Development and Implementation of a Quality Control Strategy for an Atropisomer Impurity Grounded in a Risk-Based Probabilistic Design Space
| العنوان: | Development and Implementation of a Quality Control Strategy for an Atropisomer Impurity Grounded in a Risk-Based Probabilistic Design Space |
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| المؤلفون: | Federico Lora Gonzalez, Jose E. Tabora, Eric C. Huang, Brendan Mack, Steven R. Wisniewski, Thomas M. Razler, Ronald Carrasquillo-Flores |
| المصدر: | Organic Process Research & Development. 23:211-219 |
| بيانات النشر: | American Chemical Society (ACS), 2019. |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | Probabilistic method, Computer science, Organic Chemistry, Probabilistic logic, Critical to quality, Process design, Probabilistic design, Context (language use), Physical and Theoretical Chemistry, Critical quality attributes, Quality by Design, Reliability engineering |
| الوصف: | In the development process of an active pharmaceutical ingredient (API), determination of the design space used for control of critical quality attributes (CQAs) is a key component of the quality by design (QbD) framework outlined by the regulatory agencies. Herein, we propose the use of probabilistic (Bayesian) methods to drive the development of the design space and control strategy for a process. Using probabilistic methods to quantify the risk of failure for different processing options allows for informed process design and control strategy decisions, enabling robust processes. We present a case study of a complex API reaction and crystallization: first, probabilistic models are built using lab and plant data. Next, these models are used to compare different processing options in the context of reliability pertaining to a critical quality attribute (CQA). A process decision is outlined based on the reliability estimates from the models, and last, a control strategy is proposed for the CQA for a defin... |
| تدمد: | 1520-586X 1083-6160 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_________::35ac3d52f43f387bec6d283480ce13c1 https://doi.org/10.1021/acs.oprd.8b00293 |
| حقوق: | CLOSED |
| رقم الأكسشن: | edsair.doi...........35ac3d52f43f387bec6d283480ce13c1 |
| قاعدة البيانات: | OpenAIRE |
Find this issue from the American Chemical Society | تدمد: | 1520586X 10836160 |
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