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Examines Critical Decisions for Transitioning Lab Science to a Clinical SettingThe development of therapeutic pharmaceutical compounds is becoming more expensive, and the success rates for getting such treatments approved for marketing and to the patients is decreasing. As a result, translational medicine (TM) is becoming increasingly important in
Providing an interface between dry-bench bioinformaticians and wet-lab biologists, DNA Methylation Microarrays: Experimental Design and Statistical Analysis presents the statistical methods and tools to analyze high-throughput epigenomic data, in particular, DNA methylation microarray data. Since these microarrays share the same under
The concept of frailty offers a convenient way to introduce unobserved heterogeneity and associations into models for survival data. In its simplest form, frailty is an unobserved random proportionality factor that modifies the hazard function of an individual or a group of related individuals. Frailty Models in Survival Analysis presents a comprehensive overview of the fundamental approaches in the area of frailty models. The book extensively explores how univariate frailty models can represent unobserved heterogeneity. It also emphasizes correlated frailty models as extensions of univariate and shared frailty models. The author analyzes similarities and differences between frailty and copu...
Carefully designed for use by clinical and pharmaceutical researchers and scientists, Handbook of Regression Analysis and Modeling explores statistical methods that have been adapted into biological applications for the quickly evolving field of biostatistics. The author clearly delineates a six-step method for hypothesis testing using data that mi
Continuing advances in biomedical research and statistical methods call for a constant stream of updated, cohesive accounts of new developments so that the methodologies can be properly implemented in the biomedical field. Responding to this need, Computational Methods in Biomedical Research explores important current and emerging computational statistical methods that are used in biomedical research. Written by active researchers in the field, this authoritative collection covers a wide range of topics. It introduces each topic at a basic level, before moving on to more advanced discussions of applications. The book begins with microarray data analysis, machine learning techniques, and mass...
The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how sta
Emphasizing statistical concepts used in medicine, the interpretation of methods, and applications, Medical Biostatistics, Second Edition shows how biostatistical methods are important tools in managing uncertainties in medicine and the health sciences. With coverage ranging from elementary topics, such as mean and standard deviation, to adv
Being that pharmacokinetics (PK) is the study of how the body handles various substances, it is not surprising that PK plays an important role in the early development of new drugs. However, the clinical research community widely believes that mathematics in some way blurs the true meaning of PK. Demonstrating that quite the opposite is true, Computational Pharmacokinetics outlines the fundamental concepts and models of PK from a mathematical perspective based on clinically relevant parameters. After an introductory chapter, the book presents a noncompartmental approach to PK and discusses the numerical analysis of PK data, including a description of an absorption process through numerical d...
Although adaptive design methods are flexible and useful in clinical research, little or no regulatory guidelines are available. One of the first books on the topic, Adaptive Design Methods in Clinical Trials presents the principles and methodologies in adaptive design and analysis that pertain to adaptations made to trial or statistical procedures