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 16 of 16 for “"Quality by design (QbD)"”.
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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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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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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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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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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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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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Effects of Polymers on Carbamazepine cocrystals phase transformation and release profiles
… acid (CBZ-CIN) cocrystals, were synthesized. A Quality by Design (QbD) approach was used to construct the formulation. Dissolution and solubility were studied using UV imaging and High Performance Liquid Chromatography (HPLC). The polymorphic transitions of cocrystals and crystalline properties …
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Process analytical technology in tablet manufacturing
… and used as process monitoring following by quality by design (QbD) concept. It has been applied to the pharmaceutical manufacturing especially in every step of tablet production until final product in order to ensure the product quality. Otherwise, it would be an essential part of a …
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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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Using an In Vitro-In Vivo Correlation for the ‘Bioequivalence by Design’ Development of an Immediate Release Carbamazepine Product
<p>The quality of a drug product may be characterized by the consistency with which its indicated clinical effect, and safety profile, is experienced by the patient. The concept that such quality should be built into a product is at the core of the United States Food and Drug Administration’s (FDA) …
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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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Design of nanoplatforms for ocular delivery of SIRT1 agonists in diabetic retinopathy [Progettazione di nanopiattaforme per la somministrazione oculare di agonisti di SIRT1 nella retinopatia diabetica]
… sono stati progettati seguendo la metodologia Quality by Design (QbD). In particolare, è stato utilizzato il software Design of Experiment (DoE) per ottimizzare i sistemi lipidici al fine di ottenere formulazioni con parametri adeguati alla somministrazione oculare. I primi sistemi indagati …
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Inter-Grade and Inter-Batch Variability of Pharmaceutical-Grade Sodium Alginate
… of this dissertation work is to facilitate the quality-by-design (QbD) approach to pharmaceutical formulation and manufacturing by evaluating the inter-grade and inter-batch variability of pharmaceutical-grade polymeric excipients. Sodium alginate, a widely used polymeric excipient, was selected …
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Espacio de diseño con métodos de inversión de modelos de regresión sobre variables latentes
… de Procesos (PAT) y la Calidad Diseñada (QbD) definen un contexto más allá del modelado matemático puro de un proceso. Se desarrolla una alternativa novedosa para la inversión de modelos predictivos del tipo PLS (Partial Least Squares) mediante un procedimiento computacional basado en …