Robustness Optimization of an Existing Tablet Coating Process Applying Retrospective Knowledge (rQbD) and Validation

The objective of these studies is to verify and validate the improvement in the inter-tablet coating uniformity for an industrially commercialized coated tablet, without involving changes in the approved registration dossier. Using the CPP (critical process parameters) determined from previous retro...

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主要な著者:	Albert Galí, Magda Ascaso, Anna Nardi-Ricart, Marc Suñé-Pou, Pilar Pérez-Lozano, Josep M. Suñé-Negre, Encarna García-Montoya
フォーマット:	Artigo
言語:	Inglês
出版事項:	MDPI AG 2020-08-01
シリーズ:	Pharmaceutics
主題:	retrospective data design of experiments critical process parameters coating optimization coating defects process validation
オンライン･アクセス:	https://www.mdpi.com/1999-4923/12/8/743
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