A Unified Framework for Detecting Out-of-Trend Results in Stability Studies
Author:
Affiliation:
1. MedImmune LLC, Gaithersburg, MD
Publisher
Informa UK Limited
Subject
Pharmaceutical Science,Statistics and Probability
Link
https://www.tandfonline.com/doi/pdf/10.1080/19466315.2017.1371070
Reference22 articles.
1. The Effect of Variance Function Estimation on Nonlinear Calibration Inference in Immunoassay Data
2. Bayesian hierarchical modeling of drug stability data
3. Estimation of the shelf-life of drugs with mixed effects models
4. Regression and calibration with nonconstant error variance
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2. Out-of-Trend Statistics in The Pharmaceutical Industry: A Gain Leap in Assuring the Quality of The product;Asian Journal of Research in Chemistry;2023-11-28
3. Evaluating the potential for optimization of axial back-mixing in continuous pharmaceutical manufacturing;Computers & Chemical Engineering;2021-04
4. Regression control chart with unknown parameters for detection of out-of-trend results in pharmaceutical on-going stability studies;Journal of Pharmaceutical and Biomedical Analysis;2020-09
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