Statistical Inference in Stability Analysis

DOI10.2307/2532789MaRDI QIDQ4842869zbMATH OpenOpenAlexFDO

Authors Jun Shao, Shein-Chung Chow

Publication date 3 October 1995

Published in Biometrics (Search for Journal in Brave)

Full work available at URL https://doi.org/10.2307/2532789

zbMATH Keywords

batch-to-batch variationcovariatesdrug shelf-lifeexpiration dating periodlabeled shelf- lifelower confidence boundstability analysis

Mathematics Subject Classification ID

Applications of statistics to biology and medical sciences; meta analysis (62P10) Kinetics in biochemical problems (pharmacokinetics, enzyme kinetics, etc.) (92C45)

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Cited in

(19)

• Drug shelf-life estimation
• Estimating a single shelf-life for multiple batches
• Shelf-life and its estimation in drug stability studies
• scientific article; zbMATH DE number 5864706 (Why is no real title available?)
• Empirical Likelihood Based Rank Regression Inference
• Multiple Comparison Procedures for Pooling Batches in Stability Studies
• On stability designs in drug shelf-life estimation
• A Two-Way Analysis of Covariance Model for Classification of Stability Data
• Overview Of Stability Study Designs
• Monitoring the Stability of Human Vaccines
• A Quantitative Assessment of Factors Influencing the Probability of Postmarketing Out-of-Specification Observations
• Stability Analysis with Discrete Responses
• Rank Regression in Stability Analysis
• Assessing Distributions of Estimated Drug Shelf Lives in Stability Analysis
• On the estimation of variance components in stability analysis
• Estimating drug shelf-life with unknown lot-to-lot variability
• Statistical Design and Analysis of Stability Studies
• 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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