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 *

109 related articles for article (PubMed ID: 21917473)

  • 1. Experience of reviewing the follow-on biologics including Somatropin and erythropoietin in Japan.
    Arato T; Yamaguchi T
    Biologicals; 2011 Sep; 39(5):289-92. PubMed ID: 21917473
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Quality, safety and efficacy of follow-on biologics in Japan.
    Yamaguchi T; Arato T
    Biologicals; 2011 Sep; 39(5):328-32. PubMed ID: 21890377
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Biosimilars: impact of biologic product life cycle and European experience on the regulatory trajectory in the United States.
    Ahmed I; Kaspar B; Sharma U
    Clin Ther; 2012 Feb; 34(2):400-19. PubMed ID: 22244050
    [TBL] [Abstract][Full Text] [Related]  

  • 4. 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]  

  • 5. National cooperative rHu erythropoietin study in patients with chronic renal failure: a phase IV multicenter study. Report of National Cooperative rHu Erythropoietin Study Group.
    Nissenson AR
    Am J Kidney Dis; 1991 Oct; 18(4 Suppl 1):24-33. PubMed ID: 1928075
    [TBL] [Abstract][Full Text] [Related]  

  • 6. 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]  

  • 7. Concept of biosimilar products in Jordan.
    Haddadin RD
    Biologicals; 2011 Sep; 39(5):333-5. PubMed ID: 21873079
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Legislative initiatives in Europe, Canada and the US for market authorization of follow-on biologics.
    Looper YJ
    Curr Opin Drug Discov Devel; 2010 Mar; 13(2):247-56. PubMed ID: 20205058
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Recommendations regarding technical standards for follow-on biologics: comparability, similarity, interchangeability.
    Davis GC; Beals JM; Johnson C; Mayer MH; Meiklejohn BI; Mitlak BH; Roth JL; Towns JK; Veenhuizen M
    Curr Med Res Opin; 2009 Jul; 25(7):1655-61. PubMed ID: 19476407
    [TBL] [Abstract][Full Text] [Related]  

  • 10. 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]  

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

  • 12. Regulatory guideline for biosimilar products in Korea.
    Suh SK; Park Y
    Biologicals; 2011 Sep; 39(5):336-8. PubMed ID: 21784653
    [TBL] [Abstract][Full Text] [Related]  

  • 13. 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]  

  • 14. Biosimilar epoetins and other "follow-on" biologics: update on the European experiences.
    Jelkmann W
    Am J Hematol; 2010 Oct; 85(10):771-80. PubMed ID: 20706990
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Safety and effectiveness of a somatropin biosimilar in children requiring growth hormone treatment: second analysis of the PATRO Children study Italian cohort.
    Iughetti L; Antoniazzi F; Giavoli C; Bona G; Aversa T; Greggio NA; Guazzarotti L; Minelli R; Perrone L; Persani L; Pozzobon G; Ragusa L; Stagi S; Tornese G; Zecchino C; Gallinari P; Zouater H; Fedeli P; Zucchini S
    J Endocrinol Invest; 2021 Mar; 44(3):493-503. PubMed ID: 32557273
    [TBL] [Abstract][Full Text] [Related]  

  • 16. The first subsequent entry biologic authorized for market in Canada: the story of Omnitrope, a recombinant human growth hormone.
    Klein AV
    Biologicals; 2011 Sep; 39(5):278-81. PubMed ID: 21783382
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Reviewing non clinical data for a granulocyte colony stimulatory factor product: experience in Brazil.
    Castanheira LG
    Biologicals; 2011 Sep; 39(5):282-3. PubMed ID: 21784651
    [TBL] [Abstract][Full Text] [Related]  

  • 18. 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]  

  • 19. Similar biological medicinal products currently licensed in the European union--overview of non-clinical study programs.
    Heim HK
    Biologicals; 2011 Sep; 39(5):284-8. PubMed ID: 21871818
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Recombinant human erythropoietin.
    Jones EH
    Am J Hosp Pharm; 1989 Nov; 46(11 Suppl 2):S20-3. PubMed ID: 2690606
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 6.