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

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 assessment, co...

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Bibliographic Details
Published in:Int J Pharm X
Main Authors: Yu, Lawrence X., Raw, Andre, Wu, Larisa, Capacci-Daniel, Christina, Zhang, Ying, Rosencrance, Susan
Format: Artigo
Language:Inglês
Published: Elsevier 2019
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Article
Online Access:https://ncbi.nlm.nih.gov/pmc/articles/PMC6733282/
https://ncbi.nlm.nih.gov/pubmed/31517275
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1016/j.ijpx.2019.100010
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