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Application of Quality by Design to the Process Development of Botanical Drug Products: A Case Study
This paper was designed to assess the value of quality by design (QbD) to improve the manufacturing process understanding of botanical drug products. Ethanol precipitation, a widely used unit operation in the manufacture of botanical drug products was employed to illustrate the use of QbD, taking th...
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| Main Authors: | , , , , |
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| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Springer US
2013
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC3581681/ https://ncbi.nlm.nih.gov/pubmed/23297167 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12249-012-9919-8 |
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