Comparison of drug dissolution profiles: a proposal based on tolerance limits

DOI10.1002/SIM.7072MaRDI QIDQ6918931zbMATH OpenFDO

Authors Shuyan Zhai, Thomas Mathew, Yi Huang

Publication date 9 October 2025

Published in Statistics in Medicine (Search for Journal in Brave)

Full work available at URL https://doi.org/10.1002/SIM.7072

zbMATH Keywords

parametric bootstrapbootstrap calibrationorder statisticssimilarity factordissolution testingdifference factor

Mathematics Subject Classification ID

Applications of statistics to biology and medical sciences; meta analysis (62P10)

Cites work

• scientific article; zbMATH DE number 708500 (Why is no real title available?)
• scientific article; zbMATH DE number 1419972 (Why is no real title available?)
• A new chi-square approximation to the distribution of non-negative definite quadratic forms in non-central normal variables
• Multipoint dissolution specification and acceptance sampling rule based on profile modeling and principal component analysis
• Statistical Tolerance Regions: Theory, Applications, and Computation

Cited in

(1)

• Regulatory assessment of drug dissolution profiles comparability via maximum deviation

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