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Qualität durch Design (QbD) in der pharmazeutischen Entwicklung

Qualität durch Design (QbD) in der pharmazeutischen Entwicklung

Mukkanti Eswarudu Munnangi / Rafath Sulthana Shaik / Siva Krishna Pusuluri

50,67 €
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Editorial:
KS OmniScriptum Publishing
Año de edición:
2025
Materia
Farmacología
ISBN:
9786208550615
50,67 €
IVA incluido
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Sobre IBD

Quality by Design (QbD) ist ein systematischer Ansatz für die pharmazeutische Entwicklung, bei dem die Qualität von Anfang an in ein Produkt integriert wird, anstatt sich nur auf die Prüfung des Endprodukts zu verlassen. Bei diesem Ansatz geht es darum, die Wissenschaft hinter der Formulierung und den Herstellungsprozessen zu verstehen, kritische Qualitätsattribute (CQAs) zu identifizieren und Prozesse zu entwerfen, die konsistent Produkte liefern, die vordefinierte Qualitätsstandards erfüllen. QbD integriert Risikomanagement, Prozessoptimierung und kontinuierliche Verbesserung während des gesamten Produktlebenszyklus. Es fördert den Einsatz wissenschaftlicher Erkenntnisse, Datenanalysen und Prozesskontrollinstrumente, um die Produktqualität zu verbessern, die Variabilität zu verringern und die Einhaltung von Vorschriften zu gewährleisten. Durch die Konzentration auf Design und Prozessentwicklung zielt QbD darauf ab, die Effizienz der Herstellung sowie die Sicherheit und Wirksamkeit von pharmazeutischen Produkten zu verbessern.

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