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processanalytisk teknologi (PAT)

process analytical technology [ENGLISH]

A system for designing, analyzing and controlling manufacturing processes and performance through the evaluation of critical quality attributes and critical process parameters of raw and in-process materials and processes, to ensure final product quality.

processanalytisk teknologi [SWEDISH]

System för att designa, analysera och kontrollera tillverkningsprocesser och prestanda genom utvärdering av kritiska kvalitetsattribut och kritiska processparametrar för råmaterial och processer, för att säkerställa slutproduktens kvalitet.


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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