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- W2950574877 abstract "This article proposes to pursue advanced statistical approaches to quantify risks systematically through a product lifecycle for sound decision making. The work focuses on registered specifications and internal release limits as these are important elements in pharmaceutical development, manufacturing, and supply to ensure product safety, efficacy, and quality. Bayesian inference is explored as a potential valuable approach to enhance risk assessment and related decision making. A Bayesian approach is utilized to predict risks of batch failure and poor process capability associated with registered specifications and internal release limits, leading to a more effective specification setting process. The benefits are demonstrated using a real-life case." @default.
- W2950574877 created "2019-06-27" @default.
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- W2950574877 date "2019-01-01" @default.
- W2950574877 modified "2023-09-23" @default.
- W2950574877 title "Risk Evaluation of Registered Specifications and Internal Release Limits Using a Bayesian Approach" @default.
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- W2950574877 doi "https://doi.org/10.1007/978-3-319-67386-8_7" @default.
- W2950574877 hasPublicationYear "2019" @default.
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