Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact (Q43049704)

12 November 2017

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title

Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact (English)

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12 November 2017

Ina Schuppe-Koistinen

26

object named as

Ina Schuppe-Koistinen

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12 November 2017

Albert J Fornace

11

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Weida Tong

29

object named as

Weida Tong

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12 November 2017

27

Leming Shi

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12 November 2017

13

Huixiao Hong

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12 November 2017

2

Shashi Amur

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12 November 2017

1

Federico M Goodsaid

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12 November 2017

6

Jennifer Catalano

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12 November 2017

Jiri Aubrecht

3

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12 November 2017

Michael E Burczynski

4

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12 November 2017

Kevin Carl

5

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12 November 2017

Rosane Charlab

7

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12 November 2017

Sandra Close

8

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12 November 2017

Catherine Cornu-Artis

9

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12 November 2017

Laurent Essioux

10

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12 November 2017

Lois Hinman

12

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12 November 2017

Ian Hunt

14

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12 November 2017

David Jacobson-Kram

15

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12 November 2017

Ansar Jawaid

16

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12 November 2017

David Laurie

17

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12 November 2017

Lawrence Lesko

18

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12 November 2017

Heng-Hong Li

19

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12 November 2017

Klaus Lindpaintner

20

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12 November 2017

James Mayne

21

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12 November 2017

Peter Morrow

22

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12 November 2017

Marisa Papaluca-Amati

23

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12 November 2017

Timothy W Robison

24

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12 November 2017

John Roth

25

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12 November 2017

Olivia Spleiss

28

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12 November 2017

Sharada L Truter

30

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12 November 2017

Jacky Vonderscher

31

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12 November 2017

Agnes Westelinck

32

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12 November 2017

Li Zhang

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12 November 2017

Issam Zineh

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12 November 2017

1 June 2010

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Nature Reviews Drug Discovery

12 November 2017

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12 November 2017

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12 November 2017

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12 November 2017

435-445

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https://scigraph.springernature.com/pub.10.1038/nrd3116

12 November 2017

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cites work

Pharmacogenomic-guided drug development: regulatory perspective

1 reference

Implementing the U.S. FDA guidance on pharmacogenomic data submissions

31 March 2020

1 reference

The experience with voluntary genomic data submissions at the FDA and a vision for the future of the voluntary data submission program

31 March 2020

1 reference

Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma

31 March 2020

1 reference

Population pharmacokinetics of CCI-779: correlations to safety and pharmacogenomic responses in patients with advanced renal cancer

31 March 2020

1 reference

Transcriptional profiling of peripheral blood cells in clinical pharmacogenomic studies

31 March 2020

1 reference

Randomized phase II study of multiple dose levels of CCI-779, a novel mammalian target of rapamycin kinase inhibitor, in patients with advanced refractory renal cell carcinoma

31 March 2020

1 reference

Molecular classification of cancer: class discovery and class prediction by gene expression monitoring

31 March 2020

1 reference

Using RNA sample titrations to assess microarray platform performance and normalization techniques

31 March 2020

1 reference

Evaluation of DNA microarray results with quantitative gene expression platforms

31 March 2020

1 reference

Opportunities posed by novel patient selection biomarker approaches in oncology drug development: going beyond the cytotoxics

31 March 2020

1 reference

Use of ex vivo systems for biomarker discovery

31 March 2020

1 reference

Discovery and implementation of transcriptional biomarkers of synthetic LXR agonists in peripheral blood cells

31 March 2020

1 reference

Predicting fluorouracil toxicity: can we finally do it?

31 March 2020

1 reference

Dihydropyrimidine dehydrogenase and the efficacy and toxicity of 5-fluorouracil

31 March 2020

1 reference

Prasugrel versus clopidogrel in patients with acute coronary syndromes

31 March 2020

1 reference

Multiplex assay for comprehensive genotyping of genes involved in drug metabolism, excretion, and transport

31 March 2020

1 reference

Comprehensive assessment of metabolic enzyme and transporter genes using the Affymetrix Targeted Genotyping System

31 March 2020

1 reference

Cytochrome P450 genetic polymorphisms and the response to prasugrel: relationship to pharmacokinetic, pharmacodynamic, and clinical outcomes

31 March 2020

1 reference

Cytochrome p-450 polymorphisms and response to clopidogrel

31 March 2020

1 reference

Genetic variation of CYP2C19 affects both pharmacokinetic and pharmacodynamic responses to clopidogrel but not prasugrel in aspirin-treated patients with coronary artery disease

31 March 2020

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Hepatic findings in long-term clinical trials of ximelagatran

31 March 2020

1 reference

Observations of alanine aminotransferase and aspartate aminotransferase in THRIVE studies treated orally with ximelagatran

31 March 2020

1 reference

Prediction of drug-induced liver injury in humans by using in vitro methods: the case of ximelagatran

31 March 2020

1 reference

Genome-wide pharmacogenetic investigation of a hepatic adverse event without clinical signs of immunopathology suggests an underlying immune pathogenesis

31 March 2020

1 reference

A systems biology approach to understanding elevated serum alanine transaminase levels in a clinical trial with ximelagatran

31 March 2020

1 reference

Qualification of biomarkers for drug development in organ transplantation.

31 March 2020

1 reference

Late kidney allograft loss: what we know about it, and what we can do about it

31 March 2020

1 reference

Chronic allograft nephropathy: current concepts and future directions

31 March 2020

1 reference

Protocol biopsies in renal transplantation: prognostic value of structural monitoring

31 March 2020

1 reference

Kidney allograft fibrosis and atrophy early after living donor transplantation.

31 March 2020

1 reference

Early prognosis of the development of renal chronic allograft rejection by gene expression profiling of human protocol biopsies

31 March 2020

1 reference

A review of the genotoxicity of marketed pharmaceuticals

31 March 2020

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Gene expression profile analysis: an emerging approach to investigate mechanisms of genotoxicity

31 March 2020

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Improving prediction of chemical carcinogenicity by considering multiple mechanisms and applying toxicogenomic approaches

31 March 2020

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Stress-specific signatures: expression profiling of p53 wild-type and -null human cells

31 March 2020

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Thresholds in genotoxicity responses.

31 March 2020

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Indirect mechanisms of genotoxicity

31 March 2020

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The effect of methylxanthines on chromosomes of human lymphocytes in culture

31 March 2020

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Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective

31 March 2020

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12 December 2020

Disease-associated expression profiles in peripheral blood mononuclear cells from patients with advanced renal cell carcinoma.

1 reference

12 December 2020

Clinical pharmacokinetics of 5-fluorouracil and its metabolites in plasma, urine, and bile

1 reference

12 December 2020

Decreased dihydropyrimidine dehydrogenase activity in a population of patients with breast cancer: implication for 5-fluorouracil-based chemotherapy.

1 reference

12 December 2020

Transcriptional profiles in peripheral blood mononuclear cells prognostic of clinical outcomes in patients with advanced renal cell carcinoma

1 reference

12 December 2020

Evaluation of normalization procedures for oligonucleotide array data based on spiked cRNA controls

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12 December 2020

Identifiers

DOI

10.1038/NRD3116

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12 November 2017

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