BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

186 related articles for article (PubMed ID: 29732928)

  • 21. The Potential Benefit of Expedited Development and Approval Programs in Precision Medicine.
    Kantor A; Haga SB
    J Pers Med; 2021 Jan; 11(1):. PubMed ID: 33466644
    [TBL] [Abstract][Full Text] [Related]  

  • 22. Assessment of the breakthrough-therapy-designated drugs granted in China: A pooled analysis 2020-2022.
    Luo X; Qian F; Yang L; Li Y; Yang Y
    Drug Discov Today; 2022 Dec; 27(12):103370. PubMed ID: 36154876
    [TBL] [Abstract][Full Text] [Related]  

  • 23. Anticancer drug development from traditional cytotoxic to targeted therapies: evidence of shorter drug research and development time, and shorter drug lag in Japan.
    Kawabata-Shoda E; Masuda S; Kimura H
    J Clin Pharm Ther; 2012 Oct; 37(5):547-52. PubMed ID: 22428857
    [TBL] [Abstract][Full Text] [Related]  

  • 24. Decisions on Non-oncology Breakthrough Therapy Designation Requests in 2017-2019.
    Poddar A; Raggio M; Concato J
    Ther Innov Regul Sci; 2024 Jan; 58(1):214-221. PubMed ID: 37926768
    [TBL] [Abstract][Full Text] [Related]  

  • 25. Characteristics of drugs approved in Japan without conducting confirmatory clinical trials.
    Izuka S; Matsumaru N; Tsukamoto K
    J Clin Pharm Ther; 2021 Dec; 46(6):1582-1590. PubMed ID: 34250620
    [TBL] [Abstract][Full Text] [Related]  

  • 26. The FDA Oncology Center of Excellence and precision medicine.
    Goldberg KB; Blumenthal GM; McKee AE; Pazdur R
    Exp Biol Med (Maywood); 2018 Feb; 243(3):308-312. PubMed ID: 29105511
    [TBL] [Abstract][Full Text] [Related]  

  • 27. A Drug Discovery Perspective on FDA Expedited Development and Incentive Programs.
    Brown DG
    J Med Chem; 2024 Feb; 67(3):1690-1700. PubMed ID: 38233132
    [TBL] [Abstract][Full Text] [Related]  

  • 28. Overview of Oncology and Hematology Drug Approvals at US Food and Drug Administration Between 2008 and 2016.
    Zhou J; Vallejo J; Kluetz P; Pazdur R; Kim T; Keegan P; Farrell A; Beaver JA; Sridhara R
    J Natl Cancer Inst; 2019 May; 111(5):449-458. PubMed ID: 30085269
    [TBL] [Abstract][Full Text] [Related]  

  • 29. Co-Development of Oncology Drugs and Companion Diagnostics: Analyses of Approval Lags and Drug Development Periods in Recently Approved Cases in Japan.
    Tanaka A; Suzuki H; Toyoshima S; Nagai N
    Ther Innov Regul Sci; 2022 Jan; 56(1):85-95. PubMed ID: 34406635
    [TBL] [Abstract][Full Text] [Related]  

  • 30. The US Food and Drug Administration's expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements.
    Wallach JD; Ross JS; Naci H
    Clin Trials; 2018 Jun; 15(3):219-229. PubMed ID: 29871509
    [TBL] [Abstract][Full Text] [Related]  

  • 31. Development of drug-approval regulations for medical countermeasures against CBRN agents in Japan.
    Shimazawa R; Ikeda M
    Health Secur; 2015; 13(2):130-8. PubMed ID: 25813978
    [TBL] [Abstract][Full Text] [Related]  

  • 32. Regulatory approval characteristics of antimicrobial versus non-antimicrobial products, 1984-2018: an evaluation of Food and Drug Administration flexibilities.
    Darrow JJ; Najafzadeh M; Stefanini K; Kesselheim AS
    Lancet Infect Dis; 2020 Jul; 20(7):e159-e164. PubMed ID: 32502431
    [TBL] [Abstract][Full Text] [Related]  

  • 33. The notorious "drug lag" for oncology drugs in Japan.
    Yonemori K; Hirakawa A; Ando M; Hirata T; Yunokawa M; Shimizu C; Katsumata N; Tamura K; Fujiwara Y
    Invest New Drugs; 2011 Aug; 29(4):706-12. PubMed ID: 21286780
    [TBL] [Abstract][Full Text] [Related]  

  • 34. Breakthrough Therapy Designation: CDER Analysis of Requests 4 Years Into the Program.
    Conrad R; Taylor K; Raggio M; Harrington A; Stark G; Kish A; Bertha A
    Ther Innov Regul Sci; 2017 Jul; 51(4):509-515. PubMed ID: 30227048
    [TBL] [Abstract][Full Text] [Related]  

  • 35. FDA designations for therapeutics and their impact on drug development and regulatory review outcomes.
    Kesselheim AS; Darrow JJ
    Clin Pharmacol Ther; 2015 Jan; 97(1):29-36. PubMed ID: 25670381
    [TBL] [Abstract][Full Text] [Related]  

  • 36. A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making.
    Coppens DGM; de Wilde S; Guchelaar HJ; De Bruin ML; Leufkens HGM; Meij P; Hoekman J
    Cytotherapy; 2018 Jun; 20(6):769-778. PubMed ID: 29730080
    [TBL] [Abstract][Full Text] [Related]  

  • 37. Factors That Influence FDA Decisions for Postmarketing Requirements and Commitments During Review of Oncology Products.
    Hyogo A; Kaneko M; Narukawa M
    J Oncol Pract; 2018 Jan; 14(1):e34-e41. PubMed ID: 29136389
    [TBL] [Abstract][Full Text] [Related]  

  • 38. Oncology drug lag in Japan: has it improved over the last decade?
    Tachibana Y; Narukawa M
    Int J Clin Oncol; 2023 Nov; 28(11):1451-1460. PubMed ID: 37561368
    [TBL] [Abstract][Full Text] [Related]  

  • 39. Exploratory Analysis of Drug Lag in New Oncology Drugs Between Japan and the US.
    Maki A; Narukawa M
    Ther Innov Regul Sci; 2023 Jul; 57(4):671-677. PubMed ID: 36966205
    [TBL] [Abstract][Full Text] [Related]  

  • 40. Assessment of Surrogate End Point Trends in Clinical Trials to Approve Oncology Drugs From 2001 to 2020 in Japan.
    Maeda H; Shingai R; Takeda K; Hara A; Murai Y; Ofuchi M
    JAMA Netw Open; 2023 Apr; 6(4):e238875. PubMed ID: 37115550
    [TBL] [Abstract][Full Text] [Related]  

    [Previous]   [Next]    [New Search]
    of 10.