BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

193 related articles for article (PubMed ID: 20920853)

  • 1. An Overview of Current Regulatory Requirements for Approval of Biosimilar Insulins.
    Heinemann L; Khatami H; McKinnon R; Home P
    Diabetes Technol Ther; 2015 Jul; 17(7):510-26. PubMed ID: 25789689
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Regulating medicines in Europe: the European Medicines Agency, marketing authorisation, transparency and pharmacovigilance.
    Permanand G; Mossialos E; McKee M
    Clin Med (Lond); 2006; 6(1):87-90. PubMed ID: 16521363
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Biosimilars in Developed and Developing East and Southeast Asian Countries: Japan, South Korea, and Malaysia-Overview, Evolution, and Regulations Assessment.
    Bas TG; Oliu Castillo C
    Biomed Res Int; 2016; 2016():5910403. PubMed ID: 27213153
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Ten years of biosimilar recombinant human growth hormone in Europe.
    Saenger P
    Drug Des Devel Ther; 2017; 11():1505-1507. PubMed ID: 28553081
    [TBL] [Abstract][Full Text] [Related]  

  • 5. The emergence of biosimilar insulin preparations--a cause for concern?
    Owens DR; Landgraf W; Schmidt A; Bretzel RG; Kuhlmann MK
    Diabetes Technol Ther; 2012 Nov; 14(11):989-96. PubMed ID: 23046400
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Bridging the gap: The future of biosimilars regulations.
    Jarab AS; Abu Heshmeh SR; Al Meslamani AZ
    Hum Vaccin Immunother; 2024 Dec; 20(1):2362450. PubMed ID: 38887055
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Factors associated with hematological adverse reactions of drugs authorized via the centralized procedure.
    Stević I; Janković SM; Georgiev AM; Marinković V; Lakić D
    Sci Rep; 2024 Apr; 14(1):9074. PubMed ID: 38643204
    [TBL] [Abstract][Full Text] [Related]  

  • 8. The Evolution of Drug Regulatory Sciences in the Netherlands: More than a Country Report.
    Pasmooij AMG; Mol PGM; Bot JC; Leufkens HGM
    Clin Pharmacol Ther; 2024 Jul; 116(1):64-71. PubMed ID: 38679943
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Status of new medicines approved by the European Medicines Evaluation Agency regarding paediatric use.
    Impicciatore P; Choonara I
    Br J Clin Pharmacol; 1999 Jul; 48(1):15-8. PubMed ID: 10383554
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Future of the European Union regulatory network in the context of the uptake of new medicines.
    Hoebert JM; Irs A; Mantel-Teeuwisse AK; Leufkens HG
    Br J Clin Pharmacol; 2013 Jul; 76(1):1-6. PubMed ID: 23043328
    [No Abstract]   [Full Text] [Related]  

  • 11. Frequency of Approval and Marketing of Biosimilars With a Skinny Label and Associated Medicare Savings.
    Egilman AC; Van de Wiele VL; Rome BN; Darrow JJ; Tu SS; Kesselheim AS; Sarpatwari A
    JAMA Intern Med; 2023 Jan; 183(1):82-84. PubMed ID: 36441536
    [TBL] [Abstract][Full Text] [Related]  

  • 12. The first European Union approval of a new medicine to treat cardiovascular diseases in 2023: why is it important to collaborate with the European Medicines Agency?
    Szymański P; Bossano Prescott EI; Weidinger F
    Eur Heart J; 2024 Jan; 45(1):7-9. PubMed ID: 37850604
    [No Abstract]   [Full Text] [Related]  

  • 13. Where is European Regulation 536/2014 Taking Us?
    Fox AW
    Pharmaceut Med; 2023 Sep; 37(5):343-347. PubMed ID: 37353716
    [TBL] [Abstract][Full Text] [Related]  

  • 14. An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology.
    Sani NM; McAuslane N; Kasbon SH; Ahmad R; Yusof FAM; Patel P
    Ther Innov Regul Sci; 2020 Sep; 54(5):1215-1224. PubMed ID: 32865804
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Post-approval quality-related regulatory actions for biopharmaceuticals approved in the European Union and the United States between 1995 and 2019.
    Alsamil AM; Gardarsdottir H; Leufkens HG; Egberts TC; Giezen TJ
    Drug Discov Today; 2023 Oct; 28(10):103725. PubMed ID: 37487844
    [TBL] [Abstract][Full Text] [Related]  

  • 16. A new approach to psychiatric drug approval in Europe.
    Barbui C; Bighelli I
    PLoS Med; 2013 Oct; 10(10):e1001530. PubMed ID: 24143137
    [TBL] [Abstract][Full Text] [Related]  

  • 17. [Biosimilars: regulatory status for approval].
    Herrero Ambrosio A
    Farm Hosp; 2010 Mar; 34 Suppl 1():16-8. PubMed ID: 20920853
    [TBL] [Abstract][Full Text] [Related]  

  • 18. [Biosimilars].
    Krämer I
    Ther Umsch; 2011 Nov; 68(11):659-66. PubMed ID: 22045529
    [TBL] [Abstract][Full Text] [Related]  

  • 19. [Biosimilar medicines. Scientific and legal disputes].
    Dorantes Calderón B; Montes Escalante IM
    Farm Hosp; 2010 Mar; 34 Suppl 1():29-44. PubMed ID: 20920856
    [TBL] [Abstract][Full Text] [Related]  

  • 20.
    ; ; . PubMed ID:
    [No Abstract]   [Full Text] [Related]  

    [Next]    [New Search]
    of 10.