(Q37498254)

20 August 2017

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title

The value, qualification, and regulatory use of surrogate end points in drug development (English)

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20 August 2017

C D Lathia

1

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20 August 2017

D Amakye

2

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20 August 2017

W Dai

3

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20 August 2017

C Girman

4

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20 August 2017

S Madani

5

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20 August 2017

J Mayne

6

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20 August 2017

P MacCarthy

7

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20 August 2017

P Pertel

8

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20 August 2017

L Seman

9

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20 August 2017

A Stoch

10

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20 August 2017

P Tarantino

11

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20 August 2017

C Webster

12

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20 August 2017

S Williams

13

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20 August 2017

J A Wagner

14

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20 August 2017

language of work or name

English

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publication date

27 May 2009

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Clinical Pharmacology & Therapeutics

20 August 2017

published in

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20 August 2017

volume

86

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20 August 2017

issue

1

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20 August 2017

page(s)

32-43

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Plasma viral load and CD4+ lymphocytes as prognostic markers of HIV-1 infection

20 August 2017

cites work

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

Leuprolide versus diethylstilbestrol for metastatic prostate cancer

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

Pre-existing fractures and bone mass predict vertebral fracture incidence in women

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

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

21 January 2018

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

Changes in plasma HIV RNA levels and CD4+ lymphocyte counts predict both response to antiretroviral therapy and therapeutic failure. VA Cooperative Study Group on AIDS

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

Intermittent and sustained low-level HIV viral rebound in patients receiving potent antiretroviral therapy

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

Prevalence and predictive value of intermittent viremia with combination hiv therapy

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https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators

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https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

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

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https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

Clinical trials for registration in the European Union: the EMEA 5-year experience in oncology

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

Contributions of the Framingham Study to the conquest of coronary artery disease

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https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

Simvastatin with or without ezetimibe in familial hypercholesterolemia

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https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

Does ENHANCE diminish confidence in lowering LDL or in ezetimibe?

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

10-year follow-up of intensive glucose control in type 2 diabetes

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

Glyburide/metformin tablets: a new therapeutic option for the management of Type 2 diabetes

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

Effects of intensive glucose lowering in type 2 diabetes

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

Effects of different blood-pressure-lowering regimens on major cardiovascular events: results of prospectively-designed overviews of randomised trials

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

THE ROLE OF BLOOD-PRESSURE CONTROL IN PREVENTING COMPLICATIONS OF HYPERTENSION

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

Targeting the androgen receptor: improving outcomes for castration-resistant prostate cancer

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

Management of cancer of the prostate

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

Gonadotropin-releasing hormone and its analogues

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

The treatment of metastatic prostatic cancer with the slow release LH-RH analogue Zoladex ICI 118630.

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: criteria, validation, strategies

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

Bone density at various sites for prediction of hip fractures. The Study of Osteoporotic Fractures Research Group

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

Effect of the fluoride/calcium regimen on vertebral fracture occurrence in postmenopausal osteoporosis. Comparison with conventional therapy.

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

A randomized trial of sodium fluoride as a treatment for postmenopausal osteoporosis

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

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

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

The WHI estrogen-alone trial--do things look any better?

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

Surrogate endpoints in clinical trials: definition and operational criteria

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

A cost-effectiveness approach to the qualification and acceptance of biomarkers

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

A prototypical process for creating evidentiary standards for biomarkers and diagnostics

1 reference

https://api.crossref.org/works/10.1038%2FCLPT.2009.69

7 January 2021

Identifiers

DOI

10.1038/CLPT.2009.69

1 reference

20 August 2017

1 reference