Search results for ""Author Harry Yang""
Taylor & Francis Inc 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.
£94.99
Taylor & Francis Ltd Real-World Evidence in Drug Development and Evaluation
Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering the latest development in the field.Written specifically for pharmaceutical practitioners, Real-World Evidence in Drug Development and Evaluation, presents a wide range of RWE applications throughout the lifecycle of drug product development. With contributions from experienced researchers in the pharmaceutical industry, the book discusses at length RWE opportunities, challenges, and solutions.Features Provides the first book and a single source of information on RWE in drug development Covers a broad array of topics on outcomes- and value-based RWE assessments Demonstrates proper Bayesian application and causal inference for real-world data (RWD) Presents real-world use cases to illustrate the use of advanced analytics and statistical methods to generate insights Offers a balanced discussion of practical RWE issues at hand and technical solutions suitable for practitioners with limited data science expertise
£115.00
Taylor & Francis Inc Statistical Methods in Drug Combination Studies
The growing interest in using combination drugs to treat various complex diseases has spawned the development of many novel statistical methodologies. The theoretical development, coupled with advances in statistical computing, makes it possible to apply these emerging statistical methods in in vitro and in vivo drug combination assessments. However, despite these advances, no book has served as a single source of information for statistical methods in drug combination research, nor has there been any guidance for experimental strategies.Statistical Methods in Drug Combination Studies fills that gap, covering 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 comprehensive reference: Describes statistical models used to characterize dose–response patterns of monotherapies and evaluate the combination drug synergy Offers guidance for estimating interaction indices and constructing their associated confidence intervals to assess drug interaction Introduces a practical and innovative Bayesian approach to Phase I cancer trials, including actual trial examples to illustrate use Examines strategies in the fixed-dose combination therapy clinical development via case studies stemming from regulatory reviews Evaluates computational tools and software packages used to apply novel statistical methods in combination drug development Statistical Methods in Drug Combination Studies provides researchers with a solid understanding of the available statistical methods and computational tools and how to apply them in drug combination studies. The book is equally useful for statisticians to become better equipped to deal with drug combination study design and analysis in their practice.
£130.00
