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

Advanced statistical approaches and new modeling procedures for biopharmaceutical development and manufacturing have received increasing attention. With this forum article, we would like to highlight the need for a consistent terminology and the necessity for appropriate model validation strategies.

Automated summary

There is a growing interest in advanced statistical approaches and new modeling procedures in biopharmaceutical development and manufacturing. This article emphasizes the importance of consistent terminology and appropriate model validation strategies.