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- W4384786742 abstract "A biopharmaceutical manufacturer might submit a DS definition as part of the regulatory approval application, in which case process parameter (PP) deviations within this space are not considered a change and do not trigger a regulatory post approval procedure. While several methods exist for finding a DS described by non-linear PP ranges, here we introduce a novel method for finding linear combinations – a DS definition often preferred due to its operational simplicity. We use a numeric optimizer to find the design space with the largest parameter space volume that results in critical quality attribute (CQA) boundaries within acceptance criteria, predicted by a regression model. A precomputed approximation of tolerance intervals is used in inequality constraints to facilitate fast evaluations of this boundary using a single matrix multiplication. Correctness of the method was validated against different ground truths with known design spaces." @default.
- W4384786742 created "2023-07-20" @default.
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- W4384786742 date "2023-01-01" @default.
- W4384786742 modified "2023-09-26" @default.
- W4384786742 title "A Method for Finding a Design Space as Linear Combinations of Parameter Ranges for Biopharmaceutical Development" @default.
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- W4384786742 doi "https://doi.org/10.1016/b978-0-443-15274-0.50145-1" @default.
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