GCP-enheden ved Århus Universitetshospital

Ugeskrift for Laeger

Volumn 162, Issue 32, 2000, Pages 4288-4290

  Jørgensen, Annette ^a   Fabricius, Søren ^b   Nexø, Ebba ^b   Djurhuus, Jens Christian ^b   Rosenberg, Raben ^b   Hammer, Ulf ^b   Christiansen, Jens Sandahl ^b  

^a AARHUS UNIVERSITY   (Denmark)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL PHARMACOLOGY; CLINICAL TRIAL; DENMARK; DRUG APPROVAL; HEALTH CARE QUALITY; HOSPITAL SUBDIVISIONS AND COMPONENTS; HUMAN; STANDARD; UNIVERSITY HOSPITAL;

CLINICAL TRIALS; DENMARK; DRUG APPROVAL; HOSPITAL UNITS; HOSPITALS, UNIVERSITY; HUMANS; PHARMACOLOGY, CLINICAL; QUALITY ASSURANCE, HEALTH CARE;

EID: 0034617523     PISSN: 00415782     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (6)

1. The European Agency for the Evaluation of Medicinal Products. Note for guidance on good clinical practice (CPMP/ICH/135/95). London: The European Agency for the Evaluation of Medicinal Products, 1997.
2. Hvidberg EF. Klinisk lægemiddelafprøvning. Regulering, harmonisering og betydning af »Good Clinical Practice«. Ugeskr Læger 1994; 156: 789-93.
3. The Commission of the European Communities: Commission directive 91/507/EEC of 19 July 1991 modifying the annex to council directive 75/318/EEC on the approximation of the laws of member states relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products. Brussels: The Commission of the European Communities, 1991.
4. Astrup KG. Forslag til direktiv om kliniske afprovninger. Farmaceuten 1998; 6: 160-3.
5. Babbedge R. Advent of the EU Directive on Clinical Trials - hopes for 2000. Good Clin Pract J 1998; 6: 27-30.
6. Holbøll C, Beck-Nielsen H. Statens Sundhedsvidenskabelige Forskningsråd. Kontrol med klinisk forskning. Ugeskr Læger 1999; 161: 6795.