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Application of QbD Principles for the Evaluation of Empty Hard Capsules as an Input Parameter in Formulation Development and Manufacturing

机译：QbD原理在配方开发和制造中评估空硬胶囊作为输入参数的应用

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1. Application of the QbD Principles in the Development of the Casopitant Mesylate Manufacturing Process. Process Research Studies for the Definition of the Control Strategy of some Drug Substance-CQAs for Stages 2a, 2b, and 2c [J] . Zadeo Cimarosti, Fernando Bravo, Damiano Castoldi Organic process research & development . 2010,第4期

机译：QbD原理在甲磺酸卡波替丁生产工艺开发中的应用。定义2a，2b和2c阶段某些药物CQA控制策略的过程研究
2. Development of a Dynamic Kinetic Resolution for the Isolation of an Intermediate in the Synthesis of Casopitant Mesylate: Application of QbD Principles in the Definition of the Parameter Ranges, Issues in the Scale-Up and Mitigation Strategies [J] . Fernando Bravo, Zadeo Cimarosti, Francesco Tinazzi Organic process research & development . 2010,第5期

机译：动态动力学分辨率的发展，以分离甲磺酸卡波替丁合成中的中间体：QbD原理在参数范围定义，规模扩大和缓解策略中的应用
3. Introduction to the application of QbD principles for the development of monoclonal antibodies [J] . Finkler Christof, Krummen Lynne Biologicals: Journal of the International Association of Biological Standardization . 2016,第5期

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4. APPLICATION OF QUALITY BY DESIGN (QBD) PRINCIPLES TO EXTRACTABLES/LEACHABLES ASSESSMENT: ESTABLISHING A DESIGN SPACE FOR TERMINALLY STERILIZED AQUEOUS DRUG PRODUCTS STORED IN PLASTIC PACKAGING SYSTEM [C] . Dennis Jenke Rapra International Conference on Blowing Agents and Foaming Processes . 2011

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5. 1. Development of hot-melt pan-coating, application to sustained-release capsules and tamper resistant-coating. 2. Formulation of verapamil hydrogen chloride and diltiazem hydrogen chloride semisolid matrix capsules. 3. Novel sustained release tablet of glipizide: Compression of coated drug beads, formulation, dissolution, and convolution. 4. Verapamil sustained release: New formulation and convolution. [D] . Nguyen, Chien Ngoc. 2006

机译：1.开发热熔性包衣，应用于缓释胶囊和防篡改包衣。 2.配制维拉帕米氯化氢和地尔硫卓氯化氢半固体基质胶囊。 3.格列吡嗪的新型缓释片剂：包衣药物珠的压缩，制剂，溶解和卷积。 4.维拉帕米缓释剂：新配方和卷积剂。
6. Application of QbD Principles for the Evaluation of Empty Hard Capsules as an Input Parameter in Formulation Development and Manufacturing [O] . Sven Stegemann, Paul Connolly, Wayne Matthews, 2014

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7. Formulation Development and Evaluation of New Albendazole Tablets with Integrated Quality by Design (QbD) Approach [O] . Dnyaneshwar G Sitre, Ravindra K. Kamble 2021

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Application of QbD Principles for the Evaluation of Empty Hard Capsules as an Input Parameter in Formulation Development and Manufacturing

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