De-risking Pharmaceutical Tablet Manufacture Through Process Understanding, Latent Variable Modeling, and Optimization Technologies

In pharmaceutical tablet manufacturing processes, a major source of disturbance affecting drug product quality is the (lot-to-lot) variability of the incoming raw materials. A novel modeling and process optimization strategy that compensates for raw material variability is presented. The approach in...

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Veröffentlicht in:AAPS PharmSciTech 2011-12, Vol.12 (4), p.1324-1334
Hauptverfasser: Muteki, Koji, Swaminathan, Vidya, Sekulic, Sonja S., Reid, George L.
Format: Artikel
Sprache:eng
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