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Quality by Design Considerations
2019Quality by design has been both a development and regulatory objective since the turn of the Millennium. Inhaled medicines are complex products for which each component requires scrutiny with respect to impact on the important performance measures of delivered dose and aerodynamic particle size.
William Craig Stagner, Anthony J. Hickey
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Quality by Design: Concept to Applications
Current Drug Discovery Technologies, 2019Background: Quality by Design (QbD) is associated with a modern, systematic, scientific and novel approach which is concerned with pre-distinct objectives that not only focus on product, process understanding but also lead to process control. It predominantly signifies the design and product improvement and the manufacturing process in order to ...
Suryakanta, Swain +3 more
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Quality by Experimental Design
Technometrics, 1986John Disney, T. B. Barker
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Analytical development is considered as an integral part of the pharmaceutical product life-cycle, where establishment of an effective, cost-effective, robust, sensitive, and specific analytical methods are always required for analysis of drug(s), degradation product(s), and impurities in dosage forms. As analytical method development involves a series
O. S. Bilone +4 more
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O. S. Bilone +4 more
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Quality cell therapy manufacturing by design
Nature Biotechnology, 2016Transplantation of live cells as therapeutic agents is poised to offer new treatment options for a wide range of acute and chronic diseases. However, the biological complexity of cells has hampered the translation of laboratory-scale experiments into industrial processes for reliable, cost-effective manufacturing of cell-based therapies.
Yonatan Y Lipsitz +2 more
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Aceclofenac microspheres: Quality by design approach
Materials Science and Engineering: C, 2014The purpose of this study was to prepare polymeric microspheres containing aceclofenac by single emulsion [oil-in-water (o/w)] solvent evaporation method. Two biocompatible polymers, ethylcellulose, and Eudragit® RS100 were used in combination.
Rameshwar K, Deshmukh, Jitendra B, Naik
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QUALITY BY DESIGN IN ANALISI FARMACEUTICA
La Chimica e l'Industria online, 2018L’approccio Quality by Design è stato applicato allo sviluppo di un metodo CZE con aggiunta di ciclodestrina per la determinazione della purezza enantiomerica e delle impurezze del farmaco calciomimetico cinacalcet. L’uso combinato di varie tecniche analitiche ha consentito di studiare i meccanismi di separazione e di comprendere le interazioni ...
B. Pasquini, S. Orlandini, S. Furlanetto
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Pharmaceutical quality by design: Quality by design approach and its elements
2010Quality by Design (QbD) is a modern approach of pharmaceutical development. It means building quality in product during whole development to ensure predefined targets. Implementing QbD, enhances product quality and productivity. This review defines QbD approach and its elements.
Yüce M., Çapan Y.
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Journal of Planning Education and Research, 2003
This article examines the gradual emergence of an integrated technological and behavioral approach to mobile source emissions control in the United States. Confronted with the persistence of urban air quality problems in regions experiencing rapid population growth and decentralization, the Environmental Protection Agency recently developed a set of ...
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This article examines the gradual emergence of an integrated technological and behavioral approach to mobile source emissions control in the United States. Confronted with the persistence of urban air quality problems in regions experiencing rapid population growth and decentralization, the Environmental Protection Agency recently developed a set of ...
openaire +1 more source