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Process and Method Variability Modeling to Achieve QbD Targets
A statistical modeling tool is presented that enables real-time viewing of how changes in method, process, and stability variability/bias impact product acceptance rate. The tool can be used to set and justify specifications. As needed, additional sources of variability/bias can be added to further...
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| Опубликовано в: : | AAPS PharmSciTech |
|---|---|
| Главные авторы: | , |
| Формат: | Artigo |
| Язык: | Inglês |
| Опубликовано: |
Springer US
2015
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| Предметы: | |
| Online-ссылка: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4984887/ https://ncbi.nlm.nih.gov/pubmed/26265189 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12249-015-0380-3 |
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