FDA's new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications

• Asıl Yazarlar: Lawrence X. Yu (Yazar), Andre Raw (Yazar), Larisa Wu (Yazar), Christina Capacci-Daniel (Yazar), Ying Zhang (Yazar), Susan Rosencrance (Yazar)
• Materyal Türü: Kitap
• Baskı/Yayın Bilgisi: Elsevier, 2019-12-01T00:00:00Z.
• Konular: article
• Online Erişim: Connect to this object online.

This paper describes a new FDA's pharmaceutical quality assessment system: Knowledge-aided Assessment & Structured Application (KASA). The KASA system is designed to: 1) capture and manage knowledge during the lifecycle of a drug product; 2) establish rules and algorithms for risk assessmen...