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Benefit-Risk Assessment In Pharmaceutical Research And Development

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Benefit-Risk Assessment In Pharmaceutical Research And Development

67,56€ + 10% CARD

 Many practitioners in the pharmaceutical industry are still largely unfamiliar with benefit-risk assessment, despite its growing prominence in drug development and commercialization. Helping to alleviate this knowledge gap, Benefit-Risk Assessment in Pharmaceutical Research and Development provides a succinct overview of the key considerations relevant to benefit-risk assessment across the pharmaceutical R&D spectrum, from early clinical development to late-stage development to regulatory review to post-launch assessment.The book first presents interpretations of benefit and risk in the context of a molecule moving from preclinical evaluation into its early testing in humans. It next considers benefit and risk characterization and assessment during a molecule's journey from its clinical evaluation in humans through its submission to regulators for marketing approval. Throughout these sections, the book offers insight into the role of benefit-risk assessment in heightening understanding among key stakeholders by shaping questions and guiding discussions among scientists, physicians, developers, and regulatory agencies. The book also focuses on a molecule's entry into the marketplace as a drug available for consumption by people. It explores the role of benefit-risk assessment as the relevance of carefully collected clinical efficacy and safety metrics fades in the wake of real-world use and evidence of effectiveness and safety.Bringing together the expertise of 15 contributors from academia and the industry, this book offers an easy-to-read guide to the various facets of benefit-risk assessment in the major stages of pharmaceutical R&D. Suitable for those in both technical and managerial roles, it enables readers to communicate more effectively across their development chain as well as rationally and thoughtfully embed benefit-risk assessment into their R&D processes.
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Multiple Testing Problems In Pharmaceutical Statistics

64,91€ + 10% CARD

 Explains how to solve important problems in multiple testing encountered in drug discovery, pre-clinical, and clinical trial applications. This book presents relevant statistical methodology; illustrates the methodology using real-life examples from drug discovery experiments; and provides software code for solving the problems.
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Patient-Reported Outcomes - Measurement, Implementation And Interpretation

by Andrew G. Bushmakin, Demissie Alemayehu, Jose Ma. J. Alvir, Joseph C. Cappelleri, Kelly H. Zou e Tara Symonds

72,86€ + 10% CARD

 However, exciting new developments are on the verge of changing the treatment of this debilitating disorder. Two anabolic agents, the parathyroid hormone (PTH) and the fluoride ion, show tremendous promise as tools for building and retaining bone - with no adverse side effects. Anabolic Treatments for Osteoporosis is a comprehensive account of the latest studies that have been carried out on these two agents, and a thorough assessment of their prospects as osteoporosis therapeutics. This unique book combines basic science and up-to-date clinical data to present a complete picture of this breakthrough in the treatment of a globally significant health issue.
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Statistical Methods For Drug Safety

by Anup Amatya e Robert D. Gibbons

64,91€ + 10% CARD

 Explore Important Tools for High-Quality Work in Pharmaceutical SafetyStatistical Methods for Drug Safety presents a wide variety of statistical approaches for analyzing pharmacoepidemiologic data. It covers both commonly used techniques, such as proportional reporting ratios for the analysis of spontaneous adverse event reports, and newer approaches, such as the use of marginal structural models for controlling dynamic selection bias in the analysis of large-scale longitudinal observational data.Choose the Right Statistical Approach for Analyzing Your Drug Safety DataThe book describes linear and non-linear mixed-effects models, discrete-time survival models, and new approaches to the meta-analysis of rare binary adverse events. It explores research involving the re-analysis of complete longitudinal patient records from randomized clinical trials. The book discusses causal inference models, including propensity score matching, marginal structural models, and differential effects, as well as mixed-effects Poisson regression models for analyzing ecological data, such as county-level adverse event rates. The authors also cover numerous other methods useful for the analysis of within-subject and between-subject variation in adverse events abstracted from large-scale medical claims databases, electronic health records, and additional observational data streams. Advance Statistical Practice in PharmacoepidemiologyAuthored by two professors at the forefront of developing new statistical methodologies to address pharmacoepidemiologic problems, this book provides a cohesive compendium of statistical methods that pharmacoepidemiologists can readily use in their work. It also encourages statistical scientists to develop new methods that go beyond the foundation covered in the text.
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Bayesian Models In Health Technology Assessment

by Gianluca (Department Of Statistical Science, University College London, Uk) Baio

~~124,36€~~ 87,05€ 30% OFF

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 Aims at presented a thorough and yet accessible description of the philosophy underlying the Bayesian approach to statistical inference, as specifically applied to the process of health technology assessment (HTA). The book is grounded in practical examples.
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Does This Treatment Cause That Outcome? - The Science Of Estimating A Treatment Effect And Why It Matters

by Stephen J. Ruberg

~~77,05€~~ 53,94€ 30% OFF

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 Does This Treatment Cause That Outcome?: The Science of Estimating a Treatment Effect and Why It Matters is an engaging and insightful exploration of cause-and-effect relationships in clinical research. It begins with the foundational principles of causal inference, traces the historical evolution of randomized controlled trials.
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Does This Treatment Cause That Outcome? - The Science Of Estimating A Treatment Effect And Why It Matters

by Stephen J. Ruberg

~~202,78€~~ 141,95€ 30% OFF

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 Does This Treatment Cause That Outcome?: The Science of Estimating a Treatment Effect and Why It Matters is an engaging and insightful exploration of cause-and-effect relationships in clinical research. It begins with the foundational principles of causal inference, traces the historical evolution of randomized controlled trials.
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Biostatistics For Bioassay

by Ann Yellowlees e Matthew Stephenson

~~75,69€~~ 52,98€ 30% OFF

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 This book is about the statistical analysis techniques that are needed in order to report the results of biological assays. These assays are needed for testing all biological medicines, such as vaccines and cell therapies, to allow them to be released for use.
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Master Protocol Clinical Trials For Evidence Generation - Strategies, Designs, Operations, And Case Studies

~~70,29€~~ 49,20€ 30% OFF

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 This book provides a multidisciplinary exploration of master protocol clinical trials, blending clinical, statistical, regulatory, operational, economic insights and patients perspectives. It examines both opportunities and challenges in design and implementation, and provides in-depth summary and discussion on real-world examples.
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Master Protocol Clinical Trials For Evidence Generation - Strategies, Designs, Operations, And Case Studies

~~189,26€~~ 132,48€ 30% OFF

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 This book provides a multidisciplinary exploration of master protocol clinical trials, blending clinical, statistical, regulatory, operational, economic insights and patients perspectives. It examines both opportunities and challenges in design and implementation, and provides in-depth summary and discussion on real-world examples.
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Comparative Effectiveness And Personalized Medicine Research Using Real-World Data

~~254,14€~~ 177,90€ 30% OFF

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 Pivotal to influencing regulatory policies (e.g.,authorization of new drugs), economic evaluations (e.g., reimbursement decisions), and the standardization of care across diverse settings (e.g., through the development of treatment guidelines) for well-functioning healthcare systems.
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Dose-Exposure-Response Modeling - Methods And Practical Implementation

by Jixian (Celgene International, Switzerland) Wang

~~168,97€~~ 118,28€ 30% OFF

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 This thoroughly revised and updated new edition reflects the progress that has been made in dose-exposure-response (DER) modelling. As the title suggests, the new edition covers more topics on dose and dose adjustment. A large part of the book has been rewritten.
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Machine Learning For Microbiome Statistics

by Jun (Department Of Medicine, University Of Illinois Chicago, Usa) Sun e Yinglin Xia

~~232,51€~~ 162,76€ 30% OFF

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 This unique book aims to address the challenges of machine learning statistics, emphasize the importance of performance valuation by appropriate metrics and independent data, and describe several important concepts of machine learning statistics, such as feature engineering and overfitting.
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Power And Sample Size In R

by Catherine M. Crespi

~~74,19€~~ 66,77€ 10% OFF

 This book guides the reader through power and sample size calculations for a variety of study outcomes and designs and illustrates their implementation in R. It is designed to be used as a learning tool for students as well as a resource for experienced statisticians and investigators.
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Power And Sample Size In R

by Catherine M. Crespi

~~74,19€~~ 66,77€ 10% OFF

 This book guides the reader through power and sample size calculations for a variety of study outcomes and designs and illustrates their implementation in R. It is designed to be used as a learning tool for students as well as a resource for experienced statisticians and investigators.
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Clinical Trial Modernization - Technological, Operational, And Regulatory Advances

by Harry Yang e Liang Zhao

~~74,19€~~ 66,77€ 10% OFF

 This book provides a comprehensive overview of the current trends, challenges, and opportunities in modernizing clinical trials, offering a roadmap for stakeholders in this evolving field. It provides actionable insights into the future of clinical trials and their role in bringing new therapies to market faster and more effectively.
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Clinical Trial Modernization - Technological, Operational, And Regulatory Advances

by Harry Yang e Liang Zhao

~~74,19€~~ 66,77€ 10% OFF

 This book provides a comprehensive overview of the current trends, challenges, and opportunities in modernizing clinical trials, offering a roadmap for stakeholders in this evolving field. It provides actionable insights into the future of clinical trials and their role in bringing new therapies to market faster and more effectively.
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Cluster Randomization Trials - Statistical Design And Analysis

by Sin-Ho Jung

~~74,19€~~ 66,77€ 10% OFF

 This books covers all three types of trials resulting in clustered data. For outcome variables of binary, continuous, and time to event types. The methods are discussed in terms of clinical trials, but can be used to design and analyze any types of experiments involving clustered data.
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Cluster Randomization Trials - Statistical Design And Analysis

by Sin-Ho Jung

~~74,19€~~ 66,77€ 10% OFF

 This books covers all three types of trials resulting in clustered data. For outcome variables of binary, continuous, and time to event types. The methods are discussed in terms of clinical trials, but can be used to design and analyze any types of experiments involving clustered data.
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Bayesian Methods In Epidemiology

by Lyle D. Broemeling

67,56€ + 10% CARD

 Written by a biostatistics expert with over 20 years of experience in the field, Bayesian Methods in Epidemiology presents statistical methods used in epidemiology from a Bayesian viewpoint. It employs the software package WinBUGS to carry out the analyses and offers the code in the text and for download online.The book examines study designs that
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Design And Analysis Of Clinical Trials For Predictive Medicine

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Design And Analysis Of Clinical Trials For Predictive Medicine

70,21€ + 10% CARD

 Design and Analysis of Clinical Trials for Predictive Medicine provides statistical guidance on conducting clinical trials for predictive medicine. It covers statistical topics relevant to the main clinical research phases for developing molecular diagnostics and therapeutics-from identifying molecular biomarkers using DNA microarrays to confirming
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Generalized Linear Models - A Bayesian Perspective

90,09€ + 10% CARD

 Describes how to conceptualize, perform, and critique traditional generalized linear models (GLMs) from a Bayesian perspective and how to use modern computational methods to summarize inferences using simulation. Introducing dynamic modeling for GLMs, this work considers parametric and semiparametric approaches to overdispersed GLMs.
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Design And Analysis Of Animal Studies In Pharmaceutical Development

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Design And Analysis Of Animal Studies In Pharmaceutical Development

67,56€ + 10% CARD

 "Provides well-integrated, comprehensive coverage of all the major statistical designs and methods used for animal studies in pharmaceutical research and development. Demonstrates the correct way to interpret the results of animal studies in the risk assessment of biopharmaceutical products and clarifies detailed presentations with real-world examp
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Multiregional Clinical Trials For Simultaneous Global New Drug Development

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Multiregional Clinical Trials For Simultaneous Global New Drug Development

68,89€ + 10% CARD

 In a global clinical development strategy, multiregional clinical trials (MRCTs) are vital in the development of innovative medicines. Multiregional Clinical Trials for Simultaneous Global New Drug Development presents a comprehensive overview on the current status of conducting MRCTs in clinical development. International experts from academia, in
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