BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

380 related articles for article (PubMed ID: 20848767)

  • 1. Approval of new drugs 1999-2007: comparison of the US, the EU and Japan situations.
    Tsuji K; Tsutani K
    J Clin Pharm Ther; 2010 Jun; 35(3):289-301. PubMed ID: 20848767
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Approval of new biopharmaceuticals 1999-2006: comparison of the US, EU and Japan situations.
    Tsuji K; Tsutani K
    Eur J Pharm Biopharm; 2008 Mar; 68(3):496-502. PubMed ID: 17884403
    [TBL] [Abstract][Full Text] [Related]  

  • 3. 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]  

  • 4. An evaluation of drug lag for new drugs approved by the Indian regulator relative to the United States, European Union, and Japanese regulatory agencies: A 15-year analysis (2004-2018).
    Konwar M; Maurya MR; Nishandar TB; Thatte UM; Gogtay NJ
    Perspect Clin Res; 2021; 12(3):159-164. PubMed ID: 34386381
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Drug lag for cardiovascular drug approvals in India compared with the US and EU approvals.
    Kataria BC; Mehta DS; Chhaiya SB
    Indian Heart J; 2013; 65(1):24-9. PubMed ID: 23438609
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Analysis of Pediatric Drug Approval Lag in Japan.
    Ueyama E; Kaneko M; Narukawa M
    Ther Innov Regul Sci; 2021 Mar; 55(2):336-345. PubMed ID: 32959206
    [TBL] [Abstract][Full Text] [Related]  

  • 7. [Investigation on new molecular entities of drugs approved in three regions, Japan, U.S. and EU--common and preceding approvals in current 4 years].
    Saito M; Hirata-Koizumi M; Miyake S; Hasegawa R
    Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku; 2006; (124):80-2. PubMed ID: 17405529
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis.
    Tanaka M; Idei M; Sakaguchi H; Kato R; Sato D; Sawanobori K; Kawarasaki S; Hata T; Yoshizaki A; Nakamura M; Ikuma M
    Clin Pharmacol Ther; 2021 May; 109(5):1265-1273. PubMed ID: 33048367
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Regional Disparity in First-in-Class Anticancer Drug Development in the US, EU, and Japan.
    Hino Y; Okada M; Hallgreen CE; De Bruin ML; Doty RE; Matsumaru N; Tsukamoto K
    Biol Pharm Bull; 2023 May; 46(5):700-706. PubMed ID: 36878610
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Notable Differences in Drug Lag Between Korea and Japan of New Drugs Between 2009 and 2017.
    Lee SW; Park SH; Song I; Noh Y; Park H; Ha D; Shin JY
    Ther Innov Regul Sci; 2020 Mar; 54(2):418-423. PubMed ID: 32072585
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Clinical trial designs to obtain marketing authorization of drugs for haematological malignancy in Japan, the EU and the US.
    Nagai S; Ozawa K
    Br J Haematol; 2016 Jul; 174(2):249-54. PubMed ID: 27018163
    [TBL] [Abstract][Full Text] [Related]  

  • 12. The drug lag and associated factors for orphan anticancer drugs in Japan compared to the United States.
    Nakayama H; Matsumaru N; Tsukamoto K
    Invest New Drugs; 2019 Oct; 37(5):1086-1093. PubMed ID: 29855823
    [TBL] [Abstract][Full Text] [Related]  

  • 13. 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]  

  • 14. [Pediatric drug development: ICH harmonized tripartite guideline E11 within the United States of America, the European Union, and Japan].
    Pflieger M; Bertram D
    Arch Pediatr; 2014 Oct; 21(10):1129-38. PubMed ID: 25175054
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Potential Future Drug Development Lag in Japan Based on an Analysis of Multiregional Clinical Trials in the US, Europe, and East Asia.
    Noguchi A; Hanaoka H; Uyama Y
    Ther Innov Regul Sci; 2022 May; 56(3):523-529. PubMed ID: 35181842
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Biopharmaceuticals approved in the EU 1995-1999: a European Union-United States comparison.
    Reichert JM; Healy EM
    Eur J Pharm Biopharm; 2001 Jan; 51(1):1-7. PubMed ID: 11154897
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Delays in new drug applications in Japan and industrial R&D strategies.
    Hirai Y; Kinoshita H; Kusama M; Yasuda K; Sugiyama Y; Ono S
    Clin Pharmacol Ther; 2010 Feb; 87(2):212-8. PubMed ID: 19940847
    [TBL] [Abstract][Full Text] [Related]  

  • 18. 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]  

  • 19. Comparative Assessment of Drug Lag for Approved Oncology Targeted Therapies Between Saudi Arabia, the United States, and the European Union.
    Alnuhait M; Alshammari A; Alharbi M; AlOtaibi L; Alharbi R; Khobrani A; Alkhudair N; Alshamrani M; Alrajhi AM
    Ther Innov Regul Sci; 2024 Jul; 58(4):678-686. PubMed ID: 38536660
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Comparison of regulatory pathways for the approval of advanced therapies in the European Union and the United States.
    Iglesias-Lopez C; Obach M; Vallano A; Agustí A
    Cytotherapy; 2021 Mar; 23(3):261-274. PubMed ID: 33483292
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 19.