Robustness and Efficiency Considerations When Testing Process Reliability with a Limit of Detection

Processes in biotechnology are considered reliable if they produce samples satisfying regulatory benchmarks. For example, laboratories may be required to show that levels of an undesirable analyte rarely (e.g., in less than 5% of samples) exceed a tolerance threshold. This can be challenging when me...

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Bibliographic Details
Main Authors: Laura S. Bumbulis, Richard J. Cook
Format: Article
Language:English
Published: MDPI AG 2025-04-01
Series:Mathematics
Subjects:
Online Access:https://www.mdpi.com/2227-7390/13/8/1274
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