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1. Tablet Quality-Prediction Model Using Quality Material Attributes: Toward Flexible Switching Between Batch and Continuous Granulation

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   09 Jun 2023 | Contributor(s):: Arai, H, Nagato, TKoide, T, Yonemochi, E, Yamamoto, H, Sugiyama, H

   Purpose The purpose of the study was to develop a model to predict the critical quality attribute (CQA) of tablets during continuous and batch manufacturing using only critical material attributes (CMAs). Methods Experiments were performed using ethenzamide as the active pharmaceutical ingredient...

2. Supervised Extended Iterative Optimization Technology for Estimation of Powder Compositions in Pharmaceutical Applications: Method and Lifecycle Management

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   09 Jun 2023 | Contributor(s):: Muñoz, Salvador García, Torres, Eduardo Hernández

   Further enhancements to the extended iterative optimization technology (EIOT) method are presented. These are meant to include the effects of nonchemical interferences of known origin in the EIOT parameters and to manage the lifecycle of the method in a pharmaceutical manufacturing application. A...