statistics in clinical vaccine trials

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Statistics In Clinical Vaccine Trials

Author : Jozef Nauta
ISBN : 3642146910
Genre : Mathematics
File Size : 60. 7 MB
Format : PDF, Kindle
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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.

Statistics In Clinical Vaccine Trials

Author : Jozef Nauta
ISBN : 3642146902
Genre : Mathematics
File Size : 78. 74 MB
Format : PDF, ePub, Docs
Download : 268
Read : 180

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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.

Bioequivalence And Statistics In Clinical Pharmacology Second Edition

Author : Scott D. Patterson
ISBN : 9781466585218
Genre : Mathematics
File Size : 62. 99 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.

Design And Analysis Of Vaccine Studies

Author : M. Elizabeth Halloran
ISBN : 9780387686363
Genre : Medical
File Size : 81. 28 MB
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As well as being a reference for the design, analysis, and interpretation of vaccine studies, the text covers all design and analysis stages, from vaccine development to post-licensure surveillance, presenting likelihood, frequentists, and Bayesian approaches.

Bioequivalence And Statistics In Clinical Pharmacology Second Edition

Author : Scott D. Patterson
ISBN : 146658520X
Genre :
File Size : 72. 29 MB
Format : PDF, Mobi
Download : 457
Read : 214

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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. "

Biostatistics In Clinical Trials

Author : Carol K. Redmond
ISBN : 0471822116
Genre : Medical
File Size : 81. 8 MB
Format : PDF
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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.

Bayesian Approaches To Clinical Trials And Health Care Evaluation

Author : David J. Spiegelhalter
ISBN : 0471499757
Genre : Mathematics
File Size : 75. 75 MB
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The Bayesian approach involves collecting data from past experience in order to reach conclusions about future events. This introduction covers a broad array of topics. It is for statisticians in the pharmaceutical industry, as well as anyone involved in conducting clinical trials and HTA work.

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