Statistical Methods For Immunogenicity Assessment

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Statistical Methods For Immunogenicity Assessment

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Author : Harry Yang
language : en
Publisher: CRC Press
Release Date : 2015-07-17

Statistical Methods For Immunogenicity Assessment written by Harry Yang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-07-17 with Mathematics categories.

Develop Effective Immunogenicity Risk Mitigation StrategiesImmunogenicity 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 stra

Methods In Comparative Effectiveness Research

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Author : Constantine Gatsonis
language : en
Publisher: CRC Press
Release Date : 2017-02-24

Methods In Comparative Effectiveness Research written by Constantine Gatsonis and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-02-24 with Mathematics categories.

Comparative effectiveness research (CER) is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care (IOM 2009). CER is conducted to develop evidence that will aid patients, clinicians, purchasers, and health policy makers in making informed decisions at both the individual and population levels. CER encompasses a very broad range of types of studies—experimental, observational, prospective, retrospective, and research synthesis. This volume covers the main areas of quantitative methodology for the design and analysis of CER studies. The volume has four major sections—causal inference; clinical trials; research synthesis; and specialized topics. The audience includes CER methodologists, quantitative-trained researchers interested in CER, and graduate students in statistics, epidemiology, and health services and outcomes research. The book assumes a masters-level course in regression analysis and familiarity with clinical research.

Applied Biclustering Methods For Big And High Dimensional Data Using R

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Author : Adetayo Kasim
language : en
Publisher: CRC Press
Release Date : 2016-10-03

Applied Biclustering Methods For Big And High Dimensional Data Using R written by Adetayo Kasim and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-10-03 with Mathematics categories.

Proven Methods for Big Data Analysis As big data has become standard in many application areas, challenges have arisen related to methodology and software development, including how to discover meaningful patterns in the vast amounts of data. Addressing these problems, Applied Biclustering Methods for Big and High-Dimensional Data Using R shows how to apply biclustering methods to find local patterns in a big data matrix. The book presents an overview of data analysis using biclustering methods from a practical point of view. Real case studies in drug discovery, genetics, marketing research, biology, toxicity, and sports illustrate the use of several biclustering methods. References to technical details of the methods are provided for readers who wish to investigate the full theoretical background. All the methods are accompanied with R examples that show how to conduct the analyses. The examples, software, and other materials are available on a supplementary website.

Statistical Topics In Health Economics And Outcomes Research

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Author : Demissie Alemayehu, PhD
language : en
Publisher: CRC Press
Release Date : 2017-11-22

Statistical Topics In Health Economics And Outcomes Research written by Demissie Alemayehu, PhD and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-11-22 with Mathematics categories.

With ever-rising healthcare costs, evidence generation through Health Economics and Outcomes Research (HEOR) plays an increasingly important role in decision-making about the allocation of resources. Accordingly, it is now customary for health technology assessment and reimbursement agencies to request for HEOR evidence, in addition to data from clinical trials, to inform decisions about patient access to new treatment options. While there is a great deal of literature on HEOR, there is a need for a volume that presents a coherent and unified review of the major issues that arise in application, especially from a statistical perspective. Statistical Topics in Health Economics and Outcomes Research fulfils that need by presenting an overview of the key analytical issues and best practice. Special attention is paid to key assumptions and other salient features of statistical methods customarily used in the area, and appropriate and relatively comprehensive references are made to emerging trends. The content of the book is purposefully designed to be accessible to readers with basic quantitative backgrounds, while providing an in-depth coverage of relatively complex statistical issues. The book will make a very useful reference for researchers in the pharmaceutical industry, academia, and research institutions involved with HEOR studies. The targeted readers may include statisticians, data scientists, epidemiologists, outcomes researchers, health economists, and healthcare policy and decision-makers.

Essentials Of A Successful Biostatistical Collaboration

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Author : Arul Earnest
language : en
Publisher: CRC Press
Release Date : 2016-10-14

Essentials Of A Successful Biostatistical Collaboration written by Arul Earnest and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-10-14 with Mathematics categories.

The aim of this book is to equip biostatisticians and other quantitative scientists with the necessary skills, knowledge, and habits to collaborate effectively with clinicians in the healthcare field. The book provides valuable insight on where to look for information and material on sample size and statistical techniques commonly used in clinical research, and on how best to communicate with clinicians. It also covers the best practices to adopt in terms of project, time, and data management; relationship with collaborators; etc.

Biosimilar Clinical Development Scientific Considerations And New Methodologies

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Author : Kerry B. Barker
language : en
Publisher: CRC Press
Release Date : 2016-11-25

Biosimilar Clinical Development Scientific Considerations And New Methodologies written by Kerry B. Barker and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-11-25 with Mathematics categories.

Biosimilars have the potential to change the way we think about, identify, and manage health problems. They are already impacting both clinical research and patient care, and this impact will only grow as our understanding and technologies improve. Written by a team of experienced specialists in clinical development, this book discusses various potential drug development strategies, the design and analysis of pharmacokinetics (PK) studies, and the design and analysis of efficacy studies.

Repeated Measures Design With Generalized Linear Mixed Models For Randomized Controlled Trials

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Author : Toshiro Tango
language : en
Publisher: CRC Press
Release Date : 2017-09-14

Repeated Measures Design With Generalized Linear Mixed Models For Randomized Controlled Trials written by Toshiro Tango and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-09-14 with Mathematics categories.

Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials is the first book focused on the application of generalized linear mixed models and its related models in the statistical design and analysis of repeated measures from randomized controlled trials. The author introduces a new repeated measures design called S:T design combined with mixed models as a practical and useful framework of parallel group RCT design because of easy handling of missing data and sample size reduction. The book emphasizes practical, rather than theoretical, aspects of statistical analyses and the interpretation of results. It includes chapters in which the author describes some old-fashioned analysis designs that have been in the literature and compares the results with those obtained from the corresponding mixed models. The book will be of interest to biostatisticians, researchers, and graduate students in the medical and health sciences who are involved in clinical trials. Author Website:Data sets and programs used in the book are available at http://www.medstat.jp/downloadrepeatedcrc.html

Analyzing Longitudinal Clinical Trial Data

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Author : Craig Mallinckrodt
language : en
Publisher: CRC Press
Release Date : 2016-12-12

Analyzing Longitudinal Clinical Trial Data written by Craig Mallinckrodt and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-12-12 with Mathematics categories.

Analyzing Longitudinal Clinical Trial Data: A Practical Guide provides practical and easy to implement approaches for bringing the latest theory on analysis of longitudinal clinical trial data into routine practice.The book, with its example-oriented approach that includes numerous SAS and R code fragments, is an essential resource for statisticians and graduate students specializing in medical research. The authors provide clear descriptions of the relevant statistical theory and illustrate practical considerations for modeling longitudinal data. Topics covered include choice of endpoint and statistical test; modeling means and the correlations between repeated measurements; accounting for covariates; modeling categorical data; model verification; methods for incomplete (missing) data that includes the latest developments in sensitivity analyses, along with approaches for and issues in choosing estimands; and means for preventing missing data. Each chapter stands alone in its coverage of a topic. The concluding chapters provide detailed advice on how to integrate these independent topics into an over-arching study development process and statistical analysis plan.

Emerging Non Clinical Biostatistics In Biopharmaceutical Development And Manufacturing

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Author : Harry Yang
language : en
Publisher: CRC Press
Release Date : 2016-11-30

Emerging Non Clinical Biostatistics In Biopharmaceutical Development And Manufacturing written by Harry Yang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-11-30 with Mathematics categories.

The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing process. This state-of-the-art book provides a single source of information on emerging statistical approaches to QbD and risk-based pharmaceutical development. A comprehensive resource, it combines in-depth explanations of advanced statistical methods with real-life case studies that illustrate practical applications of these methods in QbD implementation.

Fundamental Concepts For New Clinical Trialists

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Author : Scott Evans
language : en
Publisher: CRC Press
Release Date : 2015-11-04

Fundamental Concepts For New Clinical Trialists written by Scott Evans and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-11-04 with Mathematics categories.

Fundamental Concepts for New Clinical Trialists describes the core scientific concepts of designing, data monitoring, analyzing, and reporting clinical trials as well as the practical aspects of trials not typically discussed in statistical methodology textbooks. The first section of the book provides background information about clinical trials. I