Estimating drug shelf-life with unknown lot-to-lot variability

DOI10.1080/03610918.2013.854906zbMATH Open1328.62440OpenAlexW2083731221MaRDI QIDQ5265832FDOQ5265832

Authors N. Srimaneekarn, Seksan Kiatsupaibul, Wei Liu, Anthony J. Hayter

Publication date 29 July 2015

Published in Communications in Statistics. Simulation and Computation (Search for Journal in Brave)

Full work available at URL https://doi.org/10.1080/03610918.2013.854906

zbMATH Keywords

measurement errorestimationlinear regressionnormal distributionshelf-lifedrug stability studylot-to-lot variabilityminimal acceptable level

Mathematics Subject Classification ID

Linear regression; mixed models (62J05) Parametric tolerance and confidence regions (62F25)

Recommendations

• Assessing Distributions of Estimated Drug Shelf Lives in Stability Analysis
• Drug shelf-life estimation
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Cites work

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

Cited in

(10)

• A Statistical Model for Shelf Life Estimation Using Sensory Evaluations Scores
• Shelf-life and its estimation in drug stability studies
• Estimating a single shelf-life for multiple batches
• COMPARISON OF BRACKETING AND MATRIXING DESIGNS FOR A TWO-YEAR STABILITY STUDY
• A Quantitative Assessment of Factors Influencing the Probability of Postmarketing Out-of-Specification Observations
• On the estimation of variance components in stability analysis
• Stability Analysis with Discrete Responses
• Drug shelf-life estimation
• Assessing Distributions of Estimated Drug Shelf Lives in Stability Analysis
• Statistical Inference in Stability Analysis

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