BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

197 related articles for article (PubMed ID: 19996043)

  • 1. Safety and transparency of pediatric drug trials.
    Benjamin DK; Smith PB; Sun MJ; Murphy MD; Avant D; Mathis L; Rodriguez W; Califf RM; Li JS
    Arch Pediatr Adolesc Med; 2009 Dec; 163(12):1080-6. PubMed ID: 19996043
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Peer-reviewed publication of clinical trials completed for pediatric exclusivity.
    Benjamin DK; Smith PB; Murphy MD; Roberts R; Mathis L; Avant D; Califf RM; Li JS
    JAMA; 2006 Sep; 296(10):1266-73. PubMed ID: 16968851
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Labeling Changes and Costs for Clinical Trials Performed Under the US Food and Drug Administration Pediatric Exclusivity Extension, 2007 to 2012.
    Sinha MS; Najafzadeh M; Rajasingh EK; Love J; Kesselheim AS
    JAMA Intern Med; 2018 Nov; 178(11):1458-1466. PubMed ID: 30264138
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act.
    Hwang TJ; Orenstein L; Kesselheim AS; Bourgeois FT
    JAMA Pediatr; 2019 Jan; 173(1):68-74. PubMed ID: 30452498
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Impact of pediatric exclusivity on drug labeling and demonstrations of efficacy.
    Wharton GT; Murphy MD; Avant D; Goldsmith JV; Chai G; Rodriguez WJ; Eisenstein EL
    Pediatrics; 2014 Aug; 134(2):e512-8. PubMed ID: 25022732
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Pediatric drug labeling: improving the safety and efficacy of pediatric therapies.
    Roberts R; Rodriguez W; Murphy D; Crescenzi T
    JAMA; 2003 Aug; 290(7):905-11. PubMed ID: 12928467
    [TBL] [Abstract][Full Text] [Related]  

  • 7. FDA Safety Reviews on Drugs, Biologics, and Vaccines: 2007-2013.
    Cope JU; Rosenthal GL; Weinel P; Odegaard A; Murphy DM
    Pediatrics; 2015 Dec; 136(6):1125-31. PubMed ID: 26598453
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Pediatric exclusivity: evolving legislation and novel complexities within pediatric therapeutic development.
    Rivera DR; Hartzema AG
    Ann Pharmacother; 2014 Mar; 48(3):369-79. PubMed ID: 24311725
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Research misconduct identified by the US Food and Drug Administration: out of sight, out of mind, out of the peer-reviewed literature.
    Seife C
    JAMA Intern Med; 2015 Apr; 175(4):567-77. PubMed ID: 25664866
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Economic return of clinical trials performed under the pediatric exclusivity program.
    Li JS; Eisenstein EL; Grabowski HG; Reid ED; Mangum B; Schulman KA; Goldsmith JV; Murphy MD; Califf RM; Benjamin DK
    JAMA; 2007 Feb; 297(5):480-8. PubMed ID: 17284698
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Drug labeling and exposure in neonates.
    Laughon MM; Avant D; Tripathi N; Hornik CP; Cohen-Wolkowiez M; Clark RH; Smith PB; Rodriguez W
    JAMA Pediatr; 2014 Feb; 168(2):130-6. PubMed ID: 24322269
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Assessment of the Impact of Mandated Postmarketing Pediatric-Focused Safety Reviews on Safety-Related Regulatory Actions 2013-2019.
    Mohamoud M; Cheng C; Ryan D; Kim I; Wu E; Muñoz M; Kortepeter C; Pinnow E; Dal Pan G
    Clin Pharmacol Ther; 2023 Jun; 113(6):1368-1377. PubMed ID: 37021630
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Stimulation programs for pediatric drug research--do children really benefit?
    Boots I; Sukhai RN; Klein RH; Holl RA; Wit JM; Cohen AF; Burggraaf J
    Eur J Pediatr; 2007 Aug; 166(8):849-55. PubMed ID: 17225950
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Evaluation of FDA Labeling Changes Related to PREA Safety-Waivers.
    Krastein J; Pica-Branco D; Bacho MA; Mulugeta Y; Maynard JW; Alexander JJ; Yao L; Hausman ED
    Ther Innov Regul Sci; 2023 Sep; 57(5):1099-1103. PubMed ID: 37389793
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Safety monitoring of drugs receiving pediatric marketing exclusivity.
    Smith PB; Benjamin DK; Murphy MD; Johann-Liang R; Iyasu S; Gould B; Califf RM; Li JS; Rodriguez W
    Pediatrics; 2008 Sep; 122(3):e628-33. PubMed ID: 18762496
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Combined Pediatric and Adult Trials Submitted to the US Food and Drug Administration 2012-2018.
    Tanaudommongkon I; John Miyagi S; Green DJ; Burnham JM; van den Anker JN; Park K; Wu J; McCune SK; Yao L; Burckart GJ
    Clin Pharmacol Ther; 2020 Nov; 108(5):1018-1025. PubMed ID: 32394430
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Effects of the pharmaceutical technologic aspects of oral pediatric drugs on patient-related outcomes: a systematic literature review.
    van Riet-Nales DA; Schobben AF; Egberts TC; Rademaker CM
    Clin Ther; 2010 May; 32(5):924-38. PubMed ID: 20685501
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Reporting of clinical trial safety results in ClinicalTrials.gov for FDA-approved drugs: A cross-sectional analysis.
    Chen KY; Borglund EM; Postema EC; Dunn AG; Bourgeois FT
    Clin Trials; 2022 Aug; 19(4):442-451. PubMed ID: 35482320
    [TBL] [Abstract][Full Text] [Related]  

  • 19. IOM Review of FDA--approved biologics labeled or studied for pediatric use.
    Field MJ; Ellinger LK; Boat TF
    Pediatrics; 2013 Feb; 131(2):328-35. PubMed ID: 23319521
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Improving pediatric dosing through pediatric initiatives: what we have learned.
    Rodriguez W; Selen A; Avant D; Chaurasia C; Crescenzi T; Gieser G; Di Giacinto J; Huang SM; Lee P; Mathis L; Murphy D; Murphy S; Roberts R; Sachs HC; Suarez S; Tandon V; Uppoor RS
    Pediatrics; 2008 Mar; 121(3):530-9. PubMed ID: 18310202
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 10.