(Q36045270)

11 August 2017

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title

Biomarkers and surrogate markers: an FDA perspective (English)

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11 August 2017

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Russell Katz

1

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11 August 2017

1 April 2004

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11 August 2017

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11 August 2017

1

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11 August 2017

2

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11 August 2017

189-195

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End points and United States Food and Drug Administration approval of oncology drugs

11 August 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=534924

Short-term correlations between clinical and MR imaging findings in relapsing-remitting multiple sclerosis.

2 October 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=534924

Leads for the development of neuroprotective treatment in Parkinson's disease and brain imaging methods for estimating treatment efficacy

2 October 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=534924

Surrogate end points in clinical trials: are we being misled?

2 October 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=534924

Effect of fluoride treatment on the fracture rate in postmenopausal women with osteoporosis

2 October 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=534924

Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial

2 October 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=534924

Slowing the progression of Alzheimer disease: methodologic issues.

2 October 2017

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=534924

Using serial registered brain magnetic resonance imaging to measure disease progression in Alzheimer disease: power calculations and estimates of sample size to detect treatment effects

11 July 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=534924

An [18F]dopa-PET and clinical study of the rate of progression in Parkinson's disease.

23 September 2018

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=534924

Consensus Report of the Working Group on: “Molecular and Biochemical Markers of Alzheimer’s Disease” 11The names of the Working Group Members and the names of the Working Group Advisory Committee Members are listed in the Appendix A(section VI)

23 September 2018

1 reference

Crossref

https://api.crossref.org/works/10.1602%2FNEURORX.1.2.189

Evaluating surrogate endpoints

21 January 2018

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12 December 2020

Are surrogate markers adequate to assess cardiovascular disease drugs?

1 reference

12 December 2020

Consensus report of the Working Group on: "Molecular and Biochemical Markers of Alzheimer's Disease". The Ronald and Nancy Reagan Research Institute of the Alzheimer's Association and the National Institute on Aging Working Group

1 reference

12 December 2020

New drug, antibiotic, and biological drug product regulations; accelerated approval--FDA. Final rule

1 reference

12 December 2020

Identifiers

DOI

10.1602/NEURORX.1.2.189

1 reference

11 August 2017

1 reference

PMC publication ID

534924

11 August 2017

PubMed publication ID

15717019

1 reference

PMC publication ID

534924