(Q33369050)

26 July 2017

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title

Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma (English)

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26 July 2017

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Hans-Georg Eichler

1

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26 July 2017

Francesco Pignatti

2

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26 July 2017

Bruno Flamion

3

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26 July 2017

Hubert Leufkens

4

1 reference

26 July 2017

Alasdair Breckenridge

5

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26 July 2017

12 September 2008

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Nature Reviews Drug Discovery

26 July 2017

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26 July 2017

7

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26 July 2017

10

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26 July 2017

818-826

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https://scigraph.springernature.com/pub.10.1038/nrd2664

26 July 2017

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cites work

Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction

1 reference

The FDA and the case of Ketek

21 January 2018

1 reference

How can we regulate medicines better?

31 March 2020

1 reference

Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes

31 March 2020

1 reference

Drug-review deadlines and safety problems

31 March 2020

1 reference

Regulatory policies on medicines for psychiatric disorders: is Europe on target?

31 March 2020

1 reference

Availability of comparative trials for the assessment of new medicines in the European Union at the moment of market authorization

31 March 2020

1 reference

The review of drug applications submitted to the European Medicines Evaluation Agency: frequently raised objections, and outcome

31 March 2020

1 reference

Surgeons' attitudes to intraoperative death. Cardiac surgeons might have different attitudes

31 March 2020

1 reference

Can the pharmaceutical industry reduce attrition rates?

31 March 2020

1 reference

Paying for drug approvals--who's using whom?

31 March 2020

1 reference

Accelerated approval regulations may need overhaul, panel suggests

31 March 2020

1 reference

Effects of torcetrapib in patients at high risk for coronary events

31 March 2020

1 reference

Thiazolidinediones, deadly sins, surrogates, and elephants.

31 March 2020

1 reference

Novel diabetes drugs to face higher hurdles?

31 March 2020

1 reference

Accelerated approval of oncology products: a decade of experience

31 March 2020

1 reference

The application of discovery toxicology and pathology towards the design of safer pharmaceutical lead candidates

31 March 2020

1 reference

Cardiovascular thromboembolic adverse effects associated with cyclooxygenase-2 selective inhibitors and nonselective antiinflammatory drugs

31 March 2020

1 reference

Role of Drug Disposition in Drug Hypersensitivity: A Chemical, Molecular, and Clinical Perspective

31 March 2020

1 reference

Bolstering the FDA's drug-safety authority

31 March 2020

1 reference

Cutting the cost of drug development?

31 March 2020

1 reference

Non-inferiority trials are unethical because they disregard patients' interests

31 March 2020

1 reference

Learning versus confirming in clinical drug development

31 March 2020

1 reference

Drug safety reform at the FDA--pendulum swing or systematic improvement?

31 March 2020

1 reference

In defense of pharmacoepidemiology--embracing the yin and yang of drug research

31 March 2020

1 reference

Approaches to evaluation of treatment effect in randomized clinical trials with genomic subset

31 March 2020

1 reference

Observational research, randomised trials, and two views of medical science

31 March 2020

1 reference

Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration

31 March 2020

1 reference

31 March 2020

Identifiers

DOI

10.1038/NRD2664

1 reference

26 July 2017

1 reference