Use of Bayesian Methods to Analyze and Visualize Content Uniformity Capability Versus United States Pharmacopeia and ASTM Standards

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• 作者：Jeffrey D. Hofer ; ^{hofer_jeffrey_d@lilly.com} ; Adam P. Rauk
• 关键词：content uniformity ; mathematical model ; simulations ; US Pharmacopeia ; formulation
• 刊名：Journal of Pharmaceutical Sciences
• 出版年：2017
• 出版时间：February 2017
• 年：2017
• 卷：106
• 期：2
• 页码：554-559
• 全文大小：907 K
• 卷排序：106

文摘

The purpose of this work was to develop a straightforward and robust approach to analyze and summarize the ability of content uniformity data to meet different criteria. A robust Bayesian statistical analysis methodology is presented which provides a concise and easily interpretable visual summary of the content uniformity analysis results. The visualization displays individual batch analysis results and shows whether there is high confidence that different content uniformity criteria could be met a high percentage of the time in the future. The 3 tests assessed are as follows: (a) United States Pharmacopeia Uniformity of Dosage Units <905>, (b) a specific ASTM E2810 Sampling Plan 1 criterion to potentially be used for routine release testing, and (c) another specific ASTM E2810 Sampling Plan 2 criterion to potentially be used for process validation. The approach shown here could readily be used to create similar result summaries for other potential criteria.