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klinisk prövning

clinical trial [ENGLISH]

1. Clinical research method for testing interventions in one or more human participants to assess safety and efficacy. 2. A study performed to investigate the safety or efficacy of a medicine. For human medicines, these studies are carried out in human volunteers.

klinisk prövning [SWEDISH]

Undersökning avseende människor vilken genomförs med avsikten att upptäcka eller verifiera de kliniska, farmakologiska eller andra farmakodynamiska effekterna av ett eller flera läkemedel, identifiera eventuella biverkningar av ett eller flera läkemedel, eller studera absorption, distribution, metabolism och utsöndring av ett eller flera läkemedel, med syftet att säkerställa att dessa läkemedel är säkra och/eller effektiva.

2024-01-29

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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 https://www.asgct.org/education/more-resources/glossary
  2. 2. Clinical Trials Information System https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/clinical-trials-human-medicines/clinical-trials-information-system
  3. 3. EMA Glossary of Regulatory Terms https://www.ema.europa.eu/en/about-us/glossaries/glossary-regulatory-terms
  4. 4. EMA Medical Terms simplifier https://www.ema.europa.eu/en/documents/other/ema-medical-terms-simplifier_en.pdf
  5. 5. Glossary of Terms used in EU Clinical Trials Register https://www.clinicaltrialsregister.eu/doc/EU_Clinical_Trials_Register_Glossary.pdf
  6. 6. Glossary of Terms U.S Food and Drug Administration https://www.fda.gov/patients/clinical-trials-what-patients-need-know/glossary-terms
  7. 7. National Human Genome Research Institute “Talking Glossary of Genomic and Genetic Terms” https://www.genome.gov/genetics-glossary/m#glossary
  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 https://toolkit.ncats.nih.gov/glossary-2/

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