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Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium

Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium

http://www.wikidata.org/entity/Q58071225

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Lost in Translation (LiT): IUPHAR Review 6 Kidney Injury Molecule-1 and Cardiovascular Diseases: From Basic Science to Clinical Practice microRNAs as pharmacogenomic biomarkers for drug efficacy and drug safety assessment Megalin in acute kidney injury: foe and friend Emerging biomarkers and metabolomics for assessing toxic nephropathy and acute kidney injury (AKI) in neonatology Biomarkers in nephrology: Core Curriculum 2013 Proteomic candidate biomarkers of drug-induced nephrotoxicity in the rat Development of an immunoassay for the kidney-specific protein myo-inositol oxygenase, a potential biomarker of acute kidney injury Systems toxicology of chemically induced liver and kidney injuries: histopathology-associated gene co-expression modules Life cycle analysis of kidney gene expression in male F344 rats The use of surrogate endpoints in regulating medicines for cardio-renal disease: opinions of stakeholders Postoperative biomarkers predict acute kidney injury and poor outcomes after adult cardiac surgery Mining kidney toxicogenomic data by using gene co-expression modules A basic science view of acute kidney injury biomarkers.Potential use of biomarkers in acute kidney injury: report and summary of recommendations from the 10th Acute Dialysis Quality Initiative consensus conference.Enteric neurons from Parkinson's disease patients display ex vivo aberrations in mitochondrial structure.Reference intervals for urinary renal injury biomarkers KIM-1 and NGAL in healthy children Performance of urinary neutrophil gelatinase-associated lipocalin, clusterin, and cystatin C in predicting diabetic kidney disease and diabetic microalbuminuria: a consecutive cohort study Serum TFF3 may be a pharamcodynamic marker of responses to chemotherapy in gastrointestinal cancers.Comparison of the course of biomarker changes and kidney injury in a rat model of drug-induced acute kidney injury.Biomarkers for drug-induced renal damage and nephrotoxicity-an overview for applied toxicology.Recommendations for the evaluation of pathology data in nonclinical safety biomarker qualification studies.Evaluation of novel renal biomarkers with a cisplatin model of kidney injury: gender and dosage differences.Development of a pharmaceutical hepatotoxicity biomarker panel using a discovery to targeted proteomics approach.Blood kidney injury molecule-1 is a biomarker of acute and chronic kidney injury and predicts progression to ESRD in type I diabetes Urinary biomarker detection of melamine- and cyanuric acid-induced kidney injury in rats.Variation of nephrotoxicity biomarkers by urinary storage condition in rats.Urinary biomarkers track the progression of nephropathy in hypertensive and obese rats.Gene expression of biomarkers of nephrotoxicity in F344 rats co-exposed to melamine and cyanuric acid for seven days Quantitative mass spectrometry of urinary biomarkers Successful drug development despite adverse preclinical findings part 2: examples.Role of biomarkers of nephrotoxic acute kidney injury in deliberate poisoning and envenomation in less developed countries A mixed grape and blueberry extract is safe for dogs to consume.Hsp72 is an early and sensitive biomarker to detect acute kidney injury.Role of urine neutrophil gelatinase-associated lipocalin in the early diagnosis of amphotericin B-induced acute kidney injury.Adaptive Bayesian approach to clinical trial renal impairment biomarker signal from urea and creatinine.Clinical review: Biomarkers of acute kidney injury: where are we now?Associations of urinary levels of kidney injury molecule 1 (KIM-1) and neutrophil gelatinase-associated lipocalin (NGAL) with kidney function decline in the Multi-Ethnic Study of Atherosclerosis (MESA).Performance of kidney injury molecule-1 and liver fatty acid-binding protein and combined biomarkers of AKI after cardiac surgery.Metabolomics in toxicology and preclinical research.

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Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium

http://www.wikidata.org/entity/Q58071225

description

article

@en

im Mai 2010 veröffentlichter wissenschaftlicher Artikel

@de

wetenschappelijk artikel

@nl

наукова стаття, опублікована в травні 2010

@uk

name

Renal biomarker qualification ...... tive Safety Testing Consortium

@en

Renal biomarker qualification ...... tive Safety Testing Consortium

@nl

type

label

Renal biomarker qualification ...... tive Safety Testing Consortium

@en

Renal biomarker qualification ...... tive Safety Testing Consortium

@nl

prefLabel

Renal biomarker qualification ...... tive Safety Testing Consortium

@en

Renal biomarker qualification ...... tive Safety Testing Consortium

@nl

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Nature Biotechnology

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Renal biomarker qualification ...... tive Safety Testing Consortium

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Albert F Defelice

http://www.w3.org/2001/XMLSchema#string

Aliza Thompson

http://www.w3.org/2001/XMLSchema#string

Anthony Senagore

http://www.w3.org/2001/XMLSchema#string

Beatriz Silva Lima

http://www.w3.org/2001/XMLSchema#string

Bruno Flamion

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Craig P Webb

http://www.w3.org/2001/XMLSchema#string

Dan Holder

http://www.w3.org/2001/XMLSchema#string

Daniela Ennulat

http://www.w3.org/2001/XMLSchema#string

David Honor

http://www.w3.org/2001/XMLSchema#string

David Jacobson-Kram

http://www.w3.org/2001/XMLSchema#string

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Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach

Disease-dependent mechanisms of albuminuria.

Biomarkers of acute renal injury and renal failure.

Urine biomarkers predict the cause of glomerular disease.

Next-generation biomarkers for detecting kidney toxicity

A panel of urinary biomarkers to monitor reversibility of renal injury and a serum marker with improved potential to assess renal function.

Urinary clusterin, cystatin C, beta2-microglobulin and total protein as markers to detect drug-induced kidney injury.

Fit-for-purpose method development and validation for successful biomarker measurement.

Towards consensus practices to qualify safety biomarkers for use in early drug development

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455-462

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scholarly article

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10.1038/NBT.1625

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5

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28

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Jonathan A Phillips

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2010-05-10T00:00:00Z

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20458315

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