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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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Autore principale: Waterman, Kenneth Craig
Natura: Artigo
Lingua:Inglês
Pubblicazione: Springer US 2011
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Accesso online: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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