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

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• Assessing Distributions of Estimated Drug Shelf Lives in Stability Analysis
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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)

Cites Work

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

Cited In (10)

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

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