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PAT in pharmaceutical process optimization as support for QbD in final drug product manufacturing(PPT)

机译:制药工艺优化中的PAT支持最终药品制造(PPT)中的QbD

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摘要

1. PAT may be seen as a hurdle, but some PAT tools or the way they can be used may make them easier to implement in development 2. PAT allows to monitor the "path" the process is following. No control of quality at the end of the process but "build in quality" at any time point 3. During QbD development DoEs require to have a better understanding of the happenings and insight in the drug product. 4. Additional tools such as imaging technologies deployed during development help defining the right PAT tool and interpretation of the results.
机译:1. PAT可能被视为一个障碍,但是某些PAT工具或它们的使用方式可能会使它们在开发中更容易实现。2. PAT允许监视过程遵循的“路径”。在过程结束时,无法控制质量,而在任何时间点都可以“建立质量”。3.在QbD开发过程中,DoE必须更好地了解药品的发生情况和洞察力。 4.开发期间部署的成像技术等其他工具可帮助定义正确的PAT工具并解释结果。

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