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kvalificering av biomarkör

biomarker qualification [ENGLISH]

Certification of the acceptability of a biomarker for a specific use in pharmaceutical research and development. The Agency gives opinions on biomarker qualifications. 

kvalificering av biomarkör [SWEDISH]

Kvalificering av acceptansen av en biomarkör för en specifik användning inom farmaceutisk forskning och utveckling. Myndigheten ger yttranden om kvalifikationer av biomarkörer.


Resources and references

Definitions have been translated into the Swedish language from the following sources:

  1. 1. American Society of Gene and Cell Therapy Glossary
  2. 2. Clinical Trials Information System
  3. 3. EMA Glossary of Regulatory Terms
  4. 4. EMA Medical Terms simplifier
  5. 5. Glossary of Terms used in EU Clinical Trials Register
  6. 6. Glossary of Terms U.S Food and Drug Administration
  7. 7. National Human Genome Research Institute “Talking Glossary of Genomic and Genetic Terms”
  8. 8. The Glossary for Advanced Therapies Regen. Med. Dec 2020 Vol. 15 No. 12 Suppl. 1
  9. 9. Toolkit For Patient Focused Therapy Development Glossary

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