Bøger i Chapman & Hall/CRC Biostatistics Series serien

This book provides the first comprehensive account of the self-controlled case series (SCCS) method, a statistical method for investigating associations between outcome events and time-varying exposures.

Clinical trials require strategic thinking and innovative methods since some traditional methods are not adequate for the 21st century.To solve these problems requires good methodological skills, but also an in-depth knowledge of the practical problems we are dealing with and a strategic vision of the pig picture.

Methodologies in Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product.

This comprehensive reference covers all aspects of drug combination research, from designing in vitro drug combination studies to analyzing clinical trial data. Featuring contributions from researchers in industry, academia, and regulatory agencies, this balanced text provides researchers with a solid understanding of the available statis

This book offers 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. The book explains how to identify molecular biomarkers using DNA microarrays, validate the developed biomarkers, and confirm

This practical and thorough book explains when and how to use models and techniques for the analysis of competing risks and intermediate states. It covers the most recent insights on estimation techniques and discusses in detail how to interpret the obtained results. Each chapter includes standard exercises; a software section on SAS, Stata, and

This book explores a wide range of topics in exposure-response modeling, from traditional PKPD modeling to other areas in drug development and beyond. It incorporates numerous examples and software programs for implementing novel methods. The book emphasizes dose adjustment and treatment adaptation based on dynamic exposure-response models, illu

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. Along with covering regulatory requirements, the authors discuss statisti

This book presents statistical models and methods for the analysis of longitudinal data. It focuses on models for analyzing repeated measures of quantitative and qualitative variables and events history, including survival and multistate models. The book also explores the possibility of unifying these models through a stochastic process point of

This guide explains how to apply health economic evaluation techniques to both clinical trial and non-clinical trial data. Through a simple, applied approach using examples and SAS software, the book helps statisticians and researchers in health economics assess cost-effectiveness. It covers trial design, case report form design, quality of life

This book presents a comprehensive overview on the current status of conducting MRCTs in clinical development. It first provides a high-level introduction to the context, motivation, opportunities, and challenges in simultaneous global clinical development using MRCTs. It then focuses on the design, monitoring, and analysis/interpretation of MRC

This book provides guidance on selecting specific benefit-risk (B-R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B-R assessment in clinical development and regulatory submission. The

This book shows how to apply biclustering methods to find local patterns in a big data matrix. It 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. All

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 compreh

Missing data in longitudinal clinical trials has justifiably been the target of considerable research. However, missing data is just one of the many considerations in the analysis of longitudinal data, and focus on the data we don't have should not distract from focus on the data we do have. The statistical theory relevant to analyses of longitu

When a true endpoint is difficult to use because of such factors as long follow-up times or prohibitive cost, it is sometimes possible to use a surrogate endpoint that can be measured in a more convenient or cost-effective way. This book focuses on the use of surrogate endpoint evaluation methods in practice, using SAS and R.

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

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 statisti

This book provides the application of generalized linear mixed-effects models and its related models in the statistical design and analysis of repeated measures adopted in randomized controlled trials. With increasing concerns about intra-patient variability of treatment effects, the traditional ANCOVA-type methods can no longer cope with these

This book deals with randomization in clinical trials. Currently trials use permuted blocks randomization almost exclusively. Many researchers are aware of the drawbacks to this fatally flawed method, and while many are unaware of any better randomization methods, in fact several groups have proposed improvements, and also demonstrated the benef

This book focuses on clinical trial design and monitoring with time-to-event endpoints. Detail of subjects of the book are included in book contents. This book not only provides a comprehensive review of existing methods. The book also presents a general group sequential method for trial monitoring which has not been published in any book.

Drug development sponsors cannot run individual trials for all products in all indications. This results in missed opportunities. Clinical trial programs known as "basket" and "umbrella" have demonstrated that multi-product, multi-indication trials can be efficient and feasible.

Focuses on full analyses of real data sets based on the needs and requirements of end users. Fundamental theory is introduced with emphasis on the motivation by challenges coming from real problems with real data. Complete explanations of important concepts are provided, but the amount of mathematical derivation of formulation is minimized.

Employs a Bayesian approach to provide statistical inferences based on various models of intra- and inter rater agreement. This book explores numerous measures of agreement, including the Kappa coefficient, the G coefficient, and intraclass correlation. It discusses how to successfully design and analyze an agreement study.

This book will present a unified and up-to date introduction to ROC methodologies, covering both diagnosis (classification) and prediction. The book will emphasize the practical implementation of these methods using standard statistical software such as R and STATA.

This book presents the advanced statistical methods for mapping pharmacogenetic control by integrating pharmacokinetic and pharmacodynamic principles of drug-body interactions. This book is suitable for graduate students and researchers in the field of biology, medicine, bioinformatics and drug design and delivery.