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The Application of the Accelerated Stability Assessment Program (ASAP) to Quality by Design (QbD) for Drug Product Stability
An isoconversion paradigm, where times in different temperature and humidity-controlled stability chambers are set to provide a fixed degradant level, is shown to compensate for the complex, non-single order kinetics of solid drug products. A humidity-corrected Arrhenius equation provides reliable e...
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| Formato: | Artigo |
| Idioma: | Inglês |
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Springer US
2011
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| Acceso en liña: | https://ncbi.nlm.nih.gov/pmc/articles/PMC3167263/ https://ncbi.nlm.nih.gov/pubmed/21748541 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12249-011-9657-3 |
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