BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

146 related articles for article (PubMed ID: 36749066)

  • 1. 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]  

  • 2. The RACE for children act at one year: progress in pediatric development of molecularly targeted oncology drugs.
    Zettler ME
    Expert Rev Anticancer Ther; 2022 Mar; 22(3):317-321. PubMed ID: 35051348
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Paediatric Strategy Forum for medicinal product development of epigenetic modifiers for children: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.
    Pearson AD; Stegmaier K; Bourdeaut F; Reaman G; Heenen D; Meyers ML; Armstrong SA; Brown P; De Carvalho D; Jabado N; Marshall L; Rivera M; Smith M; Adamson PC; Barone A; Baumann C; Blackman S; Buenger V; Donoghue M; Duncan AD; Fox E; Gadbaw B; Hattersley M; Ho P; Jacobs I; Kelly MJ; Kieran M; Lesa G; Ligas F; Ludwinski D; McDonough J; Nikolova Z; Norga K; Senderowicz A; Taube T; Weiner S; Karres D; Vassal G
    Eur J Cancer; 2020 Nov; 139():135-148. PubMed ID: 32992153
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Pediatric Trials for Cancer Therapies With Targets Potentially Relevant to Pediatric Cancers.
    Hwang TJ; Orenstein L; DuBois SG; Janeway KA; Bourgeois FT
    J Natl Cancer Inst; 2020 Mar; 112(3):224-228. PubMed ID: 31665394
    [TBL] [Abstract][Full Text] [Related]  

  • 5. 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]  

  • 6. 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]  

  • 7. Application of orphan drug designation to cancer treatments (2008-2017): a comprehensive and comparative analysis of the USA and EU.
    Vokinger KN; Kesselheim AS
    BMJ Open; 2019 Oct; 9(10):e028634. PubMed ID: 31601584
    [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. Navigating the Regulatory Landscape to Develop Pediatric Oncology Drugs: Expert Opinion Recommendations.
    Barry E; Walsh JA; Weinrich SL; Beaupre D; Blasi E; Arenson DR; Jacobs IA
    Paediatr Drugs; 2021 Jul; 23(4):381-394. PubMed ID: 34173206
    [TBL] [Abstract][Full Text] [Related]  

  • 10. An overview of cancer drugs approved through expedited approval programs and orphan medicine designation globally between 2011 and 2020.
    Wang S; Yang Q; Deng L; Lei Q; Yang Y; Ma P; Men Y; Yung BC; Lee RJ; Zhang M; Li N
    Drug Discov Today; 2022 May; 27(5):1236-1250. PubMed ID: 34971818
    [TBL] [Abstract][Full Text] [Related]  

  • 11. 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]  

  • 12. Using four decades of FDA orphan drug designations to describe trends in rare disease drug development: substantial growth seen in development of drugs for rare oncologic, neurologic, and pediatric-onset diseases.
    Miller KL; Fermaglich LJ; Maynard J
    Orphanet J Rare Dis; 2021 Jun; 16(1):265. PubMed ID: 34107994
    [TBL] [Abstract][Full Text] [Related]  

  • 13. 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]  

  • 14. 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]  

  • 15. FDA approval, clinical trial evidence, efficacy, epidemiology, and price for non-orphan and ultra-rare, rare, and common orphan cancer drug indications: cross sectional analysis.
    Michaeli T; Jürges H; Michaeli DT
    BMJ; 2023 May; 381():e073242. PubMed ID: 37160306
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Accelerated approval of cancer drugs: improved access to therapeutic breakthroughs or early release of unsafe and ineffective drugs?
    Richey EA; Lyons EA; Nebeker JR; Shankaran V; McKoy JM; Luu TH; Nonzee N; Trifilio S; Sartor O; Benson AB; Carson KR; Edwards BJ; Gilchrist-Scott D; Kuzel TM; Raisch DW; Tallman MS; West DP; Hirschfeld S; Grillo-Lopez AJ; Bennett CL
    J Clin Oncol; 2009 Sep; 27(26):4398-405. PubMed ID: 19636013
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Cancer drugs approved for use in children: Impact of legislative initiatives and future opportunities.
    Barone A; Casey D; McKee AE; Reaman G
    Pediatr Blood Cancer; 2019 Aug; 66(8):e27809. PubMed ID: 31144772
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Analysis of orphan designation status for FDA approved drugs, and case studies in oncology, neuroscience and metabolic diseases.
    Brown DG; Wobst HJ
    Bioorg Med Chem; 2023 Feb; 80():117170. PubMed ID: 36696875
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer.
    Kesselheim AS; Myers JA; Avorn J
    JAMA; 2011 Jun; 305(22):2320-6. PubMed ID: 21642684
    [TBL] [Abstract][Full Text] [Related]  

  • 20. FDA orphan products clinical trial grants: assessment of outcomes and impact on rare disease product development.
    Miller KL; Mueller C; Liu G; Miller Needleman KI; Maynard J
    Orphanet J Rare Dis; 2020 Sep; 15(1):234. PubMed ID: 32883327
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 8.