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Biosimilar Clinical Development: Scientific Considerations and New Methodologies
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.
Essentials of a Successful Biostatistical Collaboration
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.
The Palgrave Handbook on the Economics of Manipulation in Sport
Sport has enjoyed steadily increasing prominence and economic importance since the Millennium. But threats to its integrity appear to have grown in parallel, undermining the very sense of innocence and fun which is an important part of its appeal. Threats to the spirit of sport come from internal, external and even state actors, who seek either to manipulate events on the field or to exploit the institutions of sport for their own ends. As the reputation of sport becomes more tarnished as a result, its sustainability as a significant part of the entertainment industry is called into question and loss of reputation may even result in decline in recreational play. In this wide-ranging collecti...
Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing
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.
Medical Biostatistics
Encyclopedic in breadth, yet practical and concise, Medical Biostatistics, Fourth Edition focuses on the statistical aspects ofmedicine with a medical perspective, showing the utility of biostatistics as a tool to manage many medical uncertainties. This edition includes more topics in order to fill gaps in the previous edition. Various topics have been enlarged and modified as per the new understanding of the subject.
Analyzing Longitudinal Clinical Trial Data
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.
Routledge Handbook of Sports Marketing
Sports marketing has become a cornerstone of successful sports management and business, driving growth in sport organisations and widening fan-bases. Showcasing the latest thinking and research in sports marketing from around the world, the Routledge Handbook of Sports Marketing goes further than any other book in exploring the full range of this exciting discipline. Featuring contributions from world-leading scholars and practitioners from across the globe, the book examines theories, concepts, issues and best practice across six thematic sections—brands, sponsorship, ambush marketing, fans and spectators, media, and ethics and development—and examines key topics such as: consumer behaviour marketing communications strategic marketing international marketing experiential marketing and marketing and digital media Comprehensive and authoritative, the Routledge Handbook of Sports Marketing is an essential reference for any student or researcher working in sport marketing, sport management, sport business, sports administration or sport development, and for all practitioners looking to develop their professional knowledge.
