analytic results. Stata is used to implement the analyses, with Stata codes and macros for generating example data sets, a detrended Q-Q plot, and weighted maximum likelihood estimation of binary items available on the book’s CRC Press web page. After reviewing research designs and basic statistical tools, the author discusses the use of existing tools to transform raw data into analyzable variables and back-transform them to raw data. He covers regression analysis of quantitative, binary, and censored data as well as the analysis of repeated measurements and clustered data. He also describes the development of new growth references and developmental indices, the generation of key variables based on longitudinal data, and the processes to verify the validity and reliability of measurement tools. Looking at the larger picture of research practice, the book concludes with coverage of missing values, multiplicity problems, and multivariable regression. Along with two simulated data sets, numerous examples from real experimental and observational studies illustrate the concepts and methods. Although the book focuses on examples of anthropometric measurements and changes in cognitive, social-emotional, locomotor, and other abilities, the ideas are applicable to many other physical and psychosocial phenomena, such as lung function and depressive symptoms.

Methods And Applications Of Statistics In Clinical Trials Volume 2

Author : N. Balakrishnan
ISBN : 9781118595961
Genre : Medical
File Size : 69. 87 MB
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Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and Inferential Methods includes updates of established literature from the Wiley Encyclopedia of Clinical Trials as well as original material based on the latest developments in clinical trials. Prepared by a leading expert, the second volume includes numerous contributions from current prominent experts in the field of medical research. In addition, the volume features: • Multiple new articles exploring emerging topics, such as evaluation methods with threshold, empirical likelihood methods, nonparametric ROC analysis, over- and under-dispersed models, and multi-armed bandit problems • Up-to-date research on the Cox proportional hazard model, frailty models, trial reports, intrarater reliability, conditional power, and the kappa index • Key qualitative issues including cost-effectiveness analysis, publication bias, and regulatory issues, which are crucial to the planning and data management of clinical trials

Methodik Klinischer Studien

Author : Martin Schumacher
ISBN : 9783662087190
Genre : Medical
File Size : 24. 9 MB
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Das Buch bietet eine praxisorientierte Einführung in die methodischen Grundlagen klinischer Studien in der wissenschaftlichen Forschung und der pharmazeutischen Industrie. Die grundlegenden Prinzipien der Planung und Durchführung klinischer Studien sowie die wichtigsten statistischen Verfahren für deren Auswertung werden in verständlicher Weise dargestellt und erklärt. Neben der Methodik für Therapiestudien werden auch die speziellen Verfahren in Diagnose- und Prognosestudien behandelt. Anhand von Beispielen konkreter Studien, vorwiegend aus dem Arbeitsumfeld der Autoren, werden die Prinzipien und Methoden anschaulich illustriert und die in der Praxis auftretenden Probleme exemplarisch aufgezeigt. Historische Entwicklungen sowie die aktuellen Anforderungen an die Qualität klinischer Studien werden dargestellt und diskutiert. Das Buch richtet sich an alle, die klinische Studien planen, durchführen und statistisch auswerten.

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