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 *

191 related articles for article (PubMed ID: 21838658)

  • 1. Regulatory considerations for generic or biosimilar low molecular weight heparins.
    García-Arieta A; Blázquez A
    Curr Drug Discov Technol; 2012 Jun; 9(2):137-42. PubMed ID: 21838658
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Biosimilars: policy, clinical, and regulatory considerations.
    Gottlieb S
    Am J Health Syst Pharm; 2008 Jul; 65(14 Suppl 6):S2-8. PubMed ID: 18591712
    [TBL] [Abstract][Full Text] [Related]  

  • 3. 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]  

  • 4. Low molecular weight heparins copies: are they considered to be generics or biosimilars?
    Minghetti P; Cilurzo F; Franzé S; Musazzi UM; Itri M
    Drug Discov Today; 2013 Mar; 18(5-6):305-11. PubMed ID: 23153556
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Biosimilar drugs : concerns and opportunities.
    Genazzani AA; Biggio G; Caputi AP; Del Tacca M; Drago F; Fantozzi R; Canonico PL
    BioDrugs; 2007; 21(6):351-6. PubMed ID: 18020619
    [TBL] [Abstract][Full Text] [Related]  

  • 6. 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]  

  • 7. Statistical and regulatory considerations in assessments of interchangeability of biological drug products.
    Tóthfalusi L; Endrényi L; Chow SC
    Eur J Health Econ; 2014 May; 15 Suppl 1(Suppl 1):S5-11. PubMed ID: 24832831
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Modified Regulatory Pathways to Approve Generic Drugs in the US and a Systematic Review of Their Outcomes.
    Kesselheim AS; Polinski JM; Fulchino LA; Isaman DL; Gagne JJ
    Drugs; 2015 Apr; 75(6):633-50. PubMed ID: 25822610
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Equivalence and regulatory approaches of nonbiological complex drug products across the United States, the European Union, and Turkey.
    Oner ZG; Michel SLJ; Polli JE
    Ann N Y Acad Sci; 2017 Nov; 1407(1):26-38. PubMed ID: 29090833
    [TBL] [Abstract][Full Text] [Related]  

  • 10. On safety margin for drug interchangeability.
    Zheng J; Chow SC; Song F
    J Biopharm Stat; 2017; 27(2):293-307. PubMed ID: 27911675
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Structural and functional characterization of low-molecular-weight heparins: impact on the development of guidelines for generic products.
    Adiguzel C; Jeske WP; Hoppensteadt D; Walenga JM; Bansal V; Fareed J
    Clin Appl Thromb Hemost; 2009; 15(2):137-44. PubMed ID: 19357102
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Low molecular weight heparins differ substantially: impact on developing biosimilar drugs.
    Walenga JM; Jackson CM; Kessler CM
    Semin Thromb Hemost; 2011 Apr; 37(3):322-7. PubMed ID: 21455866
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Biosimilars: A consideration of the regulations in the United States and European union.
    Daller J
    Regul Toxicol Pharmacol; 2016 Apr; 76():199-208. PubMed ID: 26732800
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Implementing the additional strength biowaiver for generics: EMA recommended approaches and challenges for a US-FDA submission.
    Cardot JM; Garcia-Arieta A; Paixao P; Tasevska I; Davit B
    Eur J Pharm Sci; 2018 Jan; 111():399-408. PubMed ID: 29032306
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Development and regulation of biosimilars: current status and future challenges.
    Tsiftsoglou AS; Ruiz S; Schneider CK
    BioDrugs; 2013 Jun; 27(3):203-11. PubMed ID: 23553340
    [TBL] [Abstract][Full Text] [Related]  

  • 16. 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]  

  • 17. [Regulation about generics approval].
    Laguna-Goya N; Blázquez-Pérez A; Pozo-Hernández C
    Farm Hosp; 2006; 30(6):379-84. PubMed ID: 17298196
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Similarities and differences in the oncology drug approval process between FDA and European Union with emphasis on in vitro companion diagnostics.
    Senderowicz AM; Pfaff O
    Clin Cancer Res; 2014 Mar; 20(6):1445-52. PubMed ID: 24634467
    [TBL] [Abstract][Full Text] [Related]  

  • 19. 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]  

  • 20. The therapeutic equivalence of complex drugs.
    Schellekens H; Klinger E; Mühlebach S; Brin JF; Storm G; Crommelin DJ
    Regul Toxicol Pharmacol; 2011 Feb; 59(1):176-83. PubMed ID: 20951177
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 10.