Bioanalysis
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For the last few decades intense scientific research has been placed on the relationship between trace substances found in exhaled breath such as volatile organic compounds (VOC) and a wide range of local or systemic diseases. Although currently there is no general consensus, results imply that VOC have a different profile depending on the organ or disease that generates them. ⋯ The present review describes the current advances in identifying and quantifying VOC used as biomarkers for a number of systemic diseases. A special focus will be placed on volatiles that characterize unpleasant breath 'fingerprints' such as fetor hepaticus; uremic fetor; fetor ex ore or trimethylaminuria.
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With the advent of novel technologies, considerable advances have been made in the evaluation of the relationship between PK and PD. Ligand-binding assays have been the primary assay format supporting PK and immunogenicity assessments. ⋯ This review illustrates key challenges with regard to understanding the relationship between anti-drug antibody and PK/PD, including confounding factors associated with the development and validation of ligand-binding assays, mechanisms by which anti-drug antibody impacts PK/PD, factors to consider during data analyses and interpretation, and a perspective on integrating immunogenicity data into the well-established quantitative modeling approach. Through recognizing these challenges, we propose some opportunities for improvements in the development and validation of fit-for-purpose bioanalytical methods.
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In-community non-invasive identification of asthma-specific volatile organic compounds (VOCs) in exhaled breath presents opportunities to characterize phenotypes, and monitor disease state and therapies. The feasibility of breath sampling with children and the preliminary identification of childhood asthma markers were studied. ⋯ This method was found to be acceptable for children, and healthy and asthmatic individuals were distinguished on the basis of eight VOCs at elevated levels in the breath of asthmatic children.
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This year has so far proven to be another eventful one for the journal and its affiliated website Bioanalysis Zone. Key highlights include the unveiling of the finalists for the annual Young Investigator Award [1] , the publication of four exciting special issues and a selection of noteworthy White Papers, as well as the addition of more new features on Bioanalysis Zone. ⋯ This mid-year round-up looks at the highlights of the year to date and features a selection of must-read articles from volume 5. Enjoy!
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The revolution in disease diagnosis and treatment promised on the completion of the human genome project over a decade ago has materialized in the form of unified drug and biomarker discovery and development pipelines. This strategic shift has been principally catalyzed through success stories in the field of oncology, ushering in the era of personalized medicine. ⋯ Perhaps more importantly, however, the late adoption of biomarker strategies has also rescued drug candidates from complete late-stage failure. This review examines the historical lessons of key challenges in translating biomarker assay information into strategic and clinically actionable decisions and assesses the impact of personalized genome sequencing in the future of companion diagnostic development and commercialization.