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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2 February 2020

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2 February 2020

Jonathan A Phillips

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2 February 2020

Gerald Maurer

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2 February 2020

Sean P Troth

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2 February 2020

author name string

Frank Dieterle

1

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2 February 2020

Frank Sistare

2

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2 February 2020

Federico Goodsaid

3

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Marisa Papaluca

4

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Josef S Ozer

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Craig P Webb

6

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2 February 2020

William Baer

7

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2 February 2020

Anthony Senagore

8

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Matthew J Schipper

9

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Jacky Vonderscher

10

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Stefan Sultana

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Kevin Carl

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David Laurie

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Ernie Harpur

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Manisha Sonee

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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

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Nancy Xu

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William Taylor

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Spiros Vamvakas

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Bruno Flamion

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Beatriz Silva Lima

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Peter Kasper

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Markku Pasanen

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Krishna Prasad

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Denise Bounous

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Denise Robinson-Gravatt

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Graham Betton

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Myrtle A Davis

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Jackie Akunda

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James Eric McDuffie

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Laura Suter

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Leslie Obert

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Magalie Guffroy

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Mark Pinches

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Supriya Jayadev

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Eric A Blomme

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Sven A Beushausen

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Valérie G Barlow

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Nathaniel Collins

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Jeff Waring

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David Honor

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Sandra Snook

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Jinhe Lee

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Phil Rossi

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Elizabeth Walker

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William Mattes

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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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2 February 2020

page(s)

455-462

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https://scigraph.springernature.com/pub.10.1038/nbt.1625

2 February 2020

exact match

0 references

cites work

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

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

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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

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https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:20458315%20AND%20SRC:MED&resulttype=core&format=json

2 February 2020

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