Literature DB >> 28663437

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

Craig A Sable1, D Dunbar Ivy1, Robert H Beekman1, Helene D Clayton-Jeter1, Kathy J Jenkins1, William T Mahle1, William R Morrow1, Mary Dianne Murphy1, Robert M Nelson1, Geoffrey L Rosenthal1, Norman Stockbridge1, David L Wessel1.   

Abstract

Entities:  

Keywords:  AHA Scientific Statements; US Food and Drug Administration; drug development; pediatric clinical trials; sildenafil

Mesh:

Substances:

Year:  2017        PMID: 28663437      PMCID: PMC5614492          DOI: 10.1161/HCQ.0000000000000026

Source DB:  PubMed          Journal:  Circ Cardiovasc Qual Outcomes        ISSN: 1941-7713


× No keyword cloud information.
  25 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.  New drug, antibiotic, and biological drug product regulations; accelerated approval--FDA. Final rule.

Authors: 
Journal:  Fed Regist       Date:  1992-12-11

3.  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

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

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

Authors:  Lily A Maltz; Darren Klugman; Michael C Spaeder; David L Wessel
Journal:  World J Pediatr Congenit Heart Surg       Date:  2013-07

9.  The globalization of pediatric clinical trials.

Authors:  Julia Dunne; M Dianne Murphy; William J Rodriguez
Journal:  Pediatrics       Date:  2012-11-05       Impact factor: 7.124

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

Authors:  Sara K Pasquali; Matthew Hall; Anthony D Slonim; Kathy J Jenkins; Bradley S Marino; Meryl S Cohen; Samir S Shah
Journal:  Circ Cardiovasc Qual Outcomes       Date:  2008-11-05
View more

北京卡尤迪生物科技股份有限公司 © 2022-2023.