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 *

111 related articles for article (PubMed ID: 23702264)

  • 1. Consistency assessment with global and bridging development strategies in emerging markets.
    Li G; Chen J; Quan H; Shentu Y
    Contemp Clin Trials; 2013 Nov; 36(2):687-96. PubMed ID: 23702264
    [TBL] [Abstract][Full Text] [Related]  

  • 2. New paradigm for drug developments--from emerging market statistical perspective.
    Quan H; Chen X; Zhang J; Zhao PL
    Contemp Clin Trials; 2013 Nov; 36(2):697-703. PubMed ID: 23810938
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Establishing consistency across all regions in a multi-regional clinical trial.
    Tsou HH; James Hung HM; Chen YM; Huang WS; Chang WJ; Hsiao CF
    Pharm Stat; 2012; 11(4):295-9. PubMed ID: 22504851
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Clinical trials in "emerging markets": regulatory considerations and other factors.
    Singh R; Wang O
    Contemp Clin Trials; 2013 Nov; 36(2):711-8. PubMed ID: 24070788
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Unified additional requirement in consideration of regional approval for multiregional clinical trials.
    Teng Z; Chen YF; Chang M
    J Biopharm Stat; 2017; 27(6):903-917. PubMed ID: 28287339
    [TBL] [Abstract][Full Text] [Related]  

  • 6. [Contact and dialogue between drug companies and the global regulatory authorities throughout research and development phase].
    Kock M; Thomsen MK
    Ugeskr Laeger; 2003 Apr; 165(16):1649-52. PubMed ID: 12756820
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Sample size determination for a specific region in a multiregional trial.
    Ko FS; Tsou HH; Liu JP; Hsiao CF
    J Biopharm Stat; 2010 Jul; 20(4):870-85. PubMed ID: 20496211
    [TBL] [Abstract][Full Text] [Related]  

  • 8. A consistency approach to evaluation of bridging studies and multi-regional trials.
    Tsou HH; Chien TY; Liu JP; Hsiao CF
    Stat Med; 2011 Jul; 30(17):2171-86. PubMed ID: 21590701
    [TBL] [Abstract][Full Text] [Related]  

  • 9. A predictive Bayesian approach to the design and analysis of bridging studies.
    Gould AL; Jin T; Zhang LX; Wang WW
    J Biopharm Stat; 2012 Sep; 22(5):916-34. PubMed ID: 22946940
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Statistical design of noninferiority multiple region clinical trials to assess global and consistent treatment effects.
    Diao G; Zeng D; Ibrahim JG; Rong A; Lee O; Zhang K; Chen Q
    J Biopharm Stat; 2017; 27(6):933-944. PubMed ID: 28296570
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Clinical trials for drug registrations in Asian-Pacific countries: proposal for a new paradigm from a statistical perspective.
    Shih WJ
    Control Clin Trials; 2001 Aug; 22(4):357-66. PubMed ID: 11514037
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Reproducibility probability in clinical trials.
    Shao J; Chow SC
    Stat Med; 2002 Jun; 21(12):1727-42. PubMed ID: 12111908
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Graphical assessment of consistency in treatment effect among countries in multi-regional clinical trials.
    Chen J; Zheng H; Quan H; Li G; Gallo P; Ouyang SP; Binkowitz B; Ting N; Tanaka Y; Luo X; Ibia E;
    Clin Trials; 2013; 10(6):842-51. PubMed ID: 24013404
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Policy developments in regulatory approval.
    Temple R
    Stat Med; 2002 Oct; 21(19):2939-48. PubMed ID: 12325110
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Challenges in the clinical development requirements for the marketing authorization of new medicines in southeast Asia.
    Kudrin A
    J Clin Pharmacol; 2009 Mar; 49(3):268-80. PubMed ID: 19168433
    [TBL] [Abstract][Full Text] [Related]  

  • 16. 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]  

  • 17. Lack of compliance of European Public Assessment Reports to guidelines for paediatric drug development before the introduction of paediatric investigation plans.
    Piana C; Kliphuis E; Della Pasqua O
    Clin Trials; 2013 Apr; 10(2):269-79. PubMed ID: 23335676
    [TBL] [Abstract][Full Text] [Related]  

  • 18. An empirical Bayes approach to evaluation of results for a specific region in multiregional clinical trials.
    Huang Y; Chang WJ; Hsiao CF
    Pharm Stat; 2013; 12(2):59-64. PubMed ID: 23319408
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Determining optimal sample sizes for multistage adaptive randomized clinical trials from an industry perspective using value of information methods.
    Chen MH; Willan AR
    Clin Trials; 2013 Feb; 10(1):54-62. PubMed ID: 23263520
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Optimal sample size determinations from an industry perspective based on the expected value of information.
    Willan AR
    Clin Trials; 2008; 5(6):587-94. PubMed ID: 19029207
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 6.