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kvalitet genom design (QbD)

quality by design [ENGLISH]

Systematic approach used to ensure the design, development and manufacture of high-quality medicinal products through a strong understanding of the product, the process by which it is developed and the risks involved.

kvalitet genom design [SWEDISH]

Systematiskt tillvägagångssätt som används för att säkerställa design, utveckling och tillverkning av högkvalitativa läkemedel genom en stark förståelse för produkten, processen genom vilken den utvecklas och de risker som är involverade.


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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