Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium (Q58071225)

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2 February 2020

title

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

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Jonathan A Phillips

13

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Gerald Maurer

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Sean P Troth

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author name string

Frank Dieterle

1

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Frank Sistare

2

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Federico Goodsaid

3

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Marisa Papaluca

4

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Josef S Ozer

5

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Craig P Webb

6

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William Baer

7

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Anthony Senagore

8

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Matthew J Schipper

9

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Jacky Vonderscher

10

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Stefan Sultana

11

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Kevin Carl

15

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David Laurie

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Ernie Harpur

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Manisha Sonee

18

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Daniela Ennulat

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Dan Holder

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Dina Andrews-Cleavenger

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Yi-Zhong Gu

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Karol L Thompson

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Peter L Goering

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Jean-Marc Vidal

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Eric Abadie

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Romaldas Maciulaitis

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David Jacobson-Kram

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Albert F Defelice

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Elizabeth A Hausner

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Melanie Blank

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Aliza Thompson

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Patricia Harlow

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Douglas Throckmorton

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Shen Xiao

35

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Nancy Xu

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William Taylor

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Spiros Vamvakas

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Graham Betton

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Sandra Snook

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publication date

10 May 2010

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2 February 2020

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volume

28

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issue

5

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page(s)

455-462

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

2 February 2020

cites work

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Urine biomarkers predict the cause of glomerular disease.

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Biomarkers of acute renal injury and renal failure

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

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

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PubMed

https://pubmed.ncbi.nlm.nih.gov/20458315

inferred from PubMed ID database lookup

12 December 2020

based on heuristic

A prototypical process for creating evidentiary standards for biomarkers and diagnostics

1 reference

PubMed

https://pubmed.ncbi.nlm.nih.gov/20458315

inferred from PubMed ID database lookup

12 December 2020

based on heuristic

Identifiers

DOI

10.1038/NBT.1625

1 reference

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2 February 2020

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