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Clinical Relevance of Dissolution Testing in Quality by Design

Quality by design (QbD) has recently been introduced in pharmaceutical product development in a regulatory context and the process of implementing such concepts in the drug approval process is presently on-going. This has the potential to allow for a more flexible regulatory approach based on unders...

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Hlavní autoři: Dickinson, Paul A., Lee, Wang Wang, Stott, Paul W., Townsend, Andy I., Smart, John P., Ghahramani, Parviz, Hammett, Tracey, Billett, Linda, Behn, Sheena, Gibb, Ryan C., Abrahamsson, Bertil
Médium: Artigo
Jazyk:Inglês
Vydáno: Springer US 2008
Témata:
On-line přístup:https://ncbi.nlm.nih.gov/pmc/articles/PMC2751384/
https://ncbi.nlm.nih.gov/pubmed/18686045
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-008-9034-7
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