Academic literature on the topic 'Process analytical technologies (PAT)'

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Journal articles on the topic "Process analytical technologies (PAT)"

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Patel, Sajal Manubhai, and Michael Pikal. "Process Analytical Technologies (PAT) in freeze-drying of parenteral products." Pharmaceutical Development and Technology 14, no. 6 (November 3, 2009): 567–87. http://dx.doi.org/10.3109/10837450903295116.

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Hinz, Dirk C. "Process analytical technologies in the pharmaceutical industry: the FDA’s PAT initiative." Analytical and Bioanalytical Chemistry 384, no. 5 (August 4, 2005): 1036–42. http://dx.doi.org/10.1007/s00216-005-3394-y.

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Grumbach, Carsten, and Peter Czermak. "Process Analytical Technology for the Production of Parenteral Lipid Emulsions According to Good Manufacturing Practices." Processes 10, no. 6 (June 10, 2022): 1174. http://dx.doi.org/10.3390/pr10061174.

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The good manufacturing practices (GMP) and process analytical technology (PAT) initiatives of the US Food and Drug Administration, in conjunction with International Council for Harmonisation (ICH) quality guidelines Q8, Q9, and Q10, ensure that manufacturing processes for parenteral formulations meet the requirements of increasingly strict regulations. This involves the selection of suitable process analytics for process integration and aseptic processing. In this article, we discuss the PAT requirements for the GMP-compliant manufacturing of parenteral lipid emulsions, which can be used for clinical nutrition or for the delivery of lipophilic active ingredients. There are risks associated with the manufacturing processes, including the potential for unstable emulsions and the formation of large droplets that can induce embolisms in the patient. Parenteral emulsions are currently monitored offline using a statistical approach. Inline analytics, supplemented by measurements of zeta potential, could minimize the above risks. Laser scanning technology, ultrasound attenuation spectroscopy, and photo-optical sensors combined with image analysis may prove to be useful PAT methods. In the future, these technologies could lead to better process understanding and control, thus improving production efficiency.
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Jensch, Christoph, Larissa Knierim, Martin Tegtmeier, and Jochen Strube. "Development of a General PAT Strategy for Online Monitoring of Complex Mixtures—On the Example of Natural Product Extracts from Bearberry Leaf (Arctostaphylos uva-ursi)." Processes 9, no. 12 (November 25, 2021): 2129. http://dx.doi.org/10.3390/pr9122129.

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For the first time, a universally applicable and methodical approach from characterization to a PAT concept for complex mixtures is conducted—exemplified on natural products extraction processes. Bearberry leaf (Arctostaphylos uva-ursi) extract is chosen as an example of a typical complex mixture of natural plant origin and generalizable in its composition. Within the quality by design (QbD) based process development the development and implementation of a concept for process analytical technology (PAT), a key enabling technology, is the next necessary step in risk and quality-based process development and operation. To obtain and provide an overview of the broad field of PAT, the development process is shown on the example of a complex multi-component plant extract. This study researches the potential of different process analytical technologies for online monitoring of different component groups and classifies their possible applications within the framework of a QbD-based process. Offline and online analytics are established on the basis of two extraction runs. Based on this data set, PLS models are created for the spectral data, and correlations are conducted for univariate data. In a third run, the prediction potential is researched. Conclusively, the results of this study are arranged in the concept of a holistic quality and risk-based process design and operation concept.
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O'Shea, Norah, Tom F. O'Callaghan, and John T. Tobin. "The application of process analytical technologies (PAT) to the dairy industry for real time product characterization - process viscometry." Innovative Food Science & Emerging Technologies 55 (July 2019): 48–56. http://dx.doi.org/10.1016/j.ifset.2019.05.003.

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Singha Roy, Pritha, Gaurab Joarder, Saibal Debnath, and Avisek Pahari. "A REVIEW OF THE INNOVATIVE DRYING TECHNOLOGIES FOR BIOPHARMACEUTICALS." International Journal of Advanced Research 10, no. 05 (May 31, 2022): 1100–1111. http://dx.doi.org/10.21474/ijar01/14820.

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Reviewing data from the previous twenty to twenty-five years reveals that bio-pharmaceuticals are a sudden, dramatic, and incredibly significant finding in progressively enhancing the quality of life for patients with different kinds of malignancies, auto-immune illnesses, genetic disorders, etc. Drying technologies are a required manufacturing step in the pharmaceutical industry/production unit, and an understanding of drying technologies and how to use them is now an absolute must. With the increased demand for biopharmaceuticals, it is essential to reduce production costs without sacrificing product safety, quality, or effectiveness. The predominant commercial method for generating solid biopharmaceuticals is batch freeze-drying. However, freeze-drying is expensive compared to other procedures and is not ideal for lengthy working hours, in addition to requiring a large initial capital investment and significant energy consumption, resulting in high total expenses. This article discusses innovative drying methods for parenteral biopharmaceuticals. Spin-freeze drying, spray drying, and Lynfinity® Technology enable continuous manufacturing, while PRINT® Technology and MicroglassificationTM manage dry particle characteristics. As a consequence, certain drying processes may need less validation. Process Analytical Technology (PAT) and offline dramatisation may give extra information on CPPs and CQAs during biopharmaceutical manufacture. These processing approaches might boost biopharmaceutical product production while reducing expenses.
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Uhlenbrock, Lukas, Maximilian Sixt, Martin Tegtmeier, Hartwig Schulz, Hansjörg Hagels, Reinhard Ditz, and Jochen Strube. "Natural Products Extraction of the Future—Sustainable Manufacturing Solutions for Societal Needs." Processes 6, no. 10 (October 1, 2018): 177. http://dx.doi.org/10.3390/pr6100177.

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The production of plant-based extracts is significantly influenced by traditional techniques and the natural variability of feedstock. For that reason, the discussion of innovative approaches to improve the manufacturing of established products and the development of new products within the regulatory framework is essential to adapt to shifting quality standards. This perspective of members of the DECHEMA/ProcessNet working group on plant-based extracts outlines extraction business models and the regulatory framework regarding the extraction of traditional herbal medicines as complex extracts. Consequently, modern approaches to innovative process design methods like QbD (Quality by Design) and quality control in the form of PAT (Process Analytical Technology) are necessary. Further, the benefit of standardized laboratory equipment combined with physico-chemical predictive process modelling and innovative modular, flexible batch or continuous manufacturing technologies which are fully automated by advanced process control methods are described. A significant reduction of the cost of goods, i.e., by a factor of 4–10, and decreased investments of about 1–5 mil. € show the potential for new products which are in line with market requirements.
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Yokoyama, Reiji, Go Kimura, Christian Schlepütz, Jörg Huwyler, and Maxim Puchkov. "Modeling of Disintegration and Dissolution Behavior of Mefenamic Acid Formulation Using Numeric Solution of Noyes-Whitney Equation with Cellular Automata on Microtomographic and Algorithmically Generated Surfaces." Pharmaceutics 10, no. 4 (December 3, 2018): 259. http://dx.doi.org/10.3390/pharmaceutics10040259.

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Manufacturing parameters may have a strong impact on the dissolution and disintegration of solid dosage forms. In line with process analytical technology (PAT) and quality by design approaches, computer-based technologies can be used to design, control, and improve the quality of pharmaceutical compacts and their performance. In view of shortcomings of computationally intensive finite-element or discrete-element methods, we propose a modeling and simulation approach based on numerical solutions of the Noyes-Whitney equation in combination with a cellular automata-supported disintegration model. The results from in vitro release studies of mefenamic acid formulations were compared to calculated release patterns. In silico simulations with our disintegration model showed a high similarity of release profile as compared to the experimental evaluation. Furthermore, algorithmically created virtual tablet structures were in good agreement with microtomography experiments. We conclude that the proposed computational model is a valuable tool to predict the influence of material attributes and process parameters on drug release from tablets.
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Schmidt, Axel, Heribert Helgers, Florian Lukas Vetter, Alex Juckers, and Jochen Strube. "Fast and Flexible mRNA Vaccine Manufacturing as a Solution to Pandemic Situations by Adopting Chemical Engineering Good Practice—Continuous Autonomous Operation in Stainless Steel Equipment Concepts." Processes 9, no. 11 (October 21, 2021): 1874. http://dx.doi.org/10.3390/pr9111874.

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SARS-COVID-19 vaccine supply for the total worldwide population has a bottleneck in manufacturing capacity. Assessment of existing messenger ribonucleic acid (mRNA) vaccine processing shows a need for digital twins enabled by process analytical technology approaches in order to improve process transfer for manufacturing capacity multiplication, a reduction in out-of-specification batch failures, qualified personal training for faster validation and efficient operation, optimal utilization of scarce buffers and chemicals and speed-up of product release by continuous manufacturing. In this work, three manufacturing concepts for mRNA-based vaccines are evaluated: Batch, full-continuous and semi-continuous. Technical transfer from batch single-use to semi-continuous stainless-steel, i.e., plasmid deoxyribonucleic acid (pDNA) in batch and mRNA in continuous operation mode, is recommended, in order to gain: faster plant commissioning and start-up times of about 8–12 months and a rise in dose number by a factor of about 30 per year, with almost identical efforts in capital expenditures (CAPEX) and personnel resources, which are the dominant bottlenecks at the moment, at about 25% lower operating expenses (OPEX). Consumables are also reduceable by a factor of 6 as outcome of this study. Further optimization potential is seen at consequent digital twin and PAT (Process Analytical Technology) concept integration as key-enabling technologies towards autonomous operation including real-time release-testing.
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Metze, S., S. Ruhl, G. Greller, C. Grimm, and J. Scholz. "Monitoring online biomass with a capacitance sensor during scale-up of industrially relevant CHO cell culture fed-batch processes in single-use bioreactors." Bioprocess and Biosystems Engineering 43, no. 2 (September 23, 2019): 193–205. http://dx.doi.org/10.1007/s00449-019-02216-4.

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Abstract In 2004, the FDA published a guideline to implement process analytical technologies (PAT) in biopharmaceutical processes for process monitoring to gain process understanding and for the control of important process parameters. Viable cell concentration (VCC) is one of the most important key performance indicator (KPI) during mammalian cell cultivation processes. Commonly, this is measured offline. In this work, we demonstrated the comparability and scalability of linear regression models derived from online capacitance measurements. The linear regressions were used to predict the VCC and other familiar offline biomass indicators, like the viable cell volume (VCV) and the wet cell weight (WCW), in two different industrially relevant CHO cell culture processes (Process A and Process B). Therefore, different single-use bioreactor scales (50–2000 L) were used to prove feasibility and scalability of the in-line sensor integration. Coefficient of determinations of 0.79 for Process A and 0.99 for Process B for the WCW were achieved. The VCV was described with high coefficients of determination of 0.96 (Process A) and 0.98 (Process B), respectively. In agreement with other work from the literature, the VCC was only described within the exponential growth phase, but resulting in excellent coefficients of determination of 0.99 (Process A) and 0.96 (Process B), respectively. Monitoring these KPIs online using linear regression models appeared to be scale-independent, enabled deeper process understanding (e.g. here demonstrated in monitoring, the feeding profile) and showed the potential of this method for process control.
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Dissertations / Theses on the topic "Process analytical technologies (PAT)"

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Schneid, Stefan Christian. "Investigation of novel process analytical technology (PAT) tools for use in freeze-drying processes." kostenfrei, 2009. http://d-nb.info/999755315/34.

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Metze, Sabrina [Verfasser]. "Scalability of single-use biopharmaceutical manufacturing processes using process analytical technology (PAT) tools / Sabrina Metze." Hannover : Gottfried Wilhelm Leibniz Universität Hannover, 2020. http://d-nb.info/1204459495/34.

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Dai, Bin. "SIMULATIONS-GUIDED DESIGN OF PROCESS ANALYTICAL SENSOR USING MOLECULAR FACTOR COMPUTING." UKnowledge, 2007. http://uknowledge.uky.edu/gradschool_diss/483.

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Many areas of science now generate huge volumes of data that present visualization, modeling, and interpretation challenges. Methods for effectively representing the original data in a reduced coordinate space are therefore receiving much attention. The purpose of this research is to test the hypothesis that molecular computing of vectors for transformation matrices enables spectra to be represented in any arbitrary coordinate system. New coordinate systems are selected to reduce the dimensionality of the spectral hyperspace and simplify the mechanical/electrical/computational construction of a spectrometer. A novel integrated sensing and processing system, termed Molecular Factor Computing (MFC) based near infrared (NIR) spectrometer, is proposed in this dissertation. In an MFC -based NIR spectrometer, spectral features are encoded by the transmission spectrum of MFC filters which effectively compute the calibration function or the discriminant functions by weighing the signals received from a broad wavelength band. Compared with the conventional spectrometers, the novel NIR analyzer proposed in this work is orders of magnitude faster and more rugged than traditional spectroscopy instruments without sacrificing the accuracy that makes it an ideal analytical tool for process analysis. Two different MFC filter-generating algorithms are developed and tested for searching a near-infrared spectral library to select molecular filters for MFC-based spectroscopy. One using genetic algorithms coupled with predictive modeling methods to select MFC filters from a spectral library for quantitative prediction is firstly described. The second filter-generating algorithm designed to select MFC filters for qualitative classification purpose is then presented. The concept of molecular factor computing (MFC)-based predictive spectroscopy is demonstrated with quantitative analysis of ethanol-in-water mixtures in a MFC-based prototype instrument.
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Powell, Keddon A. "Improving continuous crystallisation using process analytical technologies : design of a novel periodic flow process." Thesis, Loughborough University, 2017. https://dspace.lboro.ac.uk/2134/23982.

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In this thesis novel configurations and operating strategies in the mixed suspension mixed product removal (MSMPR) crystalliser are investigated, aided by integrated process analytical technologies (PAT) and crystallisation informatics system (CryPRINS) tools. The MSMPR is an idealised crystalliser model that assumes: steady-state operation; well mixed suspension with no product classification, such that all volume elements contain a mixture of particles (small and large) and crystal size distribution (CSD) that is independent of location in the crystalliser and is identical of the product withdrawn; and uniform supersaturation thought, leading to constant nucleation and growth rates. Single-stage MSMPR designs with continuous recycle/recirculation and modified heat exchanger were investigated and found to minimise fouling, encrustation and transfer line blockages. In particular, a modified MSMPR with baffled heat exchanger was found to significantly reduce the temperature between incoming feed hot feed solution and the cooled crystalliser, leading to a significant reduction in fouling, encrustation and blockages. In addition, the concept of the periodic mixed suspension mixed product removal (PMSMPR) crystallisation process is demonstrated for the first time viz single- and multi-stage cascaded operations. This method of operation involves the periodic transfer of slurry (addition and withdrawal) at high flow rates from either a single stirred vessel or between a number of stirred vessels arranged in series. The PMSMPR is therefore characterised by periodic withdrawals of product slurry. Similar to the MSMPR, the product withdrawn from a PMSMPR has exactly the same composition as the vessel at the time of removal. The rapid withdrawal of slurry at high flow rates in PMSMPR operation leads to the prevention of particle sedimentation and blockage of transfer lines. The transfer of slurry (to/from) the PMSMPR is followed by a holding (or pause) period when no addition or withdrawal of slurry takes place. The holding period extends the mean residence time of the PMSMPR relative to a typical MSMPR, thereby increasing the yield and productivity of crystallisation as more time is allowed for consumption of available supersaturation viz crystal growth and nucleation. A state of controlled operation (SCO) in the periodic flow process, defined as a state of the system that maintains itself despite regular, but controlled disruptions was characterised using the PAT tools and CryPRINS within an intelligent decision support (IDS) framework. The crystallisation of paracetamol (PCM) from isopropyl alcohol (IPA) using different configurations of a single-stage continuous MSMPR crystalliser that incorporated continuous recycle and recirculation loop, and a novel design with baffled heat exchanger was investigated. Crystallisations of PCM-IPA carried out in the MSMPR without heat exchanger suffered from severe fouling, encrustation and blockage problems due to the high level of supersaturation (S = 1.39) in the crystalliser, which was required for the initial burst of nucleation to generate enough particles for later growth, as well as the large temperature difference between the incoming feed (45 oC) and the crystalliser (10 oC). Using the modified MSMPR design with baffled heat exchanger, the challenges of fouling, encrustation and blockage were significantly reduced due to the rapid lowering of the feed stream temperature prior to entering the crystalliser. In addition, the closed loop system led to conservation of material, which is a great benefit since large amounts of materials would otherwise be required if the MSMPR was operated with continuous product removal. This design is great for research purposes, in particular, to investigate process design and optimisation. Continuous crystallisation of PCM in the presence of hydroxyl propyl methyl cellulose (HPMC) additive was investigated in the modified MSMPR design with heat exchanger. HPMC was found to improve the crystallisation performance, leading to complete avoidance of fouling, encrustation and blockages at a concentration of 0.05 wt%. However, the yield of crystallisation was significantly reduced (28.0 %) compared to a control experiment (98.8 %, biased due to fouling/encrustation) performed without additive addition. Regardless, the productivity of crystallisation was more than four times that achieved in batch linear cooling (LC) (0.62 0.86 g/L-min) and batch automated dynamic nucleation control (ADNC) (0.24 0.25 g/L-min) runs. Aspects of the periodic flow crystallisation of single- and multi-component (co-crystals) molecular systems have also been examined to demonstrate the concept of state of controlled operation . The single component systems studied were PCM and glycine (GLY), each representative of compounds with slow and fast growth kinetics, respectively. The co-crystal systems investigated were urea-barbituric acid (UBA) and p Toluenesulfonamide-Triphenylphosphine oxide (p-TSA-TPPO). UBA is a polymorphic co-crystal system with three known forms (I, II and III). Form I UBA was successfully isolated in a three-stage periodic flow PMSMPR crystalliser. This study demonstrates the capability of periodic flow crystallisation for isolation of a desired polymorph from a mixture. p-TSA-TPPO exists in two known stoichiometric co-crystal forms, 1:1 and 3:2 mole ratio p-TSA-TPPO, respectively. The two crystalline forms exhibit solution mediated transformation, which proves to be a difficulty for separation. For this study, the implementation of temperature cycles in batch and flow control in semi-batch and periodic PMSMPR crystallisers were investigated to isolate pure 1:1 and 3:2 p-TSA-TPPO, respectively. Different regions of the ternary diagram of p-TSA, TPPO and acetonitrile (MeCN) were investigated. The desired co-crystal form was isolated all crystallisation platforms investigated. However, greater consistency was observed in the semi-batch and PMSMPR operations respectively. Periodic flow crystallisation in PMSMPR is a promising alternative to conventional continuous MSMPR operation, affording greater degrees of freedom operation, slightly narrower RTD profiles, consistent product crystal quality (size, shape and distribution), longer mean residence times, higher yield and productivity and significant reduction in fouling, encrustation and transfer line blockages over prolonged operating periods. Furthermore, the PMSMPR is a versatile platform that can be used to investigate a range of different molecular systems. Relative to batch operation, the PMSMPR can operate close to equilibrium, however, this is dependent on the system kinetics. In addition, retrofitting of batch crystallisers to operate as PMSMPRS fairly simple and require only subtle changes to the existing design space. The integrated array of PAT sensors consisted of attenuated total reflectance ultra violet/visible spectroscopy (ATR-UV/vis), attenuated total reflectance Fourier transform infrared spectroscopy (ATR-FTIR), focused beam reflectance measurement (FBRM), particle vision microscopy (PVM) and Raman spectroscopy. The results from the studies reported here illustrate very well the use of PAT and information system tools together to determine when the continuous and periodic MSMPR operations reaches a steady-state or state of controlled operation (i.e. periodic steady-state). These tools provided a better understanding of the variables and operating procedures that influence the two types of operations.
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Simone, Elena. "Application of process analytical technology (PAT) tools for the better understanding and control of the crystallization of polymorphic and impure systems." Thesis, Loughborough University, 2015. https://dspace.lboro.ac.uk/2134/20098.

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This work presents a comprehensive study on the application of PAT tools to study, monitor and control polymorphism during batch cooling crystallization processes. For the first time, the same techniques were used to control and adjust polymorphic purity of the solid phase but also to investigate the relation between chemical equilibrium in solution and polymorphic outcome of cooling crystallization. Crystallization is an important unit operation used as separation and purification technique. It is widely employed in the pharmaceutical, chemical, agrochemical, food and cosmetics industries but also in the electronic, metallurgic and material industries. More than 90% of the APIs on the market are produced by crystallization, therefore, monitoring and control this process is fundamental to ensure the quality of the final product. The implementation of process analytical technology (PAT) tools during the development stage of APIs has largely helped in better understanding and optimizing both batch and, more recently, continuous crystallization. Polymorphism is the capacity of a compound to crystallize in more than one different crystalline structure, which can have different properties such as density, melting point, bioavailability and solubility. The choice of solvent, pH, kinetic conditions and presence of impurities has very strong effect on the polymorphic outcome of a cooling crystallization in solution. Understanding this phenomenon as well as being able to monitor and control it during industrial crystallization is one the biggest challenges for pharmaceutical industries.
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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 actif pharmaceutique. Au cours du procédé les teneurs en principe actif et en solvant résiduel doivent être déterminées avec précision afin d'atteindre un point d'ensemencement prédéfini. Une méthodologie basée sur les principes du QbD a guidé le développement et la validation de la méthode tout en assurant l'adéquation avec son utilisation prévue. Des modèles basés sur les moindres carrés partiels ont été construits à l'aide d'outils chimiométriques afin de quantifier les 2 analytes d'intérêt. La méthode a été totalement validée conformément aux requis officiels en utilisant les profils d'exactitude. Un suivi du procédé en temps réel a permis de prouver que la méthode correspond à son usage prévu.L'implémentation de cette méthode comme à l'échelle industrielle au lancement de ce nouveau procédé permettra le contrôle automatique de l'étape de cristallisation dans le but d'assurer un niveau de qualité prédéfini de l'API. D'autres avantages sont attendus incluant la réduction du temps du procédé, la suppression d'un échantillonnage difficile et d'analyses hors ligne fastidieuses
Pharmaceutical companies are progressively adopting and introducing the Process Analytical Technology (PAT) concept to control and ensure in real-time product quality in development and manufacturing. PAT is a key component of the Quality-by-Design (QbD) framework promoted by the regulatory authorities, aiming the building of product quality based on both a strong scientific background and a quality risk management approach.An analytical method based on near infrared (NIR) spectroscopy was developed as a PAT tool to control on-line an API (active pharmaceutical ingredient) crystallization. During this process the API and residual solvent contents need to be precisely determined to reach a predefined seeding point. An original methodology based on the QbD principles was applied to conduct the development and validation of the NIR method and to ensure that it is fitted for its intended use. Partial least squares (PLS) models were developed and optimized through chemometrics tools in order to quantify the 2 analytes of interest. The method was fully validated according to the official requirements using the accuracy profile approach. Besides, a real-time process monitoring was added to the validation phase to prove and document that the method is fitted for purpose.Implementation of this method as an in-process control at industrial plant from the launch of this new pharmaceutical process will enable automatic control of the crystallization step in order to ensure a predefined quality level of the API. Other valuable benefits are expected such as reduction of the process time, and suppression of a difficult sampling and tedious off-line analyzes
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Brestrich, Nina [Verfasser], and J. [Akademischer Betreuer] Hubbuch. "Development of process analytical technologies for chromatography based protein purification / Nina Brestrich. Betreuer: J. Hubbuch." Karlsruhe : KIT-Bibliothek, 2016. http://d-nb.info/1108450806/34.

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Helmdach, Lydia Verfasser], Joachim [Akademischer Betreuer] Ulrich, Martin [Akademischer Betreuer] Feth, and Ulrich [Akademischer Betreuer] [Teipel. "Application of process analytical technology (PAT) tools to develop and monitor scalable crystallization processes of pharmaceuticals / Lydia Helmdach. Betreuer: Joachim Ulrich ; Martin Feth ; Ulrich Teipel." Halle, Saale : Universitäts- und Landesbibliothek Sachsen-Anhalt, 2013. http://d-nb.info/1046563432/34.

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Bellamy, Luke J. "Application of non-invasive process analytical technologies to characterise the factors influencing mixing and measurement of powders." Thesis, University of Strathclyde, 2006. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.426355.

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Warth, Benedikt. "Design and Application of Software Sensors in Batch and Fed-batch Cultivations during Recombinant Protein Expression in Escherichia coli." Thesis, Linköping University, The Department of Physics, Chemistry and Biology, 2008. http://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-12530.

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Software sensors are a potent tool to improve biotechnological real time process monitoring and control. In the current project, algorithms for six partly novel, software sensors were established and tested in a microbial reactor system. Eight batch and two fed-batch runs were carried out with a recombinant Escherichia coli to investigate the suitability of the different software sensor models in diverse cultivation stages. Special respect was given to effects on the sensors after recombinant protein expression was initiated by addition of an inducer molecule. It was an objective to figure out influences of excessive recombinant protein expression on the software sensor signals.

Two of the developed algorithms calculated the biomass on-line and estimated furthermore, the specific growth rate by integration of the biomass changes with the time. The principle of the first was the application of a near infrared probe to obtain on-line readings of the optical density. The other algorithm was founded on the titration of ammonia as only available nitrogen source. The other two sensors analyzed for the specific consumption of glucose and the specific production of acetate and are predicted on an in-line HPLC system.

The results showed that all software sensors worked as expected and are rather powerful to estimate important state parameters in real time. In some stages, restrictions may occur due to different limitation affects in the models or the physiology of the culture. However, the results were very convincing and suggested the development of further and more advanced software sensor models in the future.

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Books on the topic "Process analytical technologies (PAT)"

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Bavsun, Irina, Oleg Beketov, and Oleg Dizer. Fundamentals of management in the internal affairs bodies. ru: INFRA-M Academic Publishing LLC., 2022. http://dx.doi.org/10.12737/1845926.

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The textbook discusses the main aspects of management in the internal affairs bodies: the organization of the management system in the internal affairs bodies of the Russian Federation; the process and technologies of law enforcement management; functions, forms and methods of management; organization of work with personnel in the internal affairs bodies and socio-psychological aspects of management; information and analytical work and management decisions, as well as a number of provisions of the scientific organization of labor in the internal affairs bodies. Meets the requirements of the federal state educational standards of secondary vocational education of the latest generation. For students of secondary vocational education programs, which include the discipline "Fundamentals of management in internal affairs bodies", as well as for teachers.
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Serebryakov, Andrey, Tat'yana Smirnova, Valentina Mercheva, and Elena Soboleva. Chemistry of combustible minerals. ru: INFRA-M Academic Publishing LLC., 2021. http://dx.doi.org/10.12737/1041945.

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This textbook is a publication of the latest generation, designed to optimize the national project "Education"; develops theoretical knowledge about the genesis of natural liquid, gaseous and solid combustible minerals, the formation of the composition and properties, the practical significance of fuel and energy natural complexes. It is devoted to the study of the composition, properties and classification of oils, gas condensate, natural gases and solid combustible minerals, studied at the level of modern achievements of instrumental analytical and factory equipment in accordance with existing technologies, theories and hypotheses about the genesis of hydrocarbons and Earth sciences. The publication is supplemented with the main directions of processing of combustible minerals. Digital and graphical types of chemical models of the synergy of components of gas and oil deposits are described, which are necessary for predicting the phase state and composition of hydrocarbons and optimizing the directions of processing of marketable products. To facilitate the process of cognition of the origin and formation of the composition and properties of natural combustible minerals, a glossary, tests, as well as questions for the test and exam are offered. To control the knowledge gained by students while studying textbook materials, each chapter is accompanied by questions and tasks. Meets the requirements of the federal state educational standards of higher education of the latest generation. It is intended for students studying in the fields of 05.04.01, 05.03.01 "Geology", 21.05.02 "Applied Geology", as well as for specialists in the field of geology, geochemistry, extraction and processing of oil, gas, gas condensate, solid fuels.
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PAT instrumentation: The pharmaceutical and biotechnology market for process analytical technology. Los Angeles: Strategic Directions International, Inc., 2006.

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Dussubieux, Laure, and Heather Walder, eds. The Elemental Analysis of Glass Beads. Leuven University Press, 2022. http://dx.doi.org/10.11116/9789461664655.

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Glass beads, both beautiful and portable, have been produced and traded globally for thousands of years. Modern archaeologists study these artifacts through sophisticated methods that analyze the glass composition, a process which can be utilized to trace bead usage through time and across regions. This book publishes open-access compositional data obtained from laser ablation – inductively coupled plasma – mass spectrometry, from a single analytical laboratory, providing a uniquely comparative data set. The geographic range includes studies of beads produced in Europe and traded widely across North America and beads from South and Southeast Asia traded around the Indian Ocean and beyond. The contributors provide new insight on the timing of interregional interactions, technologies of bead production and patterns of trade and exchange, using glass beads as a window to the past. This volume will be a key reference for glass researchers, archaeologists, and any scholars interested in material culture and exchange; it provides a wide range of case studies in the investigation and interpretation of glass bead composition, production and exchange since ancient times.
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El Namaki, MSS, and Pooja Sharma, eds. Management of Data in AI Age. CSMFL Publications, 2020. http://dx.doi.org/10.46679/isbn9788194848349.

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This book is a compilation of contributed works on management of data in the age of artificial intelligence. The AI technologies have changed the way the businesses do manage themselves in modern times. It becomes much more important to manage the data a business owns when the same can be collated and used by the allied AI technologies for forming business decisions. This book highlights how AI and machine learning can help businesses categorise and manage their organizational data. The book introduces how small businesses can benefit from AI technologies for their data management with limited budgets. The book advocates for making AI processes to be core part of consumer experience and support management within the businesses. As a unique feature, this book also goes to make an awareness as to how human brain can use AI’s deep learning capabilities to make reflective decisions. The book also introduces as to how big data and big data analytics can help agriculture and farm management sector. It is hoped that the readership will find this book useful in the areas of big data management, machine learning and data decisions, AI technologies for small businesses, usage of AI in emerging sectors and those areas where data needs to managed in an environment of automation.
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Arkhipova, M. Yu, M. V. Kagirova, A. V. Ukolova, Yu N. Romantseva, A. E. Kharitonova, and V. V. Demichev. Analysis of the international practice of digitalization implementation in the agro-industrial complex of national and supranational economies, on the example of countries with traditionally developed agriculture. Publishing house of the Russian state agrarian University UN-TA im. K. A. Timiryazeva, 2021. http://dx.doi.org/10.26897/978-5-907477-35-3-2021-118.

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The analytical materials contain the results of studying the main trends in the development of agriculture, including the features of the use of digital technologies in the agricultural sector of countries with different levels of agricultural development and the degree of digitalization of the economy, a developed system of statistical indicators for a comprehensive description of the conditions, the process of results and the effectiveness of the use of digital technologies in agriculture, a system of indicators for monitoring these processes.
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Pisarenko, T. V., T. K. Kvasha, T. V. Havrys, O. F. Paladchenko, I. V. Molchanova, N. I. Shabranska, A. B. Osadcha, and O. P. Kochetkova. Analysis of world technological trends in the military sphere. State Institution “Ukrainian Institute of Scientific and Technical Expertise and Information”, 2021. http://dx.doi.org/10.35668/978-966-479-127-1.

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Today, the scientific and technological sphere has become the main arena of competition between countries in the world, and the use of new technologies, especially in the field of armaments, is considered as one of the most important levers of geopolitics. Such technologies are a key for expanding the capabilities of the state's defense capabilities and achieving national security goals, priory to military and military-economic, as well as scientific and technological security. Today, the identification of scientific and technological key areas of military development is used to determine the priorities of scientific and technological development and military-technical policy which is crucial for the process of creating promising models of armaments and military equipment. The introduction of the latest technologies in the military is difficult to imagine without the use of computer and other telecommunications equipment, artificial intelligence technology, military robotics, quantum and space technology, 3D printing and biotechnology. Although they all are already used in the military and security spheres, still monitoring innovation and new technologies in the military are important for understanding not only future wars, but also global security. This study reviews global technological trends based on the analysis of publications of foreign consulting agencies, international organizations and forecasting and analytical research conducted by the author's methodology. The data upon perspective directions of development of scientific and technological researches in the military sphere on the basis of the analysis of publishing activity of a DB of Web of Science and a DB of patents of Derwent Innovations is provided. In particular, the range of new directions of technological development of the military sphere has been expanded and clarified not only in general, but also specified by types and kinds of troops. This analysis allowed us to determine that the areas of development claimed by international organizations and consulting agencies correlate with the areas identified by the authors of the study on the basis of scientometric and patent analysis. At the same time, the forecasted promising areas of research, determined by scientometric analysis of Web of Science publications, more or less completely coincide with the forecasts of NATO, RAND Corporation.
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Book chapters on the topic "Process analytical technologies (PAT)"

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Esbensen, Kim H., and Peter Paasch-Mortensen. "Process Sampling: Theory of Sampling - the Missing Link in Process Analytical Technologies (PAT)." In Process Analytical Technology, 37–80. Chichester, UK: John Wiley & Sons, Ltd, 2010. http://dx.doi.org/10.1002/9780470689592.ch3.

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Lundsberg-Nielsen, Line, Walkiria S. Schlindwein, and Andreas Berghaus. "Process Analytical Technology (PAT)." In Pharmaceutical Quality by Design, 227–55. Chichester, UK: John Wiley & Sons, Ltd, 2018. http://dx.doi.org/10.1002/9781118895238.ch9.

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Hussain, Ajaz S. "Process Analytical Technology (PAT)." In Handbook of Validation in Pharmaceutical Processes, 883–915. 4th ed. Boca Raton: CRC Press, 2021. http://dx.doi.org/10.1201/9781003163138-56.

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Dickens, Jason E. "Overview of Process Analysis and PAT." In Process Analytical Technology, 1–15. Chichester, UK: John Wiley & Sons, Ltd, 2010. http://dx.doi.org/10.1002/9780470689592.ch1.

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Miller, Charles E. "Chemometrics in Process Analytical Technology (PAT)." In Process Analytical Technology, 353–438. Chichester, UK: John Wiley & Sons, Ltd, 2010. http://dx.doi.org/10.1002/9780470689592.ch12.

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Smith-Goettler, Brandye. "On-Line PAT Applications of Spectroscopy in the Pharmaceutical Industry." In Process Analytical Technology, 439–61. Chichester, UK: John Wiley & Sons, Ltd, 2010. http://dx.doi.org/10.1002/9780470689592.ch13.

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Romía, Marcelo Blanco, and Manel Alcalá Bernárdez. "NIR spectroscopy in Pharmaceutical Analysis: Off-line and At-line PAT Applications." In Process Analytical Technology, 463–91. Chichester, UK: John Wiley & Sons, Ltd, 2010. http://dx.doi.org/10.1002/9780470689592.ch14.

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Bakeev, Katherine A., and Jose C. Menezes. "Future Trends for PAT for Increased Process Understanding and Growing Applications in Biomanufacturing." In Process Analytical Technology, 521–43. Chichester, UK: John Wiley & Sons, Ltd, 2010. http://dx.doi.org/10.1002/9780470689592.ch16.

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Möhring, Michael, Barbara Keller, Rainer Schmidt, Matthias Gutmann, and Scott Dacko. "HOTFRED: A Flexible Hotel Fake Review Detection System." In Information and Communication Technologies in Tourism 2021, 308–14. Cham: Springer International Publishing, 2021. http://dx.doi.org/10.1007/978-3-030-65785-7_29.

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AbstractThe importance to cope with online fake reviews in Tourism becomes more and more evident. In the hotel sector hoteliers as well as guests often struggle with the challenges to separate true and fake reviews from each other. Therefore, our research introduces HOTFRED - a flexible hotel fake review detection system - as part of an on-going research project. By combining different analytical approaches, the HOTFRED system indicates via an aggregated probability whether a review is true or fake. As the evaluation of the prototypical implementation showed, this approach can support to detect fake reviews. Many different stakeholders in the Tourism sector can profit from this automatic tool. Thus, hoteliers can take measures to safe their reputation, guests can benefit in their decision-making process and research might use the tool as an initial starting point for future research in the area of fake information.
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Brearley, Ann M., and Susan J. Foulk. "Near-Infrared Spectroscopy (NIR) as a PAT Tool in the Chemical Industry: Added Value and Implementation Challenges." In Process Analytical Technology, 493–520. Chichester, UK: John Wiley & Sons, Ltd, 2010. http://dx.doi.org/10.1002/9780470689592.ch15.

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Conference papers on the topic "Process analytical technologies (PAT)"

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Murphy, Trevor, Niall O'Mahony, Krishna Panduru, Daniel Riordan, and Joseph Walsh. "Pharmaceutical manufacturing and the quality by design (QBD), process analytical technology (PAT) approach." In 2016 27th Irish Signals and Systems Conference (ISSC). IEEE, 2016. http://dx.doi.org/10.1109/issc.2016.7528465.

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Choobineh, Leila, Dereje Agonafer, and Ankur Jain. "Analytical Modeling of Temperature Distribution in Interposer-Based Microelectronic Systems." In ASME 2013 International Technical Conference and Exhibition on Packaging and Integration of Electronic and Photonic Microsystems. American Society of Mechanical Engineers, 2013. http://dx.doi.org/10.1115/ipack2013-73166.

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Heterogeneous integration in microelectronic systems using interposer technology has attracted significant research attention in the past few years. Interposer technology is based on stacking of several heterogeneous chips on a common carrier substrate, also referred to as the interposer. Compared to other technologies such as System-on-Chip (SoC) or System-in-Package (SiP), interposer-based integration offers several technological advantages. However, the thermal management of an interposer-based system is not well understood. The presence of multiple heat sources in various die and the interposer itself needs to be accounted for in any effective thermal model. While a finite-element based simulation may provide a reasonable temperature prediction tool, an analytical solution is highly desirable for understanding the fundamentals of the heat transfer process in interposers. In this paper, we describe our recent work on analytical modeling of heat transfer in interposer-based microelectronic systems. The basic governing energy conservation equations are solved to derive analytical expressions for the temperature distribution in an interposer-based microelectronic system. These solutions are combined with an iterative approach to provide the three-dimensional temperature field in an interposer. Results are in excellent agreement with finite-element solutions. The analytical model is utilized to study the effect of various parameters on the temperature field in an interposer system. Results from this work may be helpful in the thermal design of microelectronic systems containing interposers.
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Social Listening, How, Big Data, and AI Apply in the Business Decision Process. "Machine Learningin FMCG." In Human Interaction and Emerging Technologies (IHIET-AI 2022) Artificial Intelligence and Future Applications. AHFE International, 2022. http://dx.doi.org/10.54941/ahfe100920.

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Without a machine, human beings cannot process the massive data volume produced by us nowadays for business analysis purposes. Being part of the critical decision-making process in the commercial sector, the usage and role of Big Data, especially those collected from social listening are getting important: how a company listen to the true voices from a group of genuine customers and avoid those misleading, fake comments generated by the robot, to enhance the efficiency on measuring competitor's performance towards their marketing return compared to the investment (MROI), is critical and more challenging.In this paper, we will discuss various analytical methodologies from the angles of business and technological viewpoint: what decision-makers want from social media, what kind of information are they looking into, how visualization provides instant insights and what kind of system design provides enough interaction to the decision-maker. We will investigate the real-world challenges and difficulties: how the data inconsistency affects the computational analysis, what kind of obstacles was facing in the existing product de-sign in the market. Finally, we will conclude the used machine learning techniques that can address the mentioned business problems, including the successful rate, accuracy and various efficiency level in the studied samples.
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Neri, Simona, Elodie Bugnicourt, and Ignacio Montero. "Process Analytical Technologies for Industrial Nanoparticles Production." In 14th Mediterranean Congress of Chemical Engineering (MeCCE14). Grupo Pacífico, 2020. http://dx.doi.org/10.48158/mecce-14.dg.02.03.

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Colucci, Domenico, José Manuel Prats-Montalban, Davide Fissore, and Alberto Ferrer Riquelme. "Application of Multivariate Image Analysis to Thermal Images for in line Monitoring of the Freeze-Drying Process." In 21st International Drying Symposium. Valencia: Universitat Politècnica València, 2018. http://dx.doi.org/10.4995/ids2018.2018.7558.

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A new Process Analytical Technology (PAT) has been developed and tested for on-line process monitoring of a vacuum freeze-drying process. The sensor uses an infrared camera to obtain thermal images of the ongoing process and multivariate image analysis (MIA) to extract the information after automatic detection and segmentation of the region corresponding to the product in every vial. A reference model was built, using the information of six batches, and different kind of anomalous events, involving either single vials in the batch or the whole batch, were simulated to test the capacity of the MIA-based monitoring system to promptly identify them. Keywords: freeze-drying; process monitoring; infrared image; multivariate image analysis.
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Ancona, M. A., M. Bianchi, F. Melino, and A. Peretto. "Power Augmentation Technologies: Part II — Thermo-Economic Analysis." In ASME Turbo Expo 2015: Turbine Technical Conference and Exposition. American Society of Mechanical Engineers, 2015. http://dx.doi.org/10.1115/gt2015-43178.

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There exists a widespread interest in the application of gas turbine Power Augmentation Technologies (PATs) in both electric power generation and mechanical drive markets. This interest is attributable to liberalization in the power generation sector, increased electric rates during peak demand period and need for a proper selection of the gas turbine in a given application. In the Part II of this study, an analytical evaluation of the ambient temperature effect on gas turbines performance is presented. Further, the achievable power boost due to the installation of the most adopted PAT strategies is deeply investigated. Considering a whole year of operation for a large number of worldwide locations, also the behavior change — due to the use of the PATs — on both the energy production and the economic aspect will be analyzed and discussed.
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Kaur, Jasleen, Alka Agrawal, and Raees Ahmad Khan. "Security Assessment in Foggy Era through Analytical Hierarchy Process." In 2020 11th International Conference on Computing, Communication and Networking Technologies (ICCCNT). IEEE, 2020. http://dx.doi.org/10.1109/icccnt49239.2020.9225308.

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Häring, I., J. Scheidereiter, S. Ebenhöch, D. Schott, L. Reindl, S. Köhler, J. Bordoy, C. Schindelhauer, H. Scheithauer, and S. Kaufmann. "Analytical engineering process to identify, assess and improve technical resilience capabilities." In The 2nd International Conference on Engineering Sciences and Technologies. CRC Press Taylor & Francis Group 6000 Broken Sound Parkway NW, Suite 300 Boca Raton, FL 33487-2742: CRC Press, 2017. http://dx.doi.org/10.1201/9781315210469-136.

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Azhar, Ahsan, Muhammad Amin, Mohammad Nauman, and Shakir Ullah Shah. "Efficient selection of access control systems through multi criteria analytical hierarchy process." In 2012 International Conference on Emerging Technologies (ICET). IEEE, 2012. http://dx.doi.org/10.1109/icet.2012.6375419.

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Li, Ya, and Chuanzhi Li. "Analytical hierarchy process model applied to port logistics efficiency commentary." In 2010 International Conference on E-Health Networking, Digital Ecosystems and Technologies (EDT). IEEE, 2010. http://dx.doi.org/10.1109/edt.2010.5496529.

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Reports on the topic "Process analytical technologies (PAT)"

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Mazorchuk, Mariia S., Tetyana S. Vakulenko, Anna O. Bychko, Olena H. Kuzminska, and Oleksandr V. Prokhorov. Cloud technologies and learning analytics: web application for PISA results analysis and visualization. [б. в.], June 2021. http://dx.doi.org/10.31812/123456789/4451.

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This article analyzes the ways to apply Learning Analytics, Cloud Technologies, and Big Data in the field of education on the international level. This paper provides examples of international analytical researches and cloud technologies used to process the results of those researches. It considers the PISA research methodology and related tools, including the IDB Analyzer application, free R intsvy environment for processing statistical data, and cloud-based web application PISA Data Explorer. The paper justifies the necessity of creating a stand-alone web application that supports Ukrainian localization and provides Ukrainian researchers with rapid access to well-structured PISA data. In particular, such an application should provide for data across the factorial features and indicators applied at the country level and demonstrate the Ukrainian indicators compared to the other countries’ results. This paper includes a description of the application core functionalities, architecture, and technologies used for development. The proposed solution leverages the shiny package available with R environment that allows implementing both the UI and server sides of the application. The technical implementation is a proven solution that allows for simplifying the access to PISA data for Ukrainian researchers and helping them utilize the calculation results on the key features without having to apply tools for processing statistical data.
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Merkulova, Yuliya. Система цифровых моделей - новая технология для баланса данных. Yuliya Merkulova, April 2021. http://dx.doi.org/10.12731/er0430.26042021.

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Use of the digital technologies is new and very productive approach for balance of different data. It is very important for balance of supply and demand and for increase of competitiveness of products. Various types of digital models were developed as a result of scientific research, they found reflection in article. Digital models for the description of the list of the sequences of steps and operations of various stages and process in general allow to install system of interrelations between operations and steps and to reach necessary log-ic, increase of effectiveness of any process. Object-relational models for establishment of communications between data of various blocks of databases and functional models of the choice of strategy of data balance form analytical base for justification of the choice of the direction of transformation of data. Models of a combination of a plurality of various data of the offer of products in the form of matrixes of multi-purpose optimization have double effect, because they allow not only to develop various options of data combina-tion, taking into account opportunities of change of location of products over the markets and temporary phases, but also to estimate aggregate useful effect from products. These models together with models of comparison of various options and the choice of optimal solutions allow to generate compatible strategic and current programs of the offer of products as a plurality of the output data balanced with each other and with data of demand. It is providing the best synergetic result. The developed methodology of creation of system of the interconnected digital models for transformation of data and generation of the output data of the situational-strategic program of the offer of products is a cornerstone of formation of new digital econ-omy – of economy of balanced data.
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Shabelnyk, Tetiana V., Serhii V. Krivenko, Nataliia Yu Rotanova, Oksana F. Diachenko, Iryna B. Tymofieieva, and Arnold E. Kiv. Integration of chatbots into the system of professional training of Masters. [б. в.], June 2021. http://dx.doi.org/10.31812/123456789/4439.

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The article presents and describes innovative technologies of training in the professional training of Masters. For high-quality training of students of technical specialties, it becomes necessary to rethink the purpose, results of studying and means of teaching professional disciplines in modern educational conditions. The experience of implementing the chatbot tool in teaching the discipline “Mathematical modeling of socio-economic systems” in the educational and professional program 124 System Analysis is described. The characteristics of the generalized structure of the chatbot information system for investment analysis are presented and given: input information, information processing system, output information, which creates a closed cycle (system) of direct and feedback interaction. The information processing system is represented by accounting and analytical data management blocks. The investment analysis chatbot will help masters of the specialty system analysis to manage the investment process efficiently based on making the right decisions, understanding investment analysis in the extensive structure of financial management and optimizing risks in these systems using a working mobile application. Also, the chatbot will allow you to systematically assess the disadvantages and advantages of investment projects or the direction of activity of a system analyst, while increasing interest in performing practical tasks. A set of software for developing a chatbot integrated into training is installed: Kotlin programming, a library for network interaction Retrofit, receiving and transmitting data, linking processes using the HTTP API. Based on the results of the study, it is noted that the impact of integrating a chatbot into the training of Masters ensures the development of their professional activities, which gives them the opportunity to be competent specialists and contributes to the organization of high-quality training.
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