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effektstudie efter det att produkten godkänts (PAES)

post-authorization efficacy study [ENGLISH]

Study performed after marketing authorization that aims to further evaluate the efficacy of a medicinal product, perhaps where uncertainty related to the product’s efficacy is identified.

effektstudie efter det att produkten godkänts [SWEDISH]

Studie som utförs efter godkännande för försäljning och som syftar till att ytterligare utvärdera effekten av ett läkemedel, kanske när osäkerhet i samband med produktens effekt identifieras.


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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