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Author Details

Dianne Murphy
1979
54
23
PMIDPaper TitleJournal TitlePublished Year
30452504Duration of Pediatric Clinical Trials Submitted to the US Food and Drug Administration.JAMA Pediatr2019
29029810Characteristics and Changes of Pediatric Therapeutic Trials under the Best Pharmaceuticals for Children Act.J Pediatr2018
29440007Recommendations to Enhance Pediatric Cardiovascular Drug Development: Report of a Multi-Stakeholder Think Tank.J Am Heart Assoc2018
28942898The Need for Pediatric Drug Development.J Pediatr2018
28890858Extrapolation of Efficacy in Pediatric Drug Development and Evidence-based Medicine: Progress and Lessons Learned.Ther Innov Regul Sci2017
28674673Pediatric Medicine Development: An Overview and Comparison of Regulatory Processes in the European Union and United States.Ther Innov Regul Sci2017
286694472017 ACC/AAP/AHA Health Policy Statement on Opportunities and Challenges in Pediatric Drug Development: Learning From Sildenafil.J Am Coll Cardiol2017
286634372017 ACC/AAP/AHA Health Policy Statement on Opportunities and Challenges in Pediatric Drug Development: Learning From Sildenafil.Circ Cardiovasc Qual Outcomes2017
26687996Pediatric registries at the Food and Drug Administration: design aspects that increase their likelihood of success.Pharmacoepidemiol Drug Saf2016
28943808The Role of Biomarkers and Surrogate End Points in Drug Development for Neonatal Pulmonary Arterial Hypertension.Neoreviews2016
27416322Reliable and developmentally appropriate study end points are needed to achieve drug development for treatment of pediatric pulmonary arterial hypertension.J Perinatol2016
27274951A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA from 2007-2013.Ther Innov Regul Sci2016
26098297Pediatric post-marketing safety systems in North America: assessment of the current status.Pharmacoepidemiol Drug Saf2015
26598453FDA Safety Reviews on Drugs, Biologics, and Vaccines: 2007-2013.Pediatrics2015
26248129Infant formula and neurocognitive outcomes: impact of study end-point selection.J Perinatol2015
24488740Pediatric oncology drug shortages: a multifaceted problem.Pediatrics2014
25022732Impact of pediatric exclusivity on drug labeling and demonstrations of efficacy.Pediatrics2014
23359002Migraine therapeutics in adolescents: a systematic analysis and historic perspectives of triptan trials in adolescents.JAMA Pediatr2013
22570457Pediatric information in drug product labeling.JAMA2012
23129087The globalization of pediatric clinical trials.Pediatrics2012
22711728Trends of outpatient prescription drug utilization in US children, 2002-2010.Pediatrics2012
21196576The globalization of pediatric trials: should we be worried?Pediatrics2011
22025597Extrapolation of adult data and other data in pediatric drug-development programs.Pediatrics2011
22025595Age and risks of FDA-approved long-acting β⿿-adrenergic receptor agonists.Pediatrics2011
20130570Cough in pediatric patients receiving angiotensin-converting enzyme inhibitor therapy or angiotensin receptor blocker therapy in randomized controlled trials.Clin Pharmacol Ther2010
19996043Safety and transparency of pediatric drug trials.Arch Pediatr Adolesc Med2009
18332283Pediatric antihypertensive trial failures: analysis of end points and dose range.Hypertension2008
18762496Safety monitoring of drugs receiving pediatric marketing exclusivity.Pediatrics2008
18833025Amoxicillin for postexposure inhalational anthrax in pediatrics: rationale for dosing recommendations.Pediatr Infect Dis J2008
18926149The economic returns of pediatric clinical trials of antihypertensive drugs.Am Heart J2008
18548000Racial differences in blood pressure response to angiotensin-converting enzyme inhibitors in children: a meta-analysis.Clin Pharmacol Ther2008
18285612Safety of placebo controls in pediatric hypertension trials.Hypertension2008
18310202Improving pediatric dosing through pediatric initiatives: what we have learned.Pediatrics2008
17284698Economic return of clinical trials performed under the pediatric exclusivity program.JAMA2007
16540810Child and adolescent psychopharmacology in the new millennium: a workshop for academia, industry, and government.J Am Acad Child Adolesc Psychiatry2006
16968851Peer-reviewed publication of clinical trials completed for pediatric exclusivity.JAMA2006
15306995US Food and Drug Administration approval of ciprofloxacin hydrochloride for management of postexposure inhalational anthrax.Clin Infect Dis2004
12733470Increased US prescription trends associated with the CDC Bacillus anthracis antimicrobial postexposure prophylaxis campaign.Pharmacoepidemiol Drug Saf2003
12928467Pediatric drug labeling: improving the safety and efficacy of pediatric therapies.JAMA2003
14685077Current regulatory policies regarding pediatric indications and exclusivity.J Pediatr Gastroenterol Nutr2003
12377082Guidelines for treatment of anthrax.JAMA2002
8013163Paediatric labelling requirements. Implications for pharmacokinetic studies.Clin Pharmacokinet1994
11653140Women in clinical trials: HIV-infected women.Food Drug Law J1993
2915431Respiratory syncytial virus pneumonia in a human immunodeficiency virus-infected man.JAMA1989
3763420Effect of different components of a laboratory curriculum on resident physician learning.Pediatr Infect Dis1986
3975131Unusual syndrome among premature infants: association with a new intravenous vitamin E product.Pediatrics1985
6889163A clinical laboratory program to improve performance of resident physicians.Pediatr Infect Dis1983
6876129Pediatric house staff communication skills: assessment and intervention.J Med Educ1983
6406988Series: infectious diseases and the office laboratory. Office laboratory diagnosis of sexually transmitted diseases.Pediatr Infect Dis1983
7252673Bronchomammary axis in the immune response to respiratory syncytial virus.J Pediatr1981
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Collaborators

Robert M Califf
From the National Institutes of Health
Co-authored papers 9
Norman Stockbridge
Center for Drug Evaluation and Research
Co-authored papers 5
Ann W McMahon
Center for Drug Evaluation and Research
Co-authored papers 5
Carissa M Baker-Smith
Nemours Children's Hospital
Co-authored papers 4
Dunbar Ivy
Heart Institute, Children's Hospital Colorado, University of Colorado
Co-authored papers 3
Geoffrey L Rosenthal
University of Maryland School of Medicine
Co-authored papers 3
Robert M Nelson
The Ottawa Hospital, University of Ottawa
Co-authored papers 3
Craig Sable
Children's National Hospital
Co-authored papers 2
William R Morrow
Children's Medical Center of Dallas
Co-authored papers 2
William T Mahle
Emory University
Co-authored papers 2
Kathy J Jenkins
Boston Children's Hospital
Co-authored papers 2
David L Wessel
Children's National Hospital, George Washington University School of Medicine
Co-authored papers 2
Robert H Beekman
University of Michigan Congenital Heart Center ann arbor
Co-authored papers 2
Helene D Clayton-Jeter
Co-authored papers 2
Kevin D Hill
Duke University Medical Center
Co-authored papers 1
Robert Temple
Co-authored papers 1
Richard C Rose
Co-authored papers 1
Gregory H Reaman
National Cancer Institute
Co-authored papers 1
Jane W Newburger
Boston Children's Hospital
Co-authored papers 1
Release 1.2