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

DOI10.1080/03610918.2013.854906MaRDI QIDQ5265832zbMATH OpenOpenAlexFDO

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

drug stability studyestimationlinear regressionlot-to-lot variabilitymeasurement errorminimal acceptable levelnormal distributionshelf-life

Mathematics Subject Classification ID

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

Recommendations

• Assessing Distributions of Estimated Drug Shelf Lives in Stability Analysis
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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

(11)

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

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