![]() ![]() The type of descriptive statistics to be applicable depends on how the data is collected. 1 Descriptive Statistical MethodsÄescriptive statistics are often the most important part of the statistical contribution to SSMQ. The results of the surveys are not presented in these articles but are available in an expanded BioPhorum white paper on the topic. This part discusses statistical methods for comparing SSM outputs to at-scale outputs and covers descriptive statistical methods, inferential methods, difference tests, equivalence tests, quality range methods, and multivariate analysis. ![]() Statistical tools for data analysis in manufacturing how to#Part 2 covered the current opinion on how to execute small-scale model qualification for both upstream and downstream SSMs and analytical setup. Part 1 discussed the applications, including viral clearance, quality oversight, and design considerations, for justification of SSMs. In order to write the articles, surveys were conducted among BioPhorum workstream team members on the practices of conducting small-scale model justification. Their purpose is to provide reference documents for bioprocess professionals who will carry out small-scale model justification. This article is the final in a three-part series that summarizes the discussions and exchanges of a BioPhorum Development Group workstream on small-scale model justification. Luo (GlaxoSmithKline R&D), Alexis Henry (Biogen), Caroline Leveder (Sanofi R&D), Mark Richards (Eisai Inc.), Trish Connolly (BioPhorum Development Group) By Joschka Johannes Buyel (Bayer AG), Klaus Kaiser (Bayer AG), Kiran Andra (Alexion), Robert G. ![]()
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