کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2503180 | 1557422 | 2011 | 8 صفحه PDF | دانلود رایگان |

A comprehensive Quality by Design development paradigm should consider the impact of raw materials and formulation on the final drug product. This work proposes a quantitative approach to simultaneously predict particle, powder, and compact mechanical properties of a pharmaceutical blend, based on that of the raw materials. A new, two-step, multivariate modeling method, referred to as the weighted scores PLS, was developed to address the challenge of predicting the properties of a powder blend while enabling process understanding. The model validation exercise is shown along with selected practical applications. It is shown how the proposed in-silico model exhibits sufficient predictive power to be an important tool in the pharmaceutical development decision making process while requiring minimal experimentation and material usage.
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Journal: International Journal of Pharmaceutics - Volume 418, Issue 2, 14 October 2011, Pages 235–242