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Bibliographies thématiques / Analytical Quality by Design (aQbD) / Thèses

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Thèses sur le sujet « Analytical Quality by Design (aQbD) »

Auteur : Grafiati

Publié le 7 juin 2025

Mis à jour le 2 août 2025

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1

Gola, Benjamin [Verfasser]. "Quality by design and process analytical technology zur Herstellung bioaktiver Proteine / Benjamin Gola." Hannover : Technische Informationsbibliothek (TIB), 2016. http://d-nb.info/1126666300/34.

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2

Ruflin, Justin 1981. "Analytical techniques of quality and cost : robust design, design of experiments, and the prediction of mean shift." Thesis, Massachusetts Institute of Technology, 2004. http://hdl.handle.net/1721.1/32782.

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Thesis (S.B.)--Massachusetts Institute of Technology, Dept. of Mechanical Engineering, 2004.<br>Includes bibliographical references (leaf 50).<br>The quality of a product to a large extent determines the success of that product in competitive markets. Measuring and improving quality is thus a primary objective of the designer. The aim of the following work is to provide an introduction to the methods of quality optimization and to illustrate these techniques through examples. Quality is first defined and quantified. The robust design method, which is a technique that focuses on improving quali

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Smith, Michael E. "Method Development for On-Site Air Quality Analysis and Design of Hydrogen Sensors for Orthopedic Applications." University of Cincinnati / OhioLINK, 2020. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1583999801696302.

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4

Lindfeldt, Olov. "Railway operation analysis : Evaluation of quality, infrastructure and timetable on single and double-track lines with analytical models and simulation." Doctoral thesis, KTH, Trafik och Logistik, 2010. http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-12727.

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This thesis shows the advantages of simple models for analysis of railway operation. It presents two tools for infrastructure and timetable planning. It shows how the infrastructure can be analysed through fictive line designs, how the timetable can be treated as a variable and how delays can be used as performance measures. The thesis also gives examples of analyses of complex traffic situations through simulation experiments. Infrastructure configuration, timetable design and delays play important roles in the competitiveness of railway transportation. This is especially true on single-track

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5

Åsberg, Dennis. "Fundamental and Regulatory Aspects of UHPLC in Pharmaceutical Analysis." Doctoral thesis, Karlstads universitet, Institutionen för ingenjörs- och kemivetenskaper, 2017. http://urn.kb.se/resolve?urn=urn:nbn:se:kau:diva-47852.

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Ultra-high performance liquid chromatography (UHPLC) provides a considerable increase in throughput compared to HPLC and a reduced solvent consumption. The implementation of UHPLC in pharmaceutical analysis, e.g. quality control, has accelerated in recent years and there is currently a mix of HPLC and UHPLC instrumentation within pharmaceutical companies. There are, however, technical and regulatory challenges converting a HPLC method to UHPLC making it difficult to take full advantage of UHPLC in regulatory-focused applications like quality control in pharmaceutical production. Using chromato

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6

Schaefer, Cédric. "A Process Analytical Technology (PAT) approach involving near infrared spectroscopy to control the manufacturing of an active pharmaceutical ingredient : development, validation and implementation." Thesis, Aix-Marseille, 2013. http://www.theses.fr/2013AIXM4375.

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Les entreprises pharmaceutiques ont progressivement adopté le concept de Process Analytical Technology (PAT) afin de contrôler et d'assurer en temps réel la qualité des produits pharmaceutiques au cours de leur production. Le PAT et un composant central du concept plus général de Quality-by-Design (QbD) promu par les agence régulatrices et visant à construire la qualité des produits via une approche scientifique et la gestion des risques.Une méthode basée sur la spectroscopie proche infrarouge (PIR) a été développée comme un outil du PAT pour contrôler en ligne la cristallisation d'un principe

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7

BOBBA, SERENA. "Near-Infrared Spectroscopy for Freeze-Drying: Applications for Pharmaceuticals." Doctoral thesis, Politecnico di Torino, 2022. http://hdl.handle.net/11583/2957736.

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8

Fukuda, Isa Martins. "Desenvolvimento e otimização de protetores solares empregando os conceitos de qualidade por design (QbD) e tecnologia analítica de processos (PAT)." Universidade de São Paulo, 2018. http://www.teses.usp.br/teses/disponiveis/9/9139/tde-12112018-145821/.

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Os protetores solares (PS) são os grandes responsáveis pela proteção da pele quando exposta à radiação solar, por isso a importância sanitária de se otimizar o desenvolvimento deste cosmético tipo II e monitorar para que seja eficaz em seu propósito. O principal objetivo deste trabalho é aplicar os conceitos de Qualidade por Design (QbD), ferramentas estatísticas de desenho experimental (DoE - Design of Experiments) e o conceito de tecnologia analítica de processo (PAT - Process Analytical Technology) para desenvolver uma formulação e processo produtivo de um PS de modo a modernizar os process

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9

Yekpe, Kétsia. "Relier les attributs de matériaux et les paramètres de procédés de fabrication à un test de contrôle qualité, une application du concept du quality by design." Thèse, Université de Sherbrooke, 2014. http://hdl.handle.net/11143/5397.

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Résumé : À partir de 2002, grâce à l’introduction du concept de la Qualité par la Conception (en anglais Quality by Design : QbD) par l’agence américaine des produits alimentaires et médicamenteux, l’industrie pharmaceutique a intensifié les efforts et les investissements pour permettre une libération en temps réel des lots commerciaux. Le QbD propose que la qualité soit construite dès la conception initiale du médicament plutôt que d'être évaluée à la fin de sa fabrication. Ainsi, avec l’initiative QbD, les tests de contrôle de la qualité des médicaments, réalisés après la fabrication des com

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10

Lima, Clarissa Sucupira Andrade. "The use of formal methods for decision making in the planning phase of healthcare facilities." Thesis, Available online, Georgia Institute of Technology, 2007, 2007. http://etd.gatech.edu/theses/available/etd-04042007-211547/.

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11

Morganti, Mattia. "Studio di parametri critici per la miscelazione di polveri ad uso farmaceutico." Master's thesis, Alma Mater Studiorum - Università di Bologna, 2018.

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Negli ultimi 15 anni si è iniziato a considerare utile e necessario, nell’ambito dell’industria farmaceutica, un miglior controllo dei processi produttivi, al fine di migliorare l’efficienza degli stessi e, contestualmente, diminuire i rischi per i pazienti; per questi motivi, l’ente governativo statunitense Food and Drug Administration (FDA) ha iniziato, a sostenere l’uso della cosiddetta Process Analytical Technology (PAT) nell’ambito dello sviluppo e della produzione di farmaci. La PAT sostenuta dall’FDA rappresenta un insieme di metodi e tecnologie utili per progettare, analizzare e contr

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12

Gazda, Daniel Bryan. "Development of colorimetric solid Phase Extraction (C-SPE) for in-flight Monitoring of spacecraft Water Supplies." Washington, D.C. : Oak Ridge, Tenn. : United States. Dept. of Energy. Office of Science ; distributed by the Office of Scientific and Technical Information, U.S. Dept. of Energy, 2004. http://www.osti.gov/servlets/purl/835309-K3fMzj/webviewable/.

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13

Schaefer, Cédric. "A Process Analytical Technology (PAT) approach involving near infrared spectroscopy to control the manufacturing of an active pharmaceutical ingredient : development, validation and implementation." Electronic Thesis or Diss., Aix-Marseille, 2013. http://www.theses.fr/2013AIXM4375.

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Les entreprises pharmaceutiques ont progressivement adopté le concept de Process Analytical Technology (PAT) afin de contrôler et d'assurer en temps réel la qualité des produits pharmaceutiques au cours de leur production. Le PAT et un composant central du concept plus général de Quality-by-Design (QbD) promu par les agence régulatrices et visant à construire la qualité des produits via une approche scientifique et la gestion des risques.Une méthode basée sur la spectroscopie proche infrarouge (PIR) a été développée comme un outil du PAT pour contrôler en ligne la cristallisation d'un principe

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14

Maranho, Rafael Finocchiaro. "Desenvolvimento de um método indicativo de estabilidade para ondansetrona." Universidade de São Paulo, 2017. http://www.teses.usp.br/teses/disponiveis/46/46137/tde-14122017-144542/.

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ultravioleta e espectrometria de massas para análise do teor e limite de impurezas e compostos de degradação para o principio ativo farmacêutico ondansetrona e três diferentes formas farmacêuticas foi desenvolvido utilizando conceitos de qualidade analítica por planejamento (aQbD) e validado de acordo com os requerimentos da USP-NF e do ICH. O método desenvolvido apresentou capacidade de separação de vinte compostos detectados nas amostras envolvidas no estudo: o princípio ativo ondansetrona, sete impurezas descritas nos principais compêndios farmacopéicos mundiais (United States Pharmacopeia-

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15

Chvatík, Štěpán. "Asynchronní motor s vnějším rotorem." Master's thesis, Vysoké učení technické v Brně. Fakulta elektrotechniky a komunikačních technologií, 2018. http://www.nusl.cz/ntk/nusl-377075.

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16

Luca, Nompari. "Designing Quality: Quality by Design in the analytical pharmaceutical development." Doctoral thesis, 2018. http://hdl.handle.net/2158/1116278.

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The present thesis study describes an integrated approach for the implementation of Quality by Design principles to screening and development of analytical methods applied to vaccines physical-chemical testing, according to Analytical QbD (AQbD) published in literature. The research study is focused on application of the risk assessment and the experimental design tools to be used to build knowledge about the analytical methods performance and to mitigate the risks of failure. Risk management tools and mathematical/statistical models have been applied to study and define well characterized an

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Gaspar, Joana Rita Mendes. "Analytical Quality By Design To Characterize Inhalation Products." Master's thesis, 2018. http://hdl.handle.net/10316/84554.

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Dissertação de Mestrado em Biotecnologia Farmacêutica apresentada à Faculdade de Farmácia<br>O presente trabalho foi baseado no desenvolvimento de um método analítico utilizando a abordagem de Analytical Quality by Design (AQbD). Esta abordagem é utilizada quando existe a necessidade de se obter um conhecimento completo do método e, ao mesmo tempo, controlar os possíveis fatores que podem influenciar os resultados no trabalho de rotina. O método analítico escolhido foi o Next Generation Impactor (NGI) que tem a capacidade de avaliar a distribuição aerodinâmica do tamanho de partícula de um aer

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18

Lourenço, Ana Sofia da Costa. "Quality by design and process analytical technology for drug delivery nanosystems : overcoming quality and regulatory concerns." Master's thesis, 2015. http://hdl.handle.net/10451/27019.

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19

Oryall, Jeffrey John. "Design of statistical quality control procedures for multi-test clinical analytical systems." 1988. http://catalog.hathitrust.org/api/volumes/oclc/18171722.html.

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Thesis (M.S.)--University of Wisconsin--Madison, 1988.<br>Typescript. eContent provider-neutral record in process. Description based on print version record. Includes bibliographical references (leaves 101-102).

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20

Anacleto, Beatriz Casimiro Soares. "Determination of residual solvents in pharmaceuticals: development of a general analytical method applying Quality by Design." Master's thesis, 2018. http://hdl.handle.net/10773/25630.

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The presence of residual solvents in pharmaceuticals represents one of the main concerns of the pharmaceutical industry due to its impact on both products’ properties and patients’ health. For these reasons, it is necessary to develop analytical strategies that support the decision making process in each stage of the pharmaceutical development and simultaneously maximize the efficiency and productivity of the laboratory responsible for pharmaceutical quality control. In this thesis, a general Static Headspace-Gas Chromatography method was developed applying the Analytical Quality by Design (A

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21

Rodrigues, Inês Sofia Baptista. "Implementation of Quality-by-design in drug development: continuous manufacturing." Master's thesis, 2016. http://hdl.handle.net/10451/35845.

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Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, Universidade de Lisboa, Faculdade de Farmácia, 2016<br>Pharmaceutical manufacturing has been changing over the last years, especially, due to significant advances in science and engineering. The lack of flexibility, quality consistency, robustness of manufacturing, the need to respond faster to market shortage and the necessity of better process control demanded the establishment of new technologies, such as Process Analytical Technology (PAT), Quality by Design (QbD) and, more recently, Continuous Pharmaceutical Manufacturing (CPM

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22

Marques, Ana Rita Lopes. "‘Aplicação de “Quality by Design” no desenvolvimento de um método analítico para quantificação de substância ativa numa forma farmacêutica sólida oral de libertação imediata em ensaios de dissolução’." Master's thesis, 2018. http://hdl.handle.net/10316/84573.

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Dissertação de Mestrado em Tecnologias do Medicamento apresentada à Faculdade de Farmácia<br>A presente dissertação teve o objectivo de desenvolver um método analítico através do quality-by-design, com posterior pré-validação para quantificação de substância ativa de uma forma farmacêutica sólida oral de libertação imediata de amostras provenientes de ensaios de dissolução. O método analítico foi desenvolvido em Cromatografia Líquida de Alta Eficiência (HPLC-UV), e foi feita uma abordagem QbD de forma a desenvolver um método mais robusto. Este estudo recorre a modelos estatísticos e a desenho

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biagi, diletta. "Application of Quality by Design and innovative technologies to the production and control of pharmaceutical dosage forms." Doctoral thesis, 2022. http://hdl.handle.net/2158/1266556.

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The presented project consisted in the application of Quality by Design (QbD) and its principles to the manufacturing process of bilastine tablets. The manufacturing process of bilastine tablets has already been developed and it is currently used for manufacturing of commercial product. The present work was not aimed at criticizing the previous process development; rather, it was intended to acquire an increased knowledge and understanding, in order to better control the steps of the process and to assure a constant quality of the final product. More and more often international authorities

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Zacour, Brian. "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." 2012. http://digital.library.duq.edu/u?/etd,154103.

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The U.S. Food and Drug Administration 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 into their production streams. <br>Fully automated control systems can incorporate information about a process back into the system to adjust process variables to consistently hit product quality targets (feedback control), or monitor variability in raw materials or inte

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25

Cordeiro, Pedro Miguel António. "Evaluation of the cost-benefit of the implementation of PAT systems for the production of solid forms in a pharmaceutical company." Master's thesis, 2016. http://hdl.handle.net/10451/28420.

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Tese de mestrado, Engenharia Farmacêutica, Universidade de Lisboa, Faculdade de Farmácia, 2016<br>Process Analytical Technology (PAT) is defined by the FDA in the PAT initiative issued in 2004 as ”a system for designing, analyzing, and controlling manufacturing through timelymeasurements (i.e.,during processing) of critical quality and performance attributes of raw and inprocess materials and processes, with the goal of ensuring the final product quality”. Since then, the pharmaceutical companies have been adopting gradually this technology in their manufacturing lines. PAT tools are indeed we

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