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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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Kaydedildi:
Detaylı Bibliyografya
Yayımlandı:AAPS PharmSciTech
Asıl Yazarlar: Alasandro, Mark, Little, Thomas A.
Materyal Türü: Artigo
Dil:Inglês
Baskı/Yayın Bilgisi: Springer US 2015
Konular:
Online Erişim: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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