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Exposure Response Modeling

Exposure   Response Modeling Author Jixian Wang
ISBN-10 9781466573215
Release 2015-07-17
Pages 351
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Discover the Latest Statistical Approaches for Modeling Exposure-Response Relationships Written by an applied statistician with extensive practical experience in drug development, Exposure-Response Modeling: Methods and Practical Implementation explores a wide range of topics in exposure-response modeling, from traditional pharmacokinetic-pharmacodynamic (PKPD) modeling to other areas in drug development and beyond. It incorporates numerous examples and software programs for implementing novel methods. The book describes using measurement error models to treat sequential modeling, fitting models with exposure and response driven by complex dynamics, and survival analysis with dynamic exposure history. It also covers Bayesian analysis and model-based Bayesian decision analysis, causal inference to eliminate confounding biases, and exposure-response modeling with response-dependent dose/treatment adjustments (dynamic treatment regimes) for personalized medicine and treatment adaptation. Many examples illustrate the use of exposure-response modeling in experimental toxicology, clinical pharmacology, epidemiology, and drug safety. Some examples demonstrate how to solve practical problems while others help with understanding concepts and evaluating the performance of new methods. The provided SAS and R codes enable readers to test the approaches in their own scenarios. Although application oriented, this book also gives a systematic treatment of concepts and methodology. Applied statisticians and modelers can find details on how to implement new approaches. Researchers can find topics for or applications of their work. In addition, students can see how complicated methodology and models are applied to practical situations.

Applied Pharmacometrics

Applied Pharmacometrics Author Stephan Schmidt
ISBN-10 9781493913046
Release 2014-12-01
Pages 565
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This comprehensive volume provides an update on the current state of pharmacometrics in drug development. It consists of nineteen chapters all written by leading scientists from the pharmaceutical industry, regulatory agencies and academia. After an introduction of the basic pharmacokinetic and pharmacodynamic concepts of pharmacometrics in drug development, the book presents numerous examples of specific applications that utilize pharmacometrics with modeling and simulations over a variety of therapeutic areas, including pediatrics, diabetes, obesity, infections, psychiatrics, Alzheimer’s disease, and dermatology, among others. The examples illustrate how results from all phases of drug development can be integrated in a more timely and cost-effective process. Applying pharmacometric decision tools during drug development can allow objective, data-based decision making. At the same time, the process can identify redundant or unnecessary experiments as well as some costly clinical trials that can be avoided. In addition to cost saving by expedited development of successful drug candidates, pharmacometrics has an important economic impact in drug product selection. Unsuccessful drug candidates can be identified early and discontinued without expending efforts required for additional studies and allocating limited resources. Hence, pharmacometric modeling and simulation has become a powerful tool to bring new and better medications to the patient at a faster pace and with greater probability of success.

Meta Analysis in Medicine and Health Policy

Meta Analysis in Medicine and Health Policy Author Dalene Stangl
ISBN-10 0203909933
Release 2000-04-20
Pages 414
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This remarkable text raises the analysis of data in health sciences and policy to new heights of refinement and applicability by introducing cutting-edge meta-analysis strategies while reviewing more commonly used techniques. Each chapter builds on sound principles, develops methodologies to solve statistical problems, and presents concrete applications used by experienced medical practitioners and health policymakers. Written by more than 30 celebrated international experts, Meta-Analysis in Medicine and Health Policy employs copious examples and pictorial presentations to teach and reinforce biostatistical techniques more effectively and poses numerous open questions of medical and health policy research.

ADME and Translational Pharmacokinetics Pharmacodynamics of Therapeutic Proteins

ADME and Translational Pharmacokinetics   Pharmacodynamics of Therapeutic Proteins Author Honghui Zhou
ISBN-10 9781118898802
Release 2015-10-26
Pages 472
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With an emphasis on the fundamental and practical aspects of ADME for therapeutic proteins, this book helps readers strategize, plan and implement translational research for biologic drugs. • Details cutting-edge ADME (absorption, distribution, metabolism and excretion) and PKPD (pharmacokinetic / pharmacodynamics) modeling for biologic drugs • Combines theoretical with practical aspects of ADME in biologic drug discovery and development and compares innovator biologics with biosimilar biologics and small molecules with biologics, giving a lessons-learned perspective • Includes case studies about leveraging ADME to improve biologics drug development for monoclonal antibodies, fusion proteins, pegylated proteins, ADCs, bispecifics, and vaccines • Presents regulatory expectations and industry perspectives for developing biologic drugs in USA, EU, and Japan • Provides mechanistic insight into biodistribution and target-driven pharmacokinetics in important sites of action such as tumors and the brain

The R Book

The R Book Author Michael J. Crawley
ISBN-10 9781118448960
Release 2012-11-07
Pages 1080
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Hugely successful and popular text presenting an extensive and comprehensive guide for all R users The R language is recognized as one of the most powerful and flexible statistical software packages, enabling users to apply many statistical techniques that would be impossible without such software to help implement such large data sets. R has become an essential tool for understanding and carrying out research. This edition: Features full colour text and extensive graphics throughout. Introduces a clear structure with numbered section headings to help readers locate information more efficiently. Looks at the evolution of R over the past five years. Features a new chapter on Bayesian Analysis and Meta-Analysis. Presents a fully revised and updated bibliography and reference section. Is supported by an accompanying website allowing examples from the text to be run by the user. Praise for the first edition: ‘…if you are an R user or wannabe R user, this text is the one that should be on your shelf. The breadth of topics covered is unsurpassed when it comes to texts on data analysis in R.’ (The American Statistician, August 2008) ‘The High-level software language of R is setting standards in quantitative analysis. And now anybody can get to grips with it thanks to The R Book…’ (Professional Pensions, July 2007)

Handbook of Methods for Designing Monitoring and Analyzing Dose Finding Trials

Handbook of Methods for Designing  Monitoring  and Analyzing Dose Finding Trials Author John O'Quigley
ISBN-10 9781351648028
Release 2017-04-27
Pages 320
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Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials gives a thorough presentation of state-of-the-art methods for early phase clinical trials. The methodology of clinical trials has advanced greatly over the last 20 years and, arguably, nowhere greater than that of early phase studies. The need to accelerate drug development in a rapidly evolving context of targeted therapies, immunotherapy, combination treatments and complex group structures has provided the stimulus to these advances. Typically, we deal with very small samples, sequential methods that need to be efficient, while, at the same time adhering to ethical principles due to the involvement of human subjects. Statistical inference is difficult since the standard techniques of maximum likelihood do not usually apply as a result of model misspecification and parameter estimates lying on the boundary of the parameter space. Bayesian methods play an important part in overcoming these difficulties, but nonetheless, require special consideration in this particular context. The purpose of this handbook is to provide an expanded summary of the field as it stands and also, through discussion, provide insights into the thinking of leaders in the field as to the potential developments of the years ahead. With this goal in mind we present: An introduction to the field for graduate students and novices A basis for more established researchers from which to build A collection of material for an advanced course in early phase clinical trials A comprehensive guide to available methodology for practicing statisticians on the design and analysis of dose-finding experiments An extensive guide for the multiple comparison and modeling (MCP-Mod) dose-finding approach, adaptive two-stage designs for dose finding, as well as dose–time–response models and multiple testing in the context of confirmatory dose-finding studies.? John O’Quigley is a professor of mathematics and research director at the French National Institute for Health and Medical Research based at the Faculty of Mathematics, University Pierre and Marie Curie in Paris, France. He is author of Proportional Hazards Regression and has published extensively in the field of dose finding. Alexia Iasonos is an associate attending biostatistician at the Memorial Sloan Kettering Cancer Center in New York. She has over one hundred publications in the leading statistical and clinical journals on the methodology and design of early phase clinical trials. Dr. Iasonos has wide experience in the actual implementation of model based early phase trials and has given courses in scientific meetings internationally. Björn Bornkamp is a statistical methodologist at Novartis in Basel, Switzerland, researching and implementing dose-finding designs in Phase II clinical trials. He is one of the co-developers of the MCP-Mod methodology for dose finding and main author of the DoseFinding R package. He has published numerous papers on dose finding, nonlinear models and Bayesian statistics, and in 2013 won the Royal Statistical Society award for statistical excellence in the pharmaceutical industry. ? ?

Spatio Temporal Methods in Environmental Epidemiology

Spatio Temporal Methods in Environmental Epidemiology Author Gavin Shaddick
ISBN-10 9781482237047
Release 2015-06-17
Pages 395
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Teaches Students How to Perform Spatio-Temporal Analyses within Epidemiological Studies Spatio-Temporal Methods in Environmental Epidemiology is the first book of its kind to specifically address the interface between environmental epidemiology and spatio-temporal modeling. In response to the growing need for collaboration between statisticians and environmental epidemiologists, the book links recent developments in spatio-temporal methodology with epidemiological applications. Drawing on real-life problems, it provides the necessary tools to exploit advances in methodology when assessing the health risks associated with environmental hazards. The book’s clear guidelines enable the implementation of the methodology and estimation of risks in practice. Designed for graduate students in both epidemiology and statistics, the text covers a wide range of topics, from an introduction to epidemiological principles and the foundations of spatio-temporal modeling to new research directions. It describes traditional and Bayesian approaches and presents the theory of spatial, temporal, and spatio-temporal modeling in the context of its application to environmental epidemiology. The text includes practical examples together with embedded R code, details of specific R packages, and the use of other software, such as WinBUGS/OpenBUGS and integrated nested Laplace approximations (INLA). A supplementary website provides additional code, data, examples, exercises, lab projects, and more. Representing a major new direction in environmental epidemiology, this book—in full color throughout—underscores the increasing need to consider dependencies in both space and time when modeling epidemiological data. Students will learn how to identify and model patterns in spatio-temporal data as well as exploit dependencies over space and time to reduce bias and inefficiency.

Optimal Design for Nonlinear Response Models

Optimal Design for Nonlinear Response Models Author Valerii V. Fedorov
ISBN-10 9781439821510
Release 2013-07-15
Pages 402
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Optimal Design for Nonlinear Response Models discusses the theory and applications of model-based experimental design with a strong emphasis on biopharmaceutical studies. The book draws on the authors’ many years of experience in academia and the pharmaceutical industry. While the focus is on nonlinear models, the book begins with an explanation of the key ideas, using linear models as examples. Applying the linearization in the parameter space, it then covers nonlinear models and locally optimal designs as well as minimax, optimal on average, and Bayesian designs. The authors also discuss adaptive designs, focusing on procedures with non-informative stopping. The common goals of experimental design—such as reducing costs, supporting efficient decision making, and gaining maximum information under various constraints—are often the same across diverse applied areas. Ethical and regulatory aspects play a much more prominent role in biological, medical, and pharmaceutical research. The authors address all of these issues through many examples in the book.

Bayesian Regression Modeling with INLA

Bayesian Regression Modeling with INLA Author Xiaofeng Wang
ISBN-10 9781351165747
Release 2018-01-29
Pages 312
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This book addresses the applications of extensively used regression models under a Bayesian framework. It emphasizes efficient Bayesian inference through integrated nested Laplace approximations (INLA) and real data analysis using R. The INLA method directly computes very accurate approximations to the posterior marginal distributions and is a promising alternative to Markov chain Monte Carlo (MCMC) algorithms, which come with a range of issues that impede practical use of Bayesian models.

Handbook of Health Survey Methods

Handbook of Health Survey Methods Author Timothy P. Johnson
ISBN-10 9781118594742
Release 2014-10-13
Pages 840
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A comprehensive guidebook to the current methodologies and practices used in health surveys A unique and self-contained resource, Handbook of Health Survey Methods presents techniques necessary for confronting challenges that are specific to health survey research. The handbook guides readers through the development of sample designs, data collection procedures, and analytic methods for studies aimed at gathering health information on general and targeted populations. The book is organized into five well-defined sections: Design and Sampling Issues, Measurement Issues, Field Issues, Health Surveys of Special Populations, and Data Management and Analysis. Maintaining an easy-to-follow format, each chapter begins with an introduction, followed by an overview of the main concepts, theories, and applications associated with each topic. Finally, each chapter provides connections to relevant online resources for additional study and reference. The Handbook of Health Survey Methods features: 29 methodological chapters written by highly qualified experts in academia, research, and industry A treatment of the best statistical practices and specific methodologies for collecting data from special populations such as sexual minorities, persons with disabilities, patients, and practitioners Discussions on issues specific to health research including developing physical health and mental health measures, collecting information on sensitive topics, sampling for clinical trials, collecting biospecimens, working with proxy respondents, and linking health data to administrative and other external data sources Numerous real-world examples from the latest research in the fields of public health, biomedicine, and health psychology Handbook of Health Survey Methods is an ideal reference for academics, researchers, and practitioners who apply survey methods and analyze data in the fields of biomedicine, public health, epidemiology, and biostatistics. The handbook is also a useful supplement for upper-undergraduate and graduate-level courses on survey methodology.

A First Course in Bayesian Statistical Methods

A First Course in Bayesian Statistical Methods Author Peter D. Hoff
ISBN-10 0387924078
Release 2009-06-02
Pages 272
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A self-contained introduction to probability, exchangeability and Bayes’ rule provides a theoretical understanding of the applied material. Numerous examples with R-code that can be run "as-is" allow the reader to perform the data analyses themselves. The development of Monte Carlo and Markov chain Monte Carlo methods in the context of data analysis examples provides motivation for these computational methods.

Physiologically Based Pharmacokinetic PBPK Modeling and Simulations

Physiologically Based Pharmacokinetic  PBPK  Modeling and Simulations Author Sheila Annie Peters
ISBN-10 9781118140307
Release 2012-02-17
Pages 450
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The only book dedicated to physiologically-based pharmacokinetic modeling in pharmaceutical science Physiologically-based pharmacokinetic (PBPK) modeling has become increasingly widespread within the pharmaceutical industry over the last decade, but without one dedicated book that provides the information researchers need to learn these new techniques, its applications are severely limited. Describing the principles, methods, and applications of PBPK modeling as used in pharmaceutics, Physiologically-Based Pharmacokinetic (PBPK) Modeling and Simulations fills this void. Connecting theory with practice, the book explores the incredible potential of PBPK modeling for improving drug discovery and development. Comprised of two parts, the book first provides a detailed and systematic treatment of the principles behind physiological modeling of pharmacokinetic processes, inter-individual variability, and drug interactions for small molecule drugs and biologics. The second part looks in greater detail at the powerful applications of PBPK to drug research. Designed for a wide audience encompassing readers looking for a brief overview of the field as well as those who need more detail, the book includes a range of important learning aids. Featuring end-of-chapter keywords for easy reference—a valuable asset for general or novice readers without a PBPK background—along with an extensive bibliography for those looking for further information, Physiologically- Based Pharmacokinetic (PBPK) Modeling and Simulations is the essential single-volume text on one of the hottest topics in the pharmaceutical sciences today.

Introduction to Population Pharmacokinetic Pharmacodynamic Analysis with Nonlinear Mixed Effects Models

Introduction to Population Pharmacokinetic   Pharmacodynamic Analysis with Nonlinear Mixed Effects Models Author Joel S. Owen
ISBN-10 9781118784617
Release 2014-06-19
Pages 320
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This book provides a user-friendly, hands-on introduction to the Nonlinear Mixed Effects Modeling (NONMEM) system, the most powerful tool for pharmacokinetic / pharmacodynamic analysis. • Introduces requisite background to using Nonlinear Mixed Effects Modeling (NONMEM), covering data requirements, model building and evaluation, and quality control aspects • Provides examples of nonlinear modeling concepts and estimation basics with discussion on the model building process and applications of empirical Bayesian estimates in the drug development environment • Includes detailed chapters on data set structure, developing control streams for modeling and simulation, model applications, interpretation of NONMEM output and results, and quality control • Has datasets, programming code, and practice exercises with solutions, available on a supplementary website

Modern Approaches to Clinical Trials Using SAS Classical Adaptive and Bayesian Methods

Modern Approaches to Clinical Trials Using SAS  Classical  Adaptive  and Bayesian Methods Author Sandeep Menon
ISBN-10 9781629600826
Release 2015-12-09
Pages 364
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Get the tools you need to use SAS® in clinical trial design! Unique and multifaceted, Modern Approaches to Clinical Trials Using SAS: Classical, Adaptive, and Bayesian Methods, edited by Sandeep M. Menon and Richard C. Zink, thoroughly covers several domains of modern clinical trial design: classical, group sequential, adaptive, and Bayesian methods that are applicable to and widely used in various phases of pharmaceutical development. Written for biostatisticians, pharmacometricians, clinical developers, and statistical programmers involved in the design, analysis, and interpretation of clinical trials, as well as students in graduate and postgraduate programs in statistics or biostatistics, the book touches on a wide variety of topics, including dose-response and dose-escalation designs; sequential methods to stop trials early for overwhelming efficacy, safety, or futility; Bayesian designs that incorporate historical data; adaptive sample size re-estimation; adaptive randomization to allocate subjects to more effective treatments; and population enrichment designs. Methods are illustrated using clinical trials from diverse therapeutic areas, including dermatology, endocrinology, infectious disease, neurology, oncology, and rheumatology. Individual chapters are authored by renowned contributors, experts, and key opinion leaders from the pharmaceutical/medical device industry or academia. Numerous real-world examples and sample SAS code enable users to readily apply novel clinical trial design and analysis methodologies in practice.

Regression Modeling Strategies

Regression Modeling Strategies Author Frank Harrell
ISBN-10 9783319194257
Release 2015-08-14
Pages 582
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This highly anticipated second edition features new chapters and sections, 225 new references, and comprehensive R software. In keeping with the previous edition, this book is about the art and science of data analysis and predictive modeling, which entails choosing and using multiple tools. Instead of presenting isolated techniques, this text emphasizes problem solving strategies that address the many issues arising when developing multivariable models using real data and not standard textbook examples. It includes imputation methods for dealing with missing data effectively, methods for fitting nonlinear relationships and for making the estimation of transformations a formal part of the modeling process, methods for dealing with "too many variables to analyze and not enough observations," and powerful model validation techniques based on the bootstrap. The reader will gain a keen understanding of predictive accuracy and the harm of categorizing continuous predictors or outcomes. This text realistically deals with model uncertainty and its effects on inference, to achieve "safe data mining." It also presents many graphical methods for communicating complex regression models to non-statisticians. Regression Modeling Strategies presents full-scale case studies of non-trivial datasets instead of over-simplified illustrations of each method. These case studies use freely available R functions that make the multiple imputation, model building, validation and interpretation tasks described in the book relatively easy to do. Most of the methods in this text apply to all regression models, but special emphasis is given to multiple regression using generalized least squares for longitudinal data, the binary logistic model, models for ordinal responses, parametric survival regression models and the Cox semi parametric survival model. A new emphasis is given to the robust analysis of continuous dependent variables using ordinal regression. As in the first edition, this text is intended for Masters' or Ph.D. level graduate students who have had a general introductory probability and statistics course and who are well versed in ordinary multiple regression and intermediate algebra. The book will also serve as a reference for data analysts and statistical methodologists, as it contains an up-to-date survey and bibliography of modern statistical modeling techniques. Examples used in the text mostly come from biomedical research, but the methods are applicable anywhere predictive models ("analytics") are useful, including economics, epidemiology, sociology, psychology, engineering and marketing.

Biostatistics with R

Biostatistics with R Author Babak Shahbaba
ISBN-10 9781461413028
Release 2011-12-15
Pages 352
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Biostatistics with R is designed around the dynamic interplay among statistical methods, their applications in biology, and their implementation. The book explains basic statistical concepts with a simple yet rigorous language. The development of ideas is in the context of real applied problems, for which step-by-step instructions for using R and R-Commander are provided. Topics include data exploration, estimation, hypothesis testing, linear regression analysis, and clustering with two appendices on installing and using R and R-Commander. A novel feature of this book is an introduction to Bayesian analysis. This author discusses basic statistical analysis through a series of biological examples using R and R-Commander as computational tools. The book is ideal for instructors of basic statistics for biologists and other health scientists. The step-by-step application of statistical methods discussed in this book allows readers, who are interested in statistics and its application in biology, to use the book as a self-learning text.

Bayesian Designs for Phase I II Clinical Trials

Bayesian Designs for Phase I   II Clinical Trials Author Ying Yuan
ISBN-10 9781498709569
Release 2016-06-08
Pages 310
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Reliably optimizing a new treatment in humans is a critical first step in clinical evaluation since choosing a suboptimal dose or schedule may lead to failure in later trials. At the same time, if promising preclinical results do not translate into a real treatment advance, it is important to determine this quickly and terminate the clinical evaluation process to avoid wasting resources. Bayesian Designs for Phase I–II Clinical Trials describes how phase I–II designs can serve as a bridge or protective barrier between preclinical studies and large confirmatory clinical trials. It illustrates many of the severe drawbacks with conventional methods used for early-phase clinical trials and presents numerous Bayesian designs for human clinical trials of new experimental treatment regimes. The first two chapters minimize the technical language to make them accessible to non-statisticians. These chapters discuss the severe drawbacks of the conventional paradigm used for early-phase clinical trials and explain the phase I–II paradigm for optimizing dose, or more general treatment regimes, based on both efficacy and toxicity. The remainder of the book covers a wide variety of clinical trial methodologies, including designs to optimize the dose pair of a two-drug combination, jointly optimize dose and schedule, identify optimal personalized doses, optimize novel molecularly targeted agents, and choose doses in two treatment cycles. Written by research leaders from the University of Texas MD Anderson Cancer Center, this book shows how Bayesian designs for early-phase clinical trials can explore, refine, and optimize new experimental treatments. It emphasizes the importance of basing decisions on both efficacy and toxicity.