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 *

348 related articles for article (PubMed ID: 18218324)

  • 1. WHO informal consultation on regulatory evaluation of therapeutic biological medicinal products held at WHO Headquarters, Geneva, 19-20 April 2007.
    Joung J; Robertson JS; Griffiths E; Knezevic I;
    Biologicals; 2008 Jul; 36(4):269-76. PubMed ID: 18218324
    [TBL] [Abstract][Full Text] [Related]  

  • 2. 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]  

  • 3. WHO standards for biotherapeutics, including biosimilars: an example of the evaluation of complex biological products.
    Knezevic I; Griffiths E
    Ann N Y Acad Sci; 2017 Nov; 1407(1):5-16. PubMed ID: 28905423
    [TBL] [Abstract][Full Text] [Related]  

  • 4. [The Polish Task Force position statement on safety of biologic treatment with monoclonal antibodies and soluble receptors].
    Jahnz-Rozyk K; Wiesik-Szewczyk E;
    Pol Merkur Lekarski; 2014 Jul; 37(217):5-9. PubMed ID: 25154192
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Biosimilars: controversies as illustrated by rhGH.
    Declerck PJ; Darendeliler F; Góth M; Kolouskova S; Micle I; Noordam C; Peterkova V; Volevodz NN; Zapletalová J; Ranke MB
    Curr Med Res Opin; 2010 May; 26(5):1219-29. PubMed ID: 20302553
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Interchangeability among reference insulin analogues and their biosimilars: regulatory framework, study design and clinical implications.
    Dowlat HA; Kuhlmann MK; Khatami H; Ampudia-Blasco FJ
    Diabetes Obes Metab; 2016 Aug; 18(8):737-46. PubMed ID: 27097592
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Biosimilars: Rationale and current regulatory landscape.
    Olech E
    Semin Arthritis Rheum; 2016 Apr; 45(5 Suppl):S1-10. PubMed ID: 26947438
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Review on the worldwide regulatory framework for biosimilars focusing on the Mexican case as an emerging market in Latin America.
    Ibarra-Cabrera R; Mena-Pérez SC; Bondani-Guasti A; García-Arrazola R
    Biotechnol Adv; 2013 Dec; 31(8):1333-43. PubMed ID: 23714280
    [TBL] [Abstract][Full Text] [Related]  

  • 9. [Biosimilars in oncology: a therapeutic alternative to the reference products?].
    Ludwig WD; Dicheva S
    Z Gastroenterol; 2016 Nov; 54(11):1223-1229. PubMed ID: 27723912
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Biosimilar Drugs for Multiple Sclerosis: An Unmet International Need or a Regulatory Risk?
    Rivera VM
    Neurol Ther; 2019 Dec; 8(2):177-184. PubMed ID: 31313222
    [TBL] [Abstract][Full Text] [Related]  

  • 11. 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]  

  • 12. 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]  

  • 13. PDA Biosimilars Workshop Report (September 27-28, 2018)-Getting It Right the First Time for Biosimilar Marketing Applications.
    Krause S; Lacana E; Welch J; Shapiro M; Downey C; Chung J; Zhou Q; Van Der Plas M; Depatie C; Ingram B; Srebalus-Barnes C; Polozova A; Rellahan B; Choi D; Burdick R; Stangler T; Shacter E
    PDA J Pharm Sci Technol; 2019; 73(4):401-416. PubMed ID: 31004040
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Regulatory evaluation of biosimilars throughout their product life-cycle.
    Kang HN; Knezevic I
    Bull World Health Organ; 2018 Apr; 96(4):281-285. PubMed ID: 29695884
    [TBL] [Abstract][Full Text] [Related]  

  • 15. 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]  

  • 16. The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019.
    Kang HN; Thorpe R; Knezevic I;
    Biologicals; 2020 May; 65():1-9. PubMed ID: 32224101
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Biologicals and biosimilars: safety issues in Europe.
    Portela MDCC; Sinogas C; Albuquerque de Almeida F; Baptista-Leite R; Castro-Caldas A
    Expert Opin Biol Ther; 2017 Jul; 17(7):871-877. PubMed ID: 28540760
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Is the advent of biosimilars affecting the practice of nephrology and the safety of patients?
    Ronco C
    Contrib Nephrol; 2008; 161():261-270. PubMed ID: 18451686
    [TBL] [Abstract][Full Text] [Related]  

  • 19. WHO technical workshop on stability of reference materials for biological medicines and in vitro diagnostics, Geneva, Switzerland, 28-29 November 2005.
    Tahlan A; Barrowcliffe T; Das RG; Shin J; Wood D
    Biologicals; 2007 Oct; 35(4):361-5. PubMed ID: 17517522
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Demonstration of biosimilarity, extrapolation of indications and other challenges related to biosimilars in Europe.
    Tsiftsoglou AS; Trouvin JH; Calvo G; Ruiz S
    BioDrugs; 2014 Dec; 28(6):479-86. PubMed ID: 25391420
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 18.