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Literature DB >> 28669447

2017 ACC/AAP/AHA Health Policy Statement on Opportunities and Challenges in Pediatric Drug Development: Learning From Sildenafil.

Craig A Sable, D Dunbar Ivy, Robert H Beekman, Helene D Clayton-Jeter, Kathy J Jenkins, William T Mahle, William R Morrow, Mary Dianne Murphy, Robert M Nelson, Geoffrey L Rosenthal, Norman Stockbridge, David L Wessel.

Abstract

Entities: Chemical Disease Gene Species

Keywords: Health Policy Statement; U.S. Food and Drug Administration; drug development; pediatric clinical trials; sildenafil

Mesh：

Substances：

Year: 2017 PMID： 28669447 PMCID： PMC5590643 DOI： 10.1016/j.jacc.2017.04.007

Source DB: PubMed Journal: J Am Coll Cardiol ISSN： 0735-1097 Impact factor: 24.094

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24 in total

1. Extrapolation of adult data and other data in pediatric drug-development programs.

Authors: Julia Dunne; William J Rodriguez; M Dianne Murphy; B Nhi Beasley; Gilbert J Burckart; Jane D Filie; Linda L Lewis; Hari C Sachs; Philip H Sheridan; Peter Starke; Lynne P Yao
Journal: Pediatrics Date: 2011-10-24 Impact factor: 7.124

2. STARTS-2: long-term survival with oral sildenafil monotherapy in treatment-naive pediatric pulmonary arterial hypertension.

Authors: Robyn J Barst; Maurice Beghetti; Tomas Pulido; Gary Layton; Irina Konourina; Min Zhang; D Dunbar Ivy
Journal: Circulation Date: 2014-03-17 Impact factor: 29.690

3. Pediatric pulmonary hypertension in the Netherlands: epidemiology and characterization during the period 1991 to 2005.

Authors: Rosa Laura E van Loon; Marcus T R Roofthooft; Hans L Hillege; Arend D J ten Harkel; Magdalena van Osch-Gevers; Tammo Delhaas; Livia Kapusta; Jan L M Strengers; Lukas Rammeloo; Sally-Ann B Clur; Barbara J M Mulder; Rolf M F Berger
Journal: Circulation Date: 2011-09-26 Impact factor: 29.690

4. Impact of pediatric exclusivity on drug labeling and demonstrations of efficacy.

Authors: Gerold T Wharton; M Dianne Murphy; Debbie Avant; John V Goldsmith; Grace Chai; William J Rodriguez; Eric L Eisenstein
Journal: Pediatrics Date: 2014-07-14 Impact factor: 7.124

5. Atenolol versus losartan in children and young adults with Marfan's syndrome.

Authors: Ronald V Lacro; Harry C Dietz; Lynn A Sleeper; Anji T Yetman; Timothy J Bradley; Steven D Colan; Gail D Pearson; E Seda Selamet Tierney; Jami C Levine; Andrew M Atz; D Woodrow Benson; Alan C Braverman; Shan Chen; Julie De Backer; Bruce D Gelb; Paul D Grossfeld; Gloria L Klein; Wyman W Lai; Aimee Liou; Bart L Loeys; Larry W Markham; Aaron K Olson; Stephen M Paridon; Victoria L Pemberton; Mary Ella Pierpont; Reed E Pyeritz; Elizabeth Radojewski; Mary J Roman; Angela M Sharkey; Mario P Stylianou; Stephanie Burns Wechsler; Luciana T Young; Lynn Mahony
Journal: N Engl J Med Date: 2014-11-18 Impact factor: 91.245

6. Randomized trial of pulsed corticosteroid therapy for primary treatment of Kawasaki disease.

Authors: Jane W Newburger; Lynn A Sleeper; Brian W McCrindle; L LuAnn Minich; Welton Gersony; Victoria L Vetter; Andrew M Atz; Jennifer S Li; Masato Takahashi; Annette L Baker; Steven D Colan; Paul D Mitchell; Gloria L Klein; Robert P Sundel
Journal: N Engl J Med Date: 2007-02-15 Impact factor: 91.245

7. The Pediatric Heart Network: a primer for the conduct of multicenter studies in children with congenital and acquired heart disease.

Authors: L Mahony; L A Sleeper; P A W Anderson; W M Gersony; B W McCrindle; L L Minich; J W Newburger; J P Saul; V L Vetter; G D Pearson
Journal: Pediatr Cardiol Date: 2006 Mar-Apr Impact factor: 1.655

2017 ACC/AAP/AHA Health Policy Statement on Opportunities and Challenges in Pediatric Drug Development: Learning From Sildenafil.

1. Extrapolation of adult data and other data in pediatric drug-development programs.

2. STARTS-2: long-term survival with oral sildenafil monotherapy in treatment-naive pediatric pulmonary arterial hypertension.

3. Pediatric pulmonary hypertension in the Netherlands: epidemiology and characterization during the period 1991 to 2005.

4. Impact of pediatric exclusivity on drug labeling and demonstrations of efficacy.

5. Atenolol versus losartan in children and young adults with Marfan's syndrome.

6. Randomized trial of pulsed corticosteroid therapy for primary treatment of Kawasaki disease.

7. The Pediatric Heart Network: a primer for the conduct of multicenter studies in children with congenital and acquired heart disease.

8. Off-label drug use in a single-center pediatric cardiac intensive care unit.

9. The globalization of pediatric clinical trials.

10. Off-label use of cardiovascular medications in children hospitalized with congenital and acquired heart disease.

Review 1. Treatment of pediatric pulmonary arterial hypertension: A focus on the NO-sGC-cGMP pathway.