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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...
| Autores principales: | , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Elsevier
2019
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6733282/ https://www.ncbi.nlm.nih.gov/pubmed/31517275 http://dx.doi.org/10.1016/j.ijpx.2019.100010 |