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Power of the Dissolution Test in Distinguishing a Change in Dosage Form Critical Quality Attributes
For a dissolution method to be considered relevant to in vivo performance, the dissolution data profiles should show discrimination or meaningful change when there is a change in critical material attributes (CMAs) and critical product properties (CPPs). The dissolution test has been shown repeatedl...
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Springer International Publishing
2018
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6848239/ https://www.ncbi.nlm.nih.gov/pubmed/30350251 http://dx.doi.org/10.1208/s12249-018-1197-7 |