Biomarkers in medicine
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Biomarkers in medicine · Jun 2010
ReviewClinical application of sensitive cardiac troponin assays: potential and limitations.
Acute myocardial infarction (AMI) is the major cause of death worldwide. Cardiac troponins (cTns) are structural proteins, unique to the heart, that currently form the cornerstone of the AMI diagnosis. The major limitation of standard cTn assays is a sensitivity deficit at presentation caused by a delayed increase of circulating levels. ⋯ The differential diagnosis of a small amount of myocardial injury and, therefore, mild elevation of cTn is broad, and includes acute and chronic disorders. The differential diagnosis of a large amount of myocardial injury and, therefore, substantial elevation of cTn is much smaller and largely restricted to AMI, myocarditis and takotsubo cardiomyopathy. The aim of this article is to guide clinicians in the use of sensitive cTn.
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Biomarkers in medicine · Apr 2010
ReviewNeutrophil gelatinase-associated lipocalin: a promising biomarker for human acute kidney injury.
Acute kidney injury (AKI) is a common and serious condition, the diagnosis of which depends on serum creatinine measurements. Unfortunately, creatinine is a delayed and unreliable indicator of AKI. ⋯ The discovery, translation and validation of neutrophil gelatinase-associated lipocalin, arguably the most promising novel AKI biomarker, are reviewed in this article. Neutrophil gelatinase-associated lipocalin is emerging as an excellent standalone troponin-like biomarker in the plasma and urine for the prediction of AKI, monitoring clinical trials in AKI and for the prognosis of AKI in several common clinical scenarios.
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Biomarkers in medicine · Dec 2009
Interview with Janet Woodcock: progress on the FDA's critical path initiative.
Janet Woodcock is the Director of the US FDA's Center for Drug Evaluation and Research. Dr Woodcock has held various positions within the FDA's Office of the Commissioner from October 2003 until 1 April, 2008, as Deputy Commissioner and Chief Medical Officer, Deputy Commissioner for Operations and Chief Operating Officer and Director of the Critical Path Programs. She oversaw scientific and medical regulatory operations for the FDA. ⋯ She previously served in other positions at the FDA including Director of the Office of Therapeutics Research and Review and Acting Deputy Director of the Center for Biologics Evaluation and Research. Dr Woodcock received her MD from Northwestern Medical School (IL, USA), and completed further training and held teaching appointments at the Pennsylvania State University (PA, USA)and the University of California in San Francisco (CA, USA). She joined the FDA in 1986.
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Individualized medicine provides a powerful engine revolutionizing the practice of clinical pharmacology, tailoring genetic and molecular profiles of patients to improve therapeutic specificity, reduce treatment variability and minimize adverse drug events. In that context, advances in individualized medicine have transformed the science of clinical pharmacology and therapeutics from drug discovery through identification of drugable targets, development through stratification of disease risk, regulation through identifying pathways mediating off-target effects and utilization through personalizing drug regimens. ⋯ Insights in the mechanistic basis of cell, tissue and organ function, and their interface with the environment are being translated to define disease risk, identify processes mediating disease susceptibility, target mechanism-based therapies, and tailor prevention and control paradigms, providing previously unanticipated opportunities for patient-specific disease management. The emerging field of individualized medicine is transforming the practice of clinical pharmacology, driving the leading edge of discovery from the laboratory bench to the evidence basis of practice in the clinic, extending to populations, to transform healthcare and create predictive, personalized and pre-emptive solutions for tailored patient-specific therapeutic strategies.
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Biomarkers in medicine · Apr 2009
Theme: neurology--optic nerve sheath diameter measurement as a risk marker for significant intracranial hypertension.
Raised intracranial pressure (ICP) is a frequent condition in many medical and surgical situations and is often difficult to detect. Noninvasive estimates of raised ICP are of interest to allow rapid detection of significant intracranial hypertension. In the anterior part of the optic nerve, the sheath is distensible and can inflate in the case of raised pressure in the cerebrospinal fluid. ⋯ Ocular sonography is simple, rapid, noninvasive and can be performed at the patient's bedside, but it requires training and experience. The cut-off value for ICP greater than 20 mmHg is 5.8 mm, with a 90% probability of correct diagnosis. When raised ICP is suspected, but invasive ICP monitoring cannot be used or is not clearly recommended, this estimation of the risk of raised ICP may be of great clinical value, aiding in the detection of patients at risk of raised ICP.