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Validation Is Not Verification: Precise Terminology and Scientific Methods in Bioprocess Modeling

Jens Smiatek1, Alexander Jung2, Erich Bluhmki3

  • 1Institute for Computational Physics, University of Stuttgart, D-70569 Stuttgart, Germany; Digitalization Development Biologicals CMC, Boehringer Ingelheim Pharma GmbH & Co. KG, D-88397 Biberach (Riss), Germany.

Trends in Biotechnology
|April 28, 2021
PubMed
Summary

Advanced statistical methods and modeling are crucial for biopharmaceutical development. This article emphasizes consistent terminology and robust model validation for reliable results.

Keywords:
bioprocess modeling and simulationmodel validationscientific practiceterminologyverification

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