BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

336 related articles for article (PubMed ID: 15830252)

  • 1. [Clinical trials in Germany and in the EU in the new legislative environment. An analysis from the industry's point of view].
    Heidenreich K; Möritz A; Löffler H; Oberle-Rolle B
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2005 Apr; 48(4):415-22. PubMed ID: 15830252
    [TBL] [Abstract][Full Text] [Related]  

  • 2. [The 12th amendment to the German Drug Law. Chances and obstacles for investigator-initiated clinical trials].
    Dreier G; Marx C; Schmoor C; Maier-Lenz H
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2005 Apr; 48(4):445-52. PubMed ID: 15830256
    [TBL] [Abstract][Full Text] [Related]  

  • 3. [Harmonisation of regulatory requirements for clinical trials on medicinal products for human use in the Directive 2001/20/EC and complementary guidance. Implementation of the 12th Law Amending the German Drug Law].
    Geisler I; Hofmann HP; Nickel L
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2005 Feb; 48(2):141-6. PubMed ID: 15726454
    [TBL] [Abstract][Full Text] [Related]  

  • 4. [Recording and reporting adverse reactions in clinical trials. New legal provisions according to the 12th Law Amending the German Drug Law (AMG) and the Ordinance on GCP (GCP-V)].
    Eckhardt K; Cremer-Schaeffer P; König J; Paeschke N
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2005 Feb; 48(2):173-80. PubMed ID: 15726458
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to? A review of the new EU legislation on pharmacovigilance.
    Borg JJ; Aislaitner G; Pirozynski M; Mifsud S
    Drug Saf; 2011 Mar; 34(3):187-97. PubMed ID: 21332243
    [TBL] [Abstract][Full Text] [Related]  

  • 6. [The authorization of clinical trials by the federal authorities].
    Schriever J; Schwarz G; Steffen C; Krafft H
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2009 Apr; 52(4):377-86. PubMed ID: 19266174
    [TBL] [Abstract][Full Text] [Related]  

  • 7. [Decree on the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use].
    Schwerdtfeger WK
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2005 Feb; 48(2):147-54. PubMed ID: 15726455
    [TBL] [Abstract][Full Text] [Related]  

  • 8. [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]  

  • 9. [GCP inspections of clinical trials].
    Schwarz G
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2005 Feb; 48(2):181-8. PubMed ID: 15726459
    [TBL] [Abstract][Full Text] [Related]  

  • 10. [The community clinical trial system EudraCT at the EMEA for the monitoring of clinical trials in Europe].
    Krafft H
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2005 Apr; 48(4):453-8. PubMed ID: 15830257
    [TBL] [Abstract][Full Text] [Related]  

  • 11. [The GCP directive--consequences for clinical drug research].
    Gluud CN
    Ugeskr Laeger; 2003 Apr; 165(16):1662-4. PubMed ID: 12756824
    [TBL] [Abstract][Full Text] [Related]  

  • 12. [Principles of the EU Clinical Trials Regulation No 536/2014 : What will change?].
    Mende A; Frech M; Riedel C
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2017 Aug; 60(8):795-803. PubMed ID: 28685215
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Experiences with GLP/GCP from the pharmaceutical industry's viewpoint.
    Legler UF
    Methods Find Exp Clin Pharmacol; 1993 May; 15(4):233-6. PubMed ID: 8361261
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Germany opposes EU plans for regulating clinical trials owing to lack of ethical standards.
    Tuffs A
    BMJ; 2012 Oct; 345():e6640. PubMed ID: 23033377
    [No Abstract]   [Full Text] [Related]  

  • 15. [Clinical trials for medicinal products. New European and national legal rules].
    Kreutz G
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2005 May; 48(5):524-9. PubMed ID: 15887061
    [TBL] [Abstract][Full Text] [Related]  

  • 16. [The effects of the 12th and 14th amendments to the AMG (Medical Preparations Act) on paediatric pharmaceutical research--a survey of the new regulations].
    Kölch M; Lippert HD; Fegert JM
    Z Kinder Jugendpsychiatr Psychother; 2006 Mar; 34(2):117-26. PubMed ID: 16610597
    [TBL] [Abstract][Full Text] [Related]  

  • 17. [Implementation status of Regulation EU 536/2014 in the member states].
    Stahl E
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2017 Aug; 60(8):836-840. PubMed ID: 28638933
    [TBL] [Abstract][Full Text] [Related]  

  • 18. [Quality requirements governing non-commercial clinical trials within the framework of clinical drug development in humans in the EU. Challenges, opportunities, and questions experienced by treatment centres].
    Boos J
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2005 Feb; 48(2):196-203. PubMed ID: 15726461
    [TBL] [Abstract][Full Text] [Related]  

  • 19. [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]  

  • 20. [Quality requirements for investigational medicinal products. The state authorities' point of view].
    Neuhaus J
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2005 Feb; 48(2):189-95. PubMed ID: 15726460
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 17.