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Model-Guided Design Space Development for a Drug Substance Manufacturing Process
2 references·1 citing·8 second hop
Model-Guided Design Space Development for a Drug Substance Manufacturing Process (2011)Model-Guided Design Space Development for…An Example of Utilizing Mechanistic and Empirical Modeling in Quality by Design (2010)An Example of Utilizing Mecha…The Use of Routine Process Capability for the Determination of Process Parameter Criticality in Small-molecule API Synthesis (2008)The Use of Routine Process Ca…Multivariate Analysis and Statistics in Pharmaceutical Process Research and Development (2017)Multivariate Analysis and Sta…Quality by design case study: An integrated multivariate approach to drug product and process development (2009)Scientific, statistical, practical, and regulatory considerations in design space development (2017)Kinetic and Data-Driven Reaction Analysis for Pharmaceutical Process Development (2019)On the Experimental Attainment of Optimum Conditions (1951)Some New Three Level Designs for the Study of Quantitative Variables (1960)Response Surface Methodology: Process and Product Optimization Using Designed Experiments (1996)Application of Safety by Design Methodology in Evaluating Process Safety for a Duff Reaction Using Predictive Process Simulators (2015)An Optimization-Based Framework to Define the Probabilistic Design Space of Pharmaceutical Processes with Model Uncertainty (2019)
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References

  • 2010An Example of Utilizing Mechanistic and Empirical Modeling in Quality by Design37 cited
  • 2008The Use of Routine Process Capability for the Determination of Process Parameter Criticality in Small-molecule API Synthesis24 cited

Cited by

  • 2017Multivariate Analysis and Statistics in Pharmaceutical Process Research and Development25 cited

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