Statistical Design and Analysis of Stability Studies

DOI10.1201/9781584889069MaRDI QIDQ5423786zbMATH OpenOpenAlexFDO

Authors Shein-Chung Chow

Publication date 31 October 2007

Full work available at URL https://doi.org/10.1201/9781584889069

Mathematics Subject Classification ID

Introductory exposition (textbooks, tutorial papers, etc.) pertaining to statistics (62-01) Applications of statistics to biology and medical sciences; meta analysis (62P10) Medical applications (general) (92C50) Physiological, cellular and medical topics (92C99)

Recommendations

• Overview Of Stability Study Designs
• Assessing Distributions of Estimated Drug Shelf Lives in Stability Analysis
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• Bioequivalence Studies in Drug Development
• Statistical Inference in Stability Analysis

Cited in

(6)

• scientific article; zbMATH DE number 5864706 (Why is no real title available?)
• Overview Of Stability Study Designs
• A non-inferiority test for diagnostic accuracy in the absence of the golden standard test based on the paired partial areas under receiver operating characteristic curves
• scientific article; zbMATH DE number 6448273 (Why is no real title available?)
• Tolerance Intervals Under a Class of Unbalanced Linear Mixed Models
• Using accelerated drug stability results to inform long-term studies in shelf life determination

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