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 *

324 related articles for article (PubMed ID: 21807534)

  • 1. Statistical considerations for confirmatory clinical trials for similar biotherapeutic products.
    Njue C
    Biologicals; 2011 Sep; 39(5):266-9. PubMed ID: 21807534
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Biosimilars clinical development program: confirmatory clinical trials: a virtual/simulated case study comparing equivalence and non-inferiority approaches.
    Fletcher MP
    Biologicals; 2011 Sep; 39(5):270-7. PubMed ID: 21875812
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Summary of the diverse situation of similar biotherapeutic products in the selected countries (August 2010).
    Kang HN
    Biologicals; 2011 Sep; 39(5):304-7. PubMed ID: 21880507
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Issues on the selection of non-inferiority margin in clinical trials.
    Hou Y; Wu XY; Li K
    Chin Med J (Engl); 2009 Feb; 122(4):466-70. PubMed ID: 19302756
    [TBL] [Abstract][Full Text] [Related]  

  • 5. [Methodological and statistical aspects of equivalence and non inferiority trials].
    Elie C; De Rycke Y; Jais JP; Marion-Gallois R; Landais P
    Rev Epidemiol Sante Publique; 2008 Aug; 56(4):267-77. PubMed ID: 18703296
    [TBL] [Abstract][Full Text] [Related]  

  • 6. On non-inferiority margin and statistical tests in active control trials.
    Chow SC; Shao J
    Stat Med; 2006 Apr; 25(7):1101-13. PubMed ID: 16345042
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Clinical programs in the development of similar biotherapeutic products: rationale and general principles.
    Berghout A
    Biologicals; 2011 Sep; 39(5):293-6. PubMed ID: 21911300
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Stability of vaccines - bridging from stability data to continuous safety and efficacy throughout shelf life - an always reliable approach?
    Pfleiderer M
    Biologicals; 2009 Nov; 37(6):364-8. PubMed ID: 19773184
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Statistical considerations in biosimilar clinical efficacy trials with asymmetrical margins.
    Li Y; Liu Q; Wood P; Johri A
    Stat Med; 2013 Feb; 32(3):393-405. PubMed ID: 22991275
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Evaluation of similar biotherapeutic products (SBPs): scientific principles and their implementation.
    Knezevic I
    Biologicals; 2011 Sep; 39(5):256-61. PubMed ID: 21907589
    [TBL] [Abstract][Full Text] [Related]  

  • 11. [Statistical notes. From superiority to non-inferiority clinical trials: a leap in the dark?].
    Marubini E; Rebora P; Reina G
    Ital Heart J Suppl; 2004 Sep; 5(9):712-9. PubMed ID: 15568609
    [TBL] [Abstract][Full Text] [Related]  

  • 12. WHO/KFDA joint workshop on implementing WHO guidelines on evaluating similar biotherapeutic products, Seoul, Republic of Korea 24-26 August, 2010.
    Wadhwa M; Kang HN; Knezevic I; Thorpe R; Griffiths E
    Biologicals; 2011 Sep; 39(5):349-57. PubMed ID: 21906959
    [TBL] [Abstract][Full Text] [Related]  

  • 13. A note on the conservativeness of the confidence interval approach for the selection of non-inferiority margin in the two-arm active-control trial.
    Sankoh AJ
    Stat Med; 2008 Aug; 27(19):3732-42. PubMed ID: 18407575
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Non-inferiority trials: design concepts and issues - the encounters of academic consultants in statistics.
    D'Agostino RB; Massaro JM; Sullivan LM
    Stat Med; 2003 Jan; 22(2):169-86. PubMed ID: 12520555
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Non-inferiority trials: the 'at least as good as' criterion with dichotomous data.
    Laster LL; Johnson MF; Kotler ML
    Stat Med; 2006 Apr; 25(7):1115-30. PubMed ID: 16381070
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Design, operation, and interpretation of clinical trials.
    Pihlstrom BL; Barnett ML
    J Dent Res; 2010 Aug; 89(8):759-72. PubMed ID: 20581353
    [TBL] [Abstract][Full Text] [Related]  

  • 17. ['Non-inferiority' trials. Tips for the critical reader. Research methodology 3].
    Soonawala D; Dekkers OM
    Ned Tijdschr Geneeskd; 2012; 156(19):A4665. PubMed ID: 22571548
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Current issues in non-inferiority trials.
    Fleming TR
    Stat Med; 2008 Feb; 27(3):317-32. PubMed ID: 17340597
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Current development in regulation of similar biotherapeutic products in Brazil.
    Castanheira LG; Barbano DB; Rech N
    Biologicals; 2011 Sep; 39(5):308-11. PubMed ID: 21868247
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Rank-based tests for non-inferiority and equivalence hypotheses in multi-centre clinical trials using mixed models.
    Rashid MM
    Stat Med; 2003 Jan; 22(2):291-311. PubMed ID: 12520563
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 17.