Literature DB >> 28114560

The Pediatric Research Equity Act Moves Into Adolescence.

Florence T Bourgeois1, Thomas J Hwang2.   

Abstract

Mesh：

Year:  2017        PMID： 28114560     DOI： 10.1001/jama.2016.18131

Source DB:  PubMed          Journal:  JAMA        ISSN： 0098-7484            Impact factor:   56.272


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  12 in total

1.  Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act.

Authors:  Thomas J Hwang; Liat Orenstein; Aaron S Kesselheim; Florence T Bourgeois
Journal:  JAMA Pediatr       Date:  2019-01-01       Impact factor: 16.193

Review 2.  Generic Substitution of Orphan Drugs for the Treatment of Rare Diseases: Exploring the Potential Challenges.

Authors:  Antonello Di Paolo; Elena Arrigoni
Journal:  Drugs       Date:  2018-03       Impact factor: 9.546

3.  Pediatric Trials for Cancer Therapies With Targets Potentially Relevant to Pediatric Cancers.

Authors:  Thomas J Hwang; Liat Orenstein; Steven G DuBois; Katherine A Janeway; Florence T Bourgeois
Journal:  J Natl Cancer Inst       Date:  2020-03-01       Impact factor: 13.506

4.  Trends in Off-Label Drug Use in Ambulatory Settings: 2006-2015.

Authors:  Divya Hoon; Matthew T Taylor; Pooja Kapadia; Tobias Gerhard; Brian L Strom; Daniel B Horton
Journal:  Pediatrics       Date:  2019-09-16       Impact factor: 7.124

5.  Surfactant Administration in Preterm Infants: Drug Development Opportunities.

Authors:  Genevieve Taylor; Wesley Jackson; Christoph P Hornik; Alec Koss; Sreekar Mantena; Kenya Homsley; Blair Gattis; Menefese Kudumu-Clavell; Reese Clark; P Brian Smith; Matthew M Laughon
Journal:  J Pediatr       Date:  2018-12-21       Impact factor: 6.314

6.  Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union: A cohort study.

Authors:  Thomas J Hwang; Paolo A Tomasi; Florence T Bourgeois
Journal:  PLoS Med       Date:  2018-03-01       Impact factor: 11.069

7.  Developing a pediatric pain data repository.

Authors:  Carolina Donado; Kimberly Lobo; Charles B Berde; Florence T Bourgeois
Journal:  JAMIA Open       Date:  2019-11-27

Review 8.  Enhancing clinical trial development for pediatric kidney diseases.

Authors:  H William Schnaper; Joseph T Flynn; Coleman Gross; Anne B Cropp; Bastian Dehmel; Leah B Patel; Larry A Greenbaum; Elisabeth Houtsmuller; Frederick Kaskel; Marva Moxey-Mims; Karen Nowak; Douglas Silverstein; Aliza Thompson; Lynne Yao; Edress Darsey; William E Smoyer
Journal:  Pediatr Res       Date:  2017-08-30       Impact factor: 3.756

9.  Noncompletion and nonpublication of trials studying rare diseases: A cross-sectional analysis.

Authors:  Chris A Rees; Natalie Pica; Michael C Monuteaux; Florence T Bourgeois
Journal:  PLoS Med       Date:  2019-11-21       Impact factor: 11.069

10.  Adverse drug event presentation and tracking (ADEPT): semiautomated, high throughput pharmacovigilance using real-world data.

Authors:  Alon Geva; Jason P Stedman; Shannon F Manzi; Chen Lin; Guergana K Savova; Paul Avillach; Kenneth D Mandl
Journal:  JAMIA Open       Date:  2020-08-31
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