These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

206 related articles for article (PubMed ID: 24213186)

  • 1. Significant differences in drug lag in clinical development among various strategies used for regulatory submissions in Japan.
    Ueno T; Asahina Y; Tanaka A; Yamada H; Nakamura M; Uyama Y
    Clin Pharmacol Ther; 2014 May; 95(5):533-41. PubMed ID: 24213186
    [TBL] [Abstract][Full Text] [Related]  

  • 2. 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]  

  • 3. Recent trends and success factors in reducing the lag time to approval of new drugs in Japan.
    Honig PK
    Clin Pharmacol Ther; 2014 May; 95(5):467-9. PubMed ID: 24747231
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Approaches to Japanese dose evaluation in global drug development: factors that generate different dosages between Japan and the United States.
    Nakashima K; Narukawa M; Takeuchi M
    Clin Pharmacol Ther; 2011 Dec; 90(6):836-43. PubMed ID: 22048222
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Assessment of factors associated with dose differences between Japan and the United States.
    Arnold FL; Fukunaga S; Kusama M; Matsuki N; Ono S
    Clin Pharmacol Ther; 2014 May; 95(5):542-9. PubMed ID: 24281222
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Analysis of new drugs whose clinical development and regulatory approval were hampered during their introduction in Japan.
    Asada R; Shimizu S; Ono S; Ito T; Shimizu A; Yamaguchi T
    J Clin Pharm Ther; 2013 Aug; 38(4):309-13. PubMed ID: 23574352
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Multiregional clinical trials: Japanese perspective on drug development strategy and sample size for Japanese subjects.
    Ando Y; Uyama Y
    J Biopharm Stat; 2012 Sep; 22(5):977-87. PubMed ID: 22946944
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Relationship between drug lag and factors associated with clinical trials in Japan.
    Ohwaki K; Nakabayashi T
    J Clin Pharm Ther; 2014 Dec; 39(6):649-52. PubMed ID: 25200123
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Recent trends for drug lag in clinical development of oncology drugs in Japan: does the oncology drug lag still exist in Japan?
    Maeda H; Kurokawa T
    Int J Clin Oncol; 2015 Dec; 20(6):1072-80. PubMed ID: 25837976
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Regulatory challenges in the review of data from global clinical trials: the PMDA perspective.
    Asano K; Tanaka A; Sato T; Uyama Y
    Clin Pharmacol Ther; 2013 Aug; 94(2):195-8. PubMed ID: 23872835
    [TBL] [Abstract][Full Text] [Related]  

  • 11. New drug approval times and clinical evidence in Japan.
    Ono S; Yoshioka C; Asaka O; Tamura K; Shibata T; Saito K
    Contemp Clin Trials; 2005 Dec; 26(6):660-72. PubMed ID: 16122988
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Physiologically based pharmacokinetic modeling: from regulatory science to regulatory policy.
    Sinha V; Zhao P; Huang SM; Zineh I
    Clin Pharmacol Ther; 2014 May; 95(5):478-80. PubMed ID: 24747236
    [TBL] [Abstract][Full Text] [Related]  

  • 13. [Consideration of clinical development for new anticancer drugs on Japan, proposal from approval reviewer].
    Urano T
    Gan To Kagaku Ryoho; 2007 Feb; 34(2):305-7. PubMed ID: 17301550
    [TBL] [Abstract][Full Text] [Related]  

  • 14. PMDA's challenge to accelerate clinical development and review of new drugs in Japan.
    Ichimaru K; Toyoshima S; Uyama Y
    Clin Pharmacol Ther; 2010 Oct; 88(4):454-7. PubMed ID: 20856242
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Japanese regulatory system for approval of off-label drug use: evaluation of safety and effectiveness in literature-based applications.
    Shimazawa R; Ikeda M
    Clin Ther; 2012 Oct; 34(10):2104-16. PubMed ID: 23036337
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Evaluation of Drug Lags in Development Initiation, New Drug Application and Approval Between Japan and the USA and the Impact of Local Versus Multi-regional Clinical Trials.
    Ushijima S; Matsumaru N; Tsukamoto K
    Pharmaceut Med; 2021 Jul; 35(4):253-260. PubMed ID: 34291425
    [TBL] [Abstract][Full Text] [Related]  

  • 17. [Infrastructure for new drug development to treat muscular dystrophy: current status of patient registration (remudy)].
    Nakamura H; Kimura E; Kawai M
    Brain Nerve; 2011 Nov; 63(11):1279-84. PubMed ID: 22068481
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Efficient clinical trials in Japan: Bridging studies versus participation in global clinical trials.
    Shirotani M; Suwa T; Kurokawa T; Chiba K
    J Clin Pharmacol; 2014 Apr; 54(4):438-45. PubMed ID: 24165947
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Clinical development and review times for new drugs in Japan: associated factors.
    Ishibashi T; Yasuda K; Kusama M; Sugiyama Y; Ono S
    Clin Pharmacol Ther; 2010 Oct; 88(4):487-91. PubMed ID: 20739921
    [TBL] [Abstract][Full Text] [Related]  

  • 20. 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]  

    [Next]    [New Search]
    of 11.