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fas IV-studie

phase IV clinical trial [ENGLISH]

Post-authorization clinical trial performed in many patients to determine any rare or long-term adverse effects of a new treatment.

fas IV-studie [SWEDISH]

Klinisk prövning som görs auktorisation utförd på många patienter för att fastställa eventuella sällsynta eller långsiktiga biverkningar av en ny behandling.


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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