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

• Main Authors: Lawrence X. Yu (Author), Andre Raw (Author), Larisa Wu (Author), Christina Capacci-Daniel (Author), Ying Zhang (Author), Susan Rosencrance (Author)
• Format: Book
• Published: Elsevier, 2019-12-01T00:00:00Z.
• Subjects: article
• Online Access: 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...