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Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics
Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design). It allo...
| Autores principales: | , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Hindawi Publishing Corporation
2015
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4332986/ https://www.ncbi.nlm.nih.gov/pubmed/25722723 http://dx.doi.org/10.1155/2015/868727 |