Digital CMC CERSI Case Studies

Four illustrative case studies showing how the DCRL framework applies to real-world CMC scenarios — covering knowledge-driven, data-driven, and hybrid ML/AI models at different levels of regulatory risk.

Digital CMC CERSI Case Studies
Case Study 1

Digital Polymorph Risk Assessment using Solid Form Informatics Tools and Automated Testing

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Case Study 2

Use of a Hybrid (Knowledge- and Data-Driven ML Models) Model for Predicting the Solubility of an Organic Compound in a Solvent

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Case Study 3

Digital Polymorph Risk Assessment using Solid Form Informatics Tools and Automated Testing

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Case Study 4

Hybrid Digital Modelling Framework for Continuous Direct Compression: Predictive Loss-in-Weight Feeder Models for Soft Sensor Applications

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Funded and supported by the MHRA and the Office for Life Sciences (OLS) managed by Innovate UK with delivery partner Medical Research Council (MRC) the as part of the “RS&IN Implementation Phase: Human Health CERSI” Innovate UK: Project no. 10139447

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