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Establishment of an Equivalence Acceptance Criterion for Accelerated Stability Studies
In this article, the use of statistical equivalence testing for providing evidence of process comparability in an accelerated stability study is advocated over the use of a test of differences. TheExpand
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Using risk analysis in process validation
Process validation is used to confirm that the resulting product from a specified process consistently conforms to product requirements. A risk-based approach to process validation provides aExpand
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Process Design: Stage 1 of the FDA Process Validation Guidance
This is the first of three chapters that describe statistical approaches related to the three stages of process validation described in the FDA Process Validation Guidance for Industry (2011). Expand
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A graphical representation for a statistical test of average equivalence and variance comparison with process data
This paper provides a graphical approach for presenting results of a statistical test of average equivalence with process data and a graphical representation of process change in variance. Expand
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Using Logistic Regression to Evaluate New Lid Designs
Abstract New product designs from competing vendors must often be evaluated in order to make the best decision on which design to use in manufacturing. In most cases, the designs must be challengedExpand
Statistical Methods for Analytical Comparability
This paper presents an overview and use of equivalence tests and statistical intervals as options to demonstrate analytical comparability. Expand
Statistical Methods for CMC Applications
In this chapter, we provide statistical methods that are useful in CMC applications. Our goal is to provide a description of these methods without delving deeply into the theoretical aspects.Expand
Process Qualification: Stage 2 of the FDA Process Validation Guidance
In Chap. 3, the first stage of the FDA’s 2011 process validation guidance was described demonstrating various options to drive process understanding using experimental design . The resulting processExpand
Analytical Comparability and Similarity
In all manufacturing settings, there is an inherent drive to improve product through the reduction in process variation, implementing new technology, increasing efficiency, optimizing resources, and improving customer experience through innovation. Expand