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      • Global Metabolic Profiling: Clinical Applications
        Analytical chemistry
        January 2014

        Global Metabolic Profiling: Clinical Applications

        by Ian D Wilson, Georgios Theodoridis, Andrew Nicholls

        The aim of many current global metabolic profiling studies is to discover and apply new metabolic biomarkers. These may be indicative of the mechanisms of disease or the propensity for it to develop, or may enable diagnosis, patient stratification, and prediction/monitoring of response to therapy. The use of global metabolic profiling in the clinic in the future seems assured, and it seems likely that future application will include novel innovations that will put metabolic profiling into the doctor’s consulting room or even into the hands of the surgeon in the operating theatre. The twelve chapters of this timely book provide a snapshot of the current state of the art in metabolic profiling in the clinic.

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      • Bioanalysis of Biotherapeutics
        Analytical chemistry
        October 2013

        Bioanalysis of Biotherapeutics

        by Boris Gorovits

        The pharmaceutical industry has recently introduced a number of biotherapeutics with alternative types of scaffolds and mechanisms of action. Concepts that were proposed several years or, in some cases, decades ago are starting to become a reality, with a number of new and exciting compounds achieving regulatory approval status. As the field evolves, appropriate bioanalytical applications must be developed and adapted. Highly sensitive, accurate and specific bioanalytical methods are now required to measure drug concentration and immunogenicity responses, and bioanalytical protocols must undergo formal validation prior to being applied in support of regulated nonclinical or clinical studies. The six chapters of this book introduce important and exciting challenges for the bioanalysis of peptides, oligonucleotides, antibody–drug conjugates and antibody-based compounds.

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      • Bioanalysis for Service Users
        Analytical chemistry
        October 2013

        Bioanalysis for Service Users

        by Anne-Francoise Aubry, Jim X Shen

        This book provides an important reference resource for users of bioanalytical services and will be helpful to nonexperts who need to interpret bioanalytical data or outsource bioanalytical assays. The eight chapters address many of the difficult issues and challenges in bioanalysis together with the capabilities, applications, advantages and limitations of the main technological platforms utilized. Validation principles and the experimental approaches used to establish validation parameters are explained, as well as the regulatory expectations regarding assay performance during routine sample analysis. Some guidance regarding outsourcing of bioanalytical assays and common assay performance issues and pitfalls is provided to help readers interact more knowledgeably with bioanalytical scientists and better follow investigations in the bioanalytical laboratory.

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      • Immunogenicity Assay Development, Validation and Implementation
        Analytical chemistry
        November 2013

        Immunogenicity Assay Development, Validation and Implementation

        by Robert Dodge, Renuka C Pillutla

        In recent years there have been significant improvements and standardization in immunogenicity testing and the reporting of results. Technology developments and responses to increasing regulatory expectations have enabled the development of superior bioanalytical methods. In nine chapters from international experts, this book provides an excellent overview, with detailed summaries of advances in testing schemes. Critical topics include reagents used in assays, a summary of techniques used in overcoming assay interferences and considerations in statistical evaluation. Overviews of neutralizing antibody assays are presented together with an overview of regulatory guidance and recommended procedures.

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      • Hot topics in Metabolomics: Food and Nutrition
        Analytical chemistry
        December 2013

        Hot topics in Metabolomics: Food and Nutrition

        by Bernd Markus Lange

        Metabolomics is an emerging technology aimed at providing comprehensive profiles of small-molecule metabolites accumulated in microbes, plants and animals, or in food products derived from these organisms. In this book, experts in the field have contributed eight chapters reviewing the current status of the use of metabolomics in the food and nutritional sciences. Three areas of research are addressed – first, integration of metabolomics into crop improvement programs based upon classical breeding or genetic engineering; second, the role of metabolomics in food quality control, including authentication, safety, predictive modeling of sensory and nutritional attributes, and the analysis of processed foods; finally, the utility of metabolomics in assessing the correlation of dietary composition and human health. Technological advances are continually increasing the utility of metabolomics, and food and nutritional enterprises have much to gain from integrating this technology across the different sectors.

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      • Eliminating Bottlenecks for Efficient Bioanalysis: Practices and Applications in Drug Discovery and Development
        Analytical chemistry
        October 2014

        Eliminating Bottlenecks for Efficient Bioanalysis: Practices and Applications in Drug Discovery and Development

        by Wilson Z Shou, Naidong Weng

        Bioanalysis, commonly defined as the quantitative analysis of drugs, metabolites and biomarkers in biological matrices, is an integral part of various activities within the entire drug discovery and development process. With the well-documented declining return on investment of R&D in the pharmaceutical industry, all areas of discovery and development are increasingly being asked to work individually and collectively to increase efficiency and boost productivity in bringing more innovative medicines to the market with flat, or even decreasing, development costs. The first six chapters of this book describe approaches and technologies to increase the speed and quality of bioanalysis, such as automated method development for sample preparation. Chapters 7–10 deal with some of these regulatory considerations in development bioanalysis. The remaining chapters of this book include a number of current and emerging applications that can have a profound impact on bioanalytical productivity due to their nonroutine nature.

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      • Applications of High-Resolution Mass Spectrometry in Drug Discovery and Development
        Analytical chemistry
        December 2013

        Applications of High-Resolution Mass Spectrometry in Drug Discovery and Development

        by Lekha Sleno

        High-resolution mass spectrometry (HRMS) has grown rapidly in recent years, with major breakthroughs in all areas of drug discovery and development. What started as a technique available to very few laboratories worldwide has become the most sought-after method for complex analyses. This book addresses key areas of bioanalytical mass spectrometry, from the elucidation of drug metabolites to quantifying biomolecules. The experts who have contributed the ten chapters of this eBook provide an invaluable overview of current and potential applications for HRMS in many facets of drug discovery and development.

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      • Microsampling in Pharmaceutical Bioanalysis
        Analytical chemistry
        December 2013

        Microsampling in Pharmaceutical Bioanalysis

        by Patricia Zane & Gary T Emmons

        Blood microsampling techniques, such as dried blood spot (DBS), capillary microsampling and microdialysis, offer many advantages compared with traditional liquid blood or plasma sampling. The nine chapters of this book present the state of the art for the various microsampling techniques currently available, along with the analytical techniques and challenges associated with them. The whole process is considered, from sample collection in the clinic, to bioanalysis and then interpretation of data from microsamples by the end user (pharmacokineticists, toxicologists and clinicians), together with current regulatory implications. The book also includes case studies where these techniques have been used successfully with the understanding that no innovation is without its honorable failures. Finally, the book addresses future developments, both technical and general, and how these technologies will continue to grow and find applications.

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      • Identification and Data Processing Methods in Metabolomics
        Analytical chemistry
        September 2014

        Identification and Data Processing Methods in Metabolomics

        by Serge Rudaz

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      • Advances in Liquid Chromatography: New Developments in Stationary Phases and Supports for Drugs and Bioanalytical Applications
        Analytical chemistry
        October 2015

        Advances in Liquid Chromatography: New Developments in Stationary Phases and Supports for Drugs and Bioanalytical Applications

        by David Hage

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      • Novel Methods in Bioanalysis and Characterization of Antibody–Drug Conjugates
        Analytical chemistry
        April 2014

        Novel Methods in Bioanalysis and Characterization of Antibody–Drug Conjugates

        by Boris Gorovits & Stacy Shord

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      • Novel Methods in Bioanalysis and Characterization of Antibody–Drug Conjugates
        Analytical chemistry
        April 2014

        Novel Methods in Bioanalysis and Characterization of Antibody–Drug Conjugates

        by Boris Gorovits & Stacy Shord

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