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Economic return of clinical trials performed under the pediatric exclusivity program.

Economic return of clinical trials performed under the pediatric exclusivity program.

http://www.wikidata.org/entity/Q37412752

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Safety and tolerability considerations in the use of sildenafil for children with pulmonary arterial hypertension Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review Paediatric cardiovascular clinical trials: an analysis of ClinicalTrials.gov and the Food and Drug Administration Pediatric Drug Labeling Database How to improve the implementation of academic clinical pediatric trials involving drug therapy? A qualitative study of multiple stakeholders Clinical research careers: reports from a NHLBI pediatric heart network clinical research skills development conference Characteristics of pediatric cardiovascular clinical trials registered on ClinicalTrials.gov.Challenges in conducting clinical trials in children: approaches for improving performance Implementation of NIH inclusion guidelines: survey of NIH study section members.Status of the pediatric clinical trials enterprise: an analysis of the US ClinicalTrials.gov registry.Economic analysis of centralized vs. decentralized electronic data capture in multi-center clinical studies Globalization of pediatric research: analysis of clinical trials completed for pediatric exclusivity.Controlled trials in children: quantity, methodological quality and descriptive characteristics of pediatric controlled trials published 1948-2006.Clinical trials in children An empirical review of major legislation affecting drug development: past experiences, effects, and unintended consequences.The economic returns of pediatric clinical trials of antihypertensive drugs.Postmarketing trials and pediatric device approvals.Academic pediatric clinical research: factors associated with study implementation duration New mechanistic and therapeutic targets for pediatric heart failure: report from a National Heart, Lung, and Blood Institute working group.Drug versus placebo randomized controlled trials in neonates: A review of ClinicalTrials.gov registry.Therapeutic hypothermia after pediatric cardiac arrest trials: the vanguard phase experience and implications for other trials.Safety monitoring of drugs receiving pediatric marketing exclusivity Recent developments and strategies in pediatric pharmacology research in the USA.Alendronate treatment of the brtl osteogenesis imperfecta mouse improves femoral geometry and load response before fracture but decreases predicted material properties and has detrimental effects on osteoblasts and bone formation Access to prescribing information for paediatric medicines in the USA: post-modernization.Institutional review boards lack the moral legitimacy to reinterpret subpart D.Safety and transparency of pediatric drug trials."Creating hope" and other incentives for drug development for children.Patent extension policy for paediatric indications: an evaluation of the impact within three drug classes in a state Medicaid programme.Limited capacity in US pediatric drug trials: qualitative analysis of expert interviews.The 21st century cures act: Opportunities and challenges.Measuring the patient health, societal and economic benefits of US pediatric therapeutics legislation.Safety of placebo controls in pediatric hypertension trials.Pharmaceutical research in paediatric populations and the new EU Paediatric Legislation: an industry perspective.Just a spoonful of sugar: drug safety for pediatric populations.Ethics and clinical trials in congenital heart disease.The clinical and financial impact of a pediatric surgical neuro-oncology clinical trial.Recommendations to Enhance Pediatric Cardiovascular Drug Development: Report of a Multi-Stakeholder Think Tank.Sensible approaches for reducing clinical trial costs.

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P2860

Economic return of clinical trials performed under the pediatric exclusivity program.

http://www.wikidata.org/entity/Q37412752

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article científic

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article scientifique

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articolo scientifico

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artigo científico

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bilimsel makale

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scientific article published on February 2007

@en

vedecký článok

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vetenskaplig artikel

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videnskabelig artikel

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vědecký článek

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name

Economic return of clinical trials performed under the pediatric exclusivity program.

@en

Economic return of clinical trials performed under the pediatric exclusivity program.

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type

label

Economic return of clinical trials performed under the pediatric exclusivity program.

@en

Economic return of clinical trials performed under the pediatric exclusivity program.

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prefLabel

Economic return of clinical trials performed under the pediatric exclusivity program.

@en

Economic return of clinical trials performed under the pediatric exclusivity program.

@nl

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Journal of the American Medical Association

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Economic return of clinical trials performed under the pediatric exclusivity program.

@en

P2093

Barry Mangum

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Daniel K Benjamin

http://www.w3.org/2001/XMLSchema#string

Elizabeth D Reid

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Eric L Eisenstein

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Henry G Grabowski

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Jennifer S Li

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John V Goldsmith

http://www.w3.org/2001/XMLSchema#string

Kevin A Schulman

http://www.w3.org/2001/XMLSchema#string

M Dianne Murphy

http://www.w3.org/2001/XMLSchema#string

P2860

The Patents-Based Pharmaceutical Development Process

Safety and pharmacokinetics of intravenous anidulafungin in children with neutropenia at high risk for invasive fungal infections.

Peer-reviewed publication of clinical trials completed for pediatric exclusivity

Suicide caution stamped on antidepressants.

Is the extrapolated adult dose of fosinopril safe and effective in treating hypertensive children?

A randomized, placebo-controlled trial of amlodipine in children with hypertension.

A black-box warning for antidepressants in children?

Antidepressants and pediatric depression--the risk of doing nothing.

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480-488

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10.1001/JAMA.297.5.480

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