BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

713 related articles for article (PubMed ID: 15830253)

  • 1. [Scientific advice by the nationally competent authority and by the EMEA on the conduct of clinical trials].
    Dejas-Eckertz P; Schäffner G
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2005 Apr; 48(4):423-8. PubMed ID: 15830253
    [TBL] [Abstract][Full Text] [Related]  

  • 2. [The Innovation Office of the Paul-Ehrlich-Institut. Regulatory support during the scientific development of ATMP].
    Ziegele B; Dahl L; Müller AT
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2011 Jul; 54(7):857-66. PubMed ID: 21698540
    [TBL] [Abstract][Full Text] [Related]  

  • 3. [Scientific advice by the national and European approval authorities concerning advanced therapy medicinal products].
    Jost N; Schüssler-Lenz M; Ziegele B; Reinhardt J
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2015 Nov; 58(11-12):1207-14. PubMed ID: 26369763
    [TBL] [Abstract][Full Text] [Related]  

  • 4. [Pediatric drug development: ICH harmonized tripartite guideline E11 within the United States of America, the European Union, and Japan].
    Pflieger M; Bertram D
    Arch Pediatr; 2014 Oct; 21(10):1129-38. PubMed ID: 25175054
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Typical pitfalls in applications for marketing authorization of biotechnological products in Europe.
    Schneider CK; Schäffner-Dallmann G
    Nat Rev Drug Discov; 2008 Nov; 7(11):893-9. PubMed ID: 18974748
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency.
    Elsäßer A; Regnstrom J; Vetter T; Koenig F; Hemmings RJ; Greco M; Papaluca-Amati M; Posch M
    Trials; 2014 Oct; 15():383. PubMed ID: 25278265
    [TBL] [Abstract][Full Text] [Related]  

  • 7. [Europe and medicines: role of the EMEA].
    Sauer F
    Ann Pharm Fr; 2000 Jul; 58(4):278-85. PubMed ID: 10915977
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency.
    Regnstrom J; Koenig F; Aronsson B; Reimer T; Svendsen K; Tsigkos S; Flamion B; Eichler HG; Vamvakas S
    Eur J Clin Pharmacol; 2010 Jan; 66(1):39-48. PubMed ID: 19936724
    [TBL] [Abstract][Full Text] [Related]  

  • 9. [Procedure for the marketing authorization of an antibacterial agent].
    López Navas A; García-Escribano Ráez N; Flores Juberías Á; Suárez Gea ML
    Enferm Infecc Microbiol Clin; 2014 Oct; 32(8):529-32. PubMed ID: 25124488
    [TBL] [Abstract][Full Text] [Related]  

  • 10. [Experiences and recommendations of the German Federal Institute for Drugs and Medical Devices (BfArM) concerning clinical investigation of medical devices and the evaluation of serious adverse events (SAE)].
    Renisch B; Lauer W
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2014 Dec; 57(12):1368-75. PubMed ID: 25376539
    [TBL] [Abstract][Full Text] [Related]  

  • 11. [Interplay between marketing authorization and early benefit assessment of drugs].
    Beinlich P; Müller-Berghaus J; Sudhop T; Vieths S; Broich K
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2015 Mar; 58(3):227-31. PubMed ID: 25566840
    [TBL] [Abstract][Full Text] [Related]  

  • 12. The Small- and Medium-sized Enterprises Office (SME Office) at the European Medicines Agency.
    Carr M
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2010 Jan; 53(1):20-3. PubMed ID: 20101799
    [TBL] [Abstract][Full Text] [Related]  

  • 13. [The regulatory framework for complementary and alternative medicines in Europe].
    Knöss W; Stolte F; Reh K
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2008 Jul; 51(7):771-8. PubMed ID: 18584103
    [TBL] [Abstract][Full Text] [Related]  

  • 14. [Authorization procedure of clinical trials with medical devices. First practical analysis of the BfArM].
    Fischer T; Renisch B; Broich K
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2012 Feb; 55(2):270-6. PubMed ID: 22290172
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Granting marketing authorisation for medicines in South East European countries: the point of view of the authority.
    Tomić S; Sucić AF; Martinac AI
    Regul Toxicol Pharmacol; 2010; 57(2-3):325-32. PubMed ID: 20385190
    [TBL] [Abstract][Full Text] [Related]  

  • 16. EMEA and Gene Therapy Medicinal Products Development in the European Union.
    Papaluca Amati M; Pignatti F; Nolte A; Amerasinghe N; Gustafsson D; Moulon I; Le Courtois P
    J Biomed Biotechnol; 2003; 2003(1):3-8. PubMed ID: 12686717
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Fighting trafficking of falsified and substandard medicinal products in Russia.
    Fayzrakhmanov NF
    Int J Risk Saf Med; 2015; 27 Suppl 1():S37-40. PubMed ID: 26639702
    [TBL] [Abstract][Full Text] [Related]  

  • 18. [Approval of clinical trials of immunobiological medicinal products at the Paul Ehrlich Institute].
    Krafft H; Cichutek K
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2005 Feb; 48(2):168-72. PubMed ID: 15726457
    [TBL] [Abstract][Full Text] [Related]  

  • 19. The regulatory system in europe with special emphasis on allergen products.
    Lorenz AR; Luttkopf D; Seitz R; Vieths S
    Int Arch Allergy Immunol; 2008; 147(4):263-75. PubMed ID: 18648190
    [TBL] [Abstract][Full Text] [Related]  

  • 20. [National and European drug approval procedures].
    Mohrbutter KP
    Z Arztl Fortbild Qualitatssich; 1997 Nov; 91(7):593-6. PubMed ID: 9527447
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 36.