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Toxicity-Pathway-Based Risk Assessment
In 2007, the National Research Council envisioned a new paradigm in which biologically important perturbations in key toxicity pathways would be evaluated with new methods in molecular biology, bioinformatics, computational toxicology, and a comprehensive array of in vitro tests based primarily on human biology. Although some considered the vision too optimistic with respect to the promise of the new science, no one can deny that a revolution in toxicity testing is under way. New approaches are being developed, and data are being generated. As a result, the U.S. Environmental Protection Agency (EPA) expects a large influx of data that will need to be evaluated. EPA also is faced with tens of...
Accelerating the Development of Biomarkers for Drug Safety
Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development. On October 24, 2008, the IOM's Forum on Drug Discovery, Development, and Translation held "Assessing and Accelerating Development of Biomarkers for Drug Safety," a one-day workshop, summarized in this volume, on the value of biomarkers in helping to determine drug safety during development.
Biomarkers in Drug Development
Discover how biomarkers can boost the success rate of drug development efforts As pharmaceutical companies struggle to improve the success rate and cost-effectiveness of the drug development process, biomarkers have emerged as a valuable tool. This book synthesizes and reviews the latest efforts to identify, develop, and integrate biomarkers as a key strategy in translational medicine and the drug development process. Filled with case studies, the book demonstrates how biomarkers can improve drug development timelines, lower costs, facilitate better compound selection, reduce late-stage attrition, and open the door to personalized medicine. Biomarkers in Drug Development is divided into eigh...
New Horizons in Predictive Toxicology
The sophistication of modelling and simulation technologies have improved dramatically over the past decade and their applications in toxicity prediction and risk assessment are of critical importance. The integration of predictive toxicology approaches will become increasingly necessary as industrial chemicals advance and as new pharmaceuticals enter the market. In this comprehensive discussion of predictive toxicology and its applications, leading experts express their views on the technologies currently available and the potential for future developments. The book covers a wide range of topics including in silico, in vitro and in vivo approaches that are being used in the safety assessmen...
Membrane Trafficking
As membrane trafficking research has expanded over the past thirty years, a remarkable convergence of information has been gained by using genetic approaches in yeast cells with biochemical approaches in mammalian cells. This book reflects these advances by devoting one section of the book to yeast cells and the other to mammalian cells, with each section providing both classic and cutting-edge techniques to study macromolecular transport across the membranes.
Validation of Toxicogenomic Technologies
Beginning in the early 1980s, new technologies, began to permit evaluation of the expression of individual genes. Recent technological advances have expanded those evaluations to permit the simultaneous detection of the expression of tens of thousands of genes and to support holistic evaluations of the entire genome. The application of these technologies has enabled researchers to unravel complexities of cell biology and, in conjunction with toxicologic evaluations, the technologies are used to probe and gain insight into questions of toxicologic relevance. As a result, the use of the technologies has become increasingly important for scientists in academia, as well as for the regulatory and drug development process.
Genetic Polymorphisms and Susceptibility to Disease
Genetic Polymorphisms and Susceptibity to Disease provides a reference for established researchers in genetic research. The book provides a broad but thorough overview of how allelic gene differences influence disease susceptibility in the human population, and will be a useful reference to researchers across a range of disciplines, for example, oncology, cardiology and immunology . In addition, this book serves as a primer for students first entering the field of genetic research.
Nanostructure Design
As one of the fastest growing fields of research in the 21st century, nanotechnology is sure to have an enormous impact on many aspects of our lives. Nanostructure Design: Methods and Protocols serves as a major reference for theoretical and experimental considerations in the design of biological and bio-inspired building blocks, the physical characterization of the formed structures, and the development of their technical applications. The chapters contributed by leading experts are divided into two sections, the first of which covers experimental aspects of nanostructure design and the second delves into computational methods. As a volume of the highly successful Methods in Molecular BiologyTM series, this collection pulls together cutting-edge protocols, written in a step-by-step, readily reproducible format certain to guide researchers to the desired results. Comprehensive and essential, Nanostructure Design: Methods and Protocols uses biological principles and vehicles on design to aid scientists in the great challenges still ahead.
PCR Protocols in Molecular Toxicology
Molecular toxicology is an emerging discipline that utilizes molecular and cell biology to understand how drugs and chemicals result in their unwanted effects. PCR Protocols in Molecular Toxicology is a practical guide to the use of polymerase chain reaction (PCR) to help examine, on a molecular and cellular level, how toxic responses are manifested. It offers a basic understanding of PCR and its optimization, as well as describing specific, high-impact areas of molecular toxicology and recent advances. The following techniques are described in detail: Quantitative reverse transcriptase PCR and methods to examine gene expression Differential display cloning Cloning and library screening by PCR Genotype and polymorphism analysis of drug and toxicant metabolizing enzymes Basic, non-PCR based molecular biology methods PCR Protocols in Molecular Toxicology will aid both novices and experienced PCR practitioners in using PCR to its fullest potential.
