BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

511 related articles for article (PubMed ID: 20077246)

  • 1. Statistical assessment of biosimilar products.
    Chow SC; Liu JP
    J Biopharm Stat; 2010 Jan; 20(1):10-30. PubMed ID: 20077246
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Application of the parallel line assay to assessment of biosimilar products based on binary endpoints.
    Lin JR; Chow SC; Chang CH; Lin YC; Liu JP
    Stat Med; 2013 Feb; 32(3):449-61. PubMed ID: 22911920
    [TBL] [Abstract][Full Text] [Related]  

  • 3. A consistency approach for evaluation of biosimilar products.
    Tsou HH; Chang WJ; Hwang WS; Lai YH
    J Biopharm Stat; 2013; 23(5):1054-66. PubMed ID: 23957515
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Biosimilars: current status and future directions.
    Roger SD
    Expert Opin Biol Ther; 2010 Jul; 10(7):1011-8. PubMed ID: 20384525
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Follow-on biologics: challenges of the "next generation".
    Schellekens H
    Nephrol Dial Transplant; 2005 May; 20 Suppl 4():iv31-36. PubMed ID: 15827057
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Biosimilars: how similar or dissimilar are they?
    Roger SD
    Nephrology (Carlton); 2006 Aug; 11(4):341-6. PubMed ID: 16889575
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Statistical methods for assessment of biosimilarity using biomarker data.
    Chow SC; Lu Q; Tse SK; Chi E
    J Biopharm Stat; 2010 Jan; 20(1):90-105. PubMed ID: 20077251
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Similar biological medicinal products containing recombinant human growth hormone: European regulation.
    Pavlovic M; Girardin E; Kapetanovic L; Ho K; Trouvin JH
    Horm Res; 2008; 69(1):14-21. PubMed ID: 18059081
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Scientific considerations for assessing biosimilar products.
    Chow SC; Wang J; Endrenyi L; Lachenbruch PA
    Stat Med; 2013 Feb; 32(3):370-81. PubMed ID: 22933240
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Differentiating low-molecular-weight heparins based on chemical, biological, and pharmacologic properties: implications for the development of generic versions of low-molecular-weight heparins.
    Jeske WP; Walenga JM; Hoppensteadt DA; Vandenberg C; Brubaker A; Adiguzel C; Bakhos M; Fareed J
    Semin Thromb Hemost; 2008 Feb; 34(1):74-85. PubMed ID: 18393144
    [TBL] [Abstract][Full Text] [Related]  

  • 11. A comparison of moment-based and probability-based criteria for assessment of follow-on biologics.
    Chow SC; Hsieh TC; Chi E; Yang J
    J Biopharm Stat; 2010 Jan; 20(1):31-45. PubMed ID: 20077247
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Generic low-molecular-weight heparins: some practical considerations.
    Fareed J; Leong WL; Hoppensteadt DA; Jeske WP; Walenga J; Wahi R; Bick RL
    Semin Thromb Hemost; 2004 Dec; 30(6):703-13. PubMed ID: 15630677
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Biosimilar medicines--new challenges for a new class of medicine.
    Fox A
    J Biopharm Stat; 2010 Jan; 20(1):3-9. PubMed ID: 20077245
    [TBL] [Abstract][Full Text] [Related]  

  • 14. The scope and requirements related to preclinical and clinical studies of a new medicinal product, including biotechnological and biosimilar products.
    Brodniewicz-Proba T
    Acta Pol Pharm; 2008; 65(6):641-5. PubMed ID: 19172845
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Biosimilars approval process.
    Zuñiga L; Calvo B
    Regul Toxicol Pharmacol; 2010 Apr; 56(3):374-7. PubMed ID: 19925842
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Biosimilars: pharmacovigilance and risk management.
    Zuñiga L; Calvo B
    Pharmacoepidemiol Drug Saf; 2010 Jul; 19(7):661-9. PubMed ID: 20583204
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Non-clinical safety studies on biosimilar recombinant human erythropoietin.
    Parnham MJ; Schindler-Horvat J; Kozlović M
    Basic Clin Pharmacol Toxicol; 2007 Feb; 100(2):73-83. PubMed ID: 17244255
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Implementation of the biosimilar pathway: economic and policy issues.
    Grabowski H; Long G; Mortimer R
    Seton Hall Law Rev; 2011; 41(2):511-57. PubMed ID: 21739758
    [No Abstract]   [Full Text] [Related]  

  • 19. Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration.
    Davit BM; Nwakama PE; Buehler GJ; Conner DP; Haidar SH; Patel DT; Yang Y; Yu LX; Woodcock J
    Ann Pharmacother; 2009 Oct; 43(10):1583-97. PubMed ID: 19776300
    [TBL] [Abstract][Full Text] [Related]  

  • 20. United States Food and Drug Administration requirements for approval of generic drug products.
    Meyer MC
    J Clin Psychiatry; 2001; 62 Suppl 5():4-9; discussion 23-4. PubMed ID: 11305846
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 26.