BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

215 related articles for article (PubMed ID: 32394430)

  • 1. 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]  

  • 2. Pediatric drug information available at the time of new drug approvals: A cross-sectional analysis.
    Hudgins JD; Bacho MA; Olsen KL; Bourgeois FT
    Pharmacoepidemiol Drug Saf; 2018 Feb; 27(2):161-167. PubMed ID: 29148107
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Review of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act: What can the obstetric community learn from the pediatric experience?
    Ren Z; Zajicek A
    Semin Perinatol; 2015 Nov; 39(7):530-1. PubMed ID: 26455383
    [TBL] [Abstract][Full Text] [Related]  

  • 4. A review of the experience with pediatric written requests issued for oncology drug products.
    Akalu AY; Meng X; Reaman GH; Ma L; Yuan W; Ye J
    Pediatr Blood Cancer; 2021 Feb; 68(2):e28828. PubMed ID: 33245181
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Timing of Pediatric Drug Approval and Clinical Evidence Submitted to Regulatory Authorities: International Comparison Among Japan, the United States, and the European Union.
    Hirota S; Yamaguchi T
    Clin Pharmacol Ther; 2020 Nov; 108(5):985-994. PubMed ID: 31869436
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Drug labeling changes and pediatric hematology/oncology prescribing: Measuring the impact of U.S. legislation.
    Benning TJ; Shah ND; Inselman JW; Van Houten HK; Ross JS; Wyatt KD
    Clin Trials; 2021 Dec; 18(6):732-740. PubMed ID: 34269090
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Dermatology Drugs for Children-U.S. Food and Drug Administration Perspective.
    Epps RE
    Dermatol Clin; 2022 Jul; 40(3):289-296. PubMed ID: 35750412
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Inclusion of Infants and Neonates in Pediatric Orphan Product Approvals.
    Park K; Virparia R; Green DJ; Epps C; Wharton GT; McCune SK; Burckart GJ
    Clin Pharmacol Ther; 2021 Oct; 110(4):997-1003. PubMed ID: 34028811
    [TBL] [Abstract][Full Text] [Related]  

  • 9. 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]  

  • 10. Duration of Pediatric Clinical Trials Submitted to the US Food and Drug Administration.
    Zimmerman KO; Smith PB; McMahon AW; Temeck J; Avant D; Murphy D; McCune S
    JAMA Pediatr; 2019 Jan; 173(1):60-67. PubMed ID: 30452504
    [TBL] [Abstract][Full Text] [Related]  

  • 11. 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]  

  • 12. 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]  

  • 13. Pediatric Antibacterial and Antifungal Trials From 2007 to 2017.
    Thaden JT; Chiswell K; Jaffe I; Bergin SP; Yang WE; Romaine A; Roberts J; Nambiar S; Farley J; Benjamin DK; Smith PB; Tsalik EL
    Pediatrics; 2018 Sep; 142(3):. PubMed ID: 30158197
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Clinical trial considerations for pediatric cancer drug development.
    Cooner F; Ye J; Reaman G
    J Biopharm Stat; 2023 Nov; 33(6):859-874. PubMed ID: 36749066
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Adolescent dosing and labeling since the Food and Drug Administration Amendments Act of 2007.
    Momper JD; Mulugeta Y; Green DJ; Karesh A; Krudys KM; Sachs HC; Yao LP; Burckart GJ
    JAMA Pediatr; 2013 Oct; 167(10):926-32. PubMed ID: 23921678
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Patient-Reported Outcomes Labeling for Products Approved by the Office of Hematology and Oncology Products of the US Food and Drug Administration (2010-2014).
    Gnanasakthy A; DeMuro C; Clark M; Haydysch E; Ma E; Bonthapally V
    J Clin Oncol; 2016 Jun; 34(16):1928-34. PubMed ID: 27069082
    [TBL] [Abstract][Full Text] [Related]  

  • 17. 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]  

  • 18. Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review.
    Wang B; Kesselheim AS
    BMJ; 2015 Sep; 351():h4679. PubMed ID: 26400844
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Incentivizing Orphan Product Development: United States Food and Drug Administration Orphan Incentive Programs.
    Le TT
    Adv Exp Med Biol; 2017; 1031():183-196. PubMed ID: 29214572
    [TBL] [Abstract][Full Text] [Related]  

  • 20. What the Orphan Drug Act has done lately for children with rare diseases: a 10-year analysis.
    Thorat C; Xu K; Freeman SN; Bonnel RA; Joseph F; Phillips MI; Imoisili MA
    Pediatrics; 2012 Mar; 129(3):516-21. PubMed ID: 22371464
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 11.