Global ETD Search
Search theses and dissertations gathered from participating repositories worldwide. Every result links back to the library that holds it. No account is needed.
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Showing 1 to 20 of 31 for “"Quality by Design"”.
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Quality by design for the downstream processing of biopharmaceuticals
This thesis explores the concept of “Quality by Design” (QbD) as proposed by the FDA and demonstrates how this concept can be used and applied to the manufacture of biopharmaceutical proteins. QbD principles and approaches have been adopted in carrying out the development of unit operations that …
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Developing the business case for Quality by Design in the biopharmaceutical industry
Quality by Design (QbD) is a systematic, science-based approach to pharmaceutical development that was defined in the International Conference on Harmonization (ICH) Q8 guideline in 2005. Expectations are that QbD will ultimately become a regulatory expectation and prerequisite for drug approval. …
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Implementation of the new FDA quality by design guidance in pharmaceutical production
… improved process understanding and product quality in the manufacturing industry. The guidance is aimed at encouraging the use of process analytical technology (PAT) to monitor key quality attributes continuously during the process and enable early fault detection. The goal is to transition …
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Integration of quality-by-design into control systems design for continuous pharmaceutical manufacturing
… there has recently been much interest in design spaces: sets of critical process parameters (CPPs) which guarantee that critical quality attributes (CQAs) of a manufacturing process are within specifications. For continuous pharmaceutical processes, design spaces are usually calculated by …
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Development and manufacture of novel amorphous Itraconazole drug products using quality by design principles
… process analytical technology (PAT) to monitor quality. The solubility parameter () of ITZ and polymers, Kollidon® VA64 (KOL), hydroxypropylmethylcellulose acetate succinate (HPMCAS) and polyvinylacetate (PVA) were screened using group contribution theories developed by Fedors, Van Krevelen and …
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Solubility Enhancement via Melt Extrusion: Drug-polymer Solubility, Physicochemical Characterization and Quality by Design
… dispersions. This has been further extended by in depth thermal and chemical characterization of the ibuprofen and Eudragit<super>®</super> E PO system. A phase diagram is predicted based on the understanding of the relationship between temperature, ratio of ibuprofen and the Gibbs free …
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Aplicação de quality by design no estudo de pré-formulação farmacêutica do sulfato de hidroxicloroquina
… com o sulfato de HCQ utilizando o conceito de Quality by Desing (QbD), como etapa limitante para o desenvolvimento de formas farmacêuticas. A caracterização da matéria-prima foi realizada através de diferentes técnicas analíticas, a fim de gerar robusta carta de identidade do fármaco. Devido à …
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Engineering Biomaterials using Quality by Design for the delivery of Ibuprofen for use in Cardiovascular therapy
… via Electrohydrodynamic atomisation (EHDA). The Quality by Design (QBD) process was carried out prior to loading in order to identify optimum parameters (flow rate, voltage, distance from the needle to the platform) in the EHDA technique. All formulations were found to hold ideal viscosity, …
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Quality by Design Approach to Advanced Particle Engineering, Process Optimisation and Upscaling of Electrohydrodynamic Atomisation Technology
… promising technology. This was first achieved by the utilisation of the EHDA technique in the nanofabrication of indomethacin (INDO) crystal, with the intention of achieving nanocrystals with sustained or improved particle properties for DD. QbD technique was used in the optimisation of the …
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MANUFACTURE OF INDIVIDUALIZED DOSING: DEVELOPMENT AND CONTROL OF A DROPWISE ADDITIVE MANUFACTURING PROCESS FOR MELT BASED PHARMACEUTICAL PRODUCTS
… and Drug Administration (FDA) introduced the Quality by Design (QbD) and Process Analytical Technology (PAT) guidelines to encourage innovation and efficiency in pharmaceutical development, manufacturing and quality assurance. As a result of emerging technologies and encouragement from the …
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Performance-Based Quality Specifications: The Link between Product Development and Clinical Outcomes
The design of drug delivery systems and their corresponding dosing guidelines are critical product development functions supported by clinical pharmacokinetic (PK) and pharmacodynamic (PD) data. Largely, the importance of variance and covariance in product and patient attributes is poorly …
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Microstructural investigation of tablet compaction and tablet pharmacological properties
… a barrier to rational formulation / process design. In this study, it was hypothesized that the understanding of tablet microstructure is pivotal in bridging our knowledge about the materials, the manufacturing process, and the tablet properties. A series of X-ray micro computed tomography …
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Continuous Antibody Titer Assessment of the Biomanufacturing Process using Nanofluidic Binding Assays
… and production enables the implementation of quality-by-design biomanufacturing, rapid bioprocess decision-making, and process optimization. Intermittent sampling and analysis are presently utilized to maintain long-term perfusion culture. However, this increases the risk of introducing …
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Ensuring analytical quality in regulated markets through multivariate, multiway and DoE strategies
… el paradigma de la Calidad por el Diseño (Quality by Design, QbD) al laboratorio.
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Advanced Electrohydrodynamic Atomisation Engineered Microneedle Coatings
… was carried out. This was followed by Quality by Design (QBD) implementation for the optimisation of the key process parameters in EHDA. Here, the electrosprayed nanoparticles and electrospun nano/micro fibres consisted of a polymeric matrix and dye. Eight formulations were assessed …
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Design and development of polymeric nanoparticles by continuous manufacture using twin screw extrusion
… projected to be worth US$369.5 Billion by 2027 (Research and Market, 2020). Despite this, there is a significant lack of nanoparticles in the clinic; the ability to produce polymeric nanoparticles, reproducibly, and on a large scale remains a challenge. As a manufacturing tool, extrusion …
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Hot-melt extrusion: A versatile pharmaceutical technology
… systems via hot-melt extrusion (HME) using Quality by Design (QbD) principles. Fenofibrate SLN were prepared by combining two processes: HME technology for melt-emulsification and high-pressure homogenization (HPH) for size reduction. Varying the process parameters enabled the production of …
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Application of First Principle Modeling in Combination with Empirical Design of Experiments and Real-Time Data Management for the Automated Control of Pharmaceutical Unit Operations
… has accepted the guidelines put forth by the International Conference on Harmonization (ICH-Q8) that allow for operational flexibility within a validated design space. These Quality by Design initiatives have allowed drug manufacturers to incorporate more rigorous scientific controls …
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Hydrogen Sulfide in Glaucoma: Delivery System, Hypotensive and Neuroprotective Effects
… is an optic neuropathy disorder characterized by progressive degeneration of retinal ganglion cells (RGCs). More than 80 million people, including 3 million Americans, have glaucoma. Increased intraocular pressure (IOP) is a distinct marker of glaucoma. IOP in glaucoma increases from the …
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Melt extrusion and continuous manufacturing of pharmaceutical materials
… has the potential to achieve tablets of better quality and consistency compared to traditional methods. Thus, our goal was to evaluate melt extrusion as a viable processing alternative and expand our scientific knowledge such that we gain predictive capabilities of tablet characteristics, i.e., …
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