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Articles de revues sur le sujet « Method Operable Design Region (MODR) »

Auteur : Grafiati

Publié le 7 juin 2025

Mis à jour le 2 août 2025

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Purva, Patel*1 Arjun Chaudhari2 Akash Patel1. "Discriminative Dissolution Development and Validation of Poorly Soluble Drugs Using Method Operable Design Region." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 950–65. https://doi.org/10.5281/zenodo.15350900.

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Establishing reliable and discriminative dissolution methods is critical for maintaining the quality and batch consistency of poorly soluble drug formulations—a process often hindered by conventional development techniques. This review emphasizes the transformative benefits of implementing structured Quality by Design (QbD) and Analytical QbD (aQbD) methodologies. By employing Design of Experiments (DoE), a Method Operable Design Region (MODR) can be optimized to guarantee method robustness. Additionally, implementing systematic evaluation protocols—such as defining a Method Discri

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Passerine, Bianca F. G., and Márcia C. Breitkreitz. "Important Aspects of the Design of Experiments and Data Treatment in the Analytical Quality by Design Framework for Chromatographic Method Development." Molecules 29, no. 24 (2024): 6057. https://doi.org/10.3390/molecules29246057.

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In the analytical quality by design (AQbD) framework, the design of experiments (DOE) plays a very important role, as it provides information about how experimental input variables influence critical method attributes. Based on the information obtained from the DOE, mathematical models are generated and used to build the method operable design region (MODR), which is a robust region of operability. Data treatment steps are usually carried out in software such as Fusion QbD, Minitab, or StaEase 360, among others. Although there are many studies in the literature that use the DOE, none of them a

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Alhakeem, Maher Abdulrazzaq, Mihaela Violeta Ghica, Cristina Dinu Pîrvu, Valentina Anuța, and Lăcrămioara Popa. "Analytical Quality by Design with the Lifecycle Approach: A Modern Epitome for Analytical Method Development." Acta Medica Marisiensis 65, no. 2 (2019): 37–44. http://dx.doi.org/10.2478/amma-2019-0010.

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AbstractQuality by Design is the methodical method to development concept that starts with the predefined objects. The method put emphasis on the process of development of a product, the control process, which is built on risk management and comprehensive knowledge of science. The concept of QbD applied to analytical method development is known now as AQbD (Analytical Quality by Design). Comprehension of the Analytical Target Profile (ATP) and the risk assessment for the variables that can have an impact on the productivity of the developed analytical method can be the main principles of the A

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Peraman, Ramalingam, Kalva Bhadraya, and Yiragamreddy Padmanabha Reddy. "Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics." International Journal of Analytical Chemistry 2015 (2015): 1–9. http://dx.doi.org/10.1155/2015/868727.

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Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design). It allows the analytical method for movement within method operable design region (MODR). Unlike current methods, analytical method developed using analytical quality by design (AQbD) approach reduces the number of out-of-trend (OOT) results and out-of-specification (OOS) results due to the robustness of t

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Wagh, Sneha Sunil* R. B. Darade. "Analytical Quality by Design: A Systematic Review." International Journal in Pharmaceutical Sciences 2, no. 5 (2024): 1120–26. https://doi.org/10.5281/zenodo.11235349.

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At various points throughout the life cycle of a pharmaceutical product, analytical procedures must be established. If these tasks are not appropriately simplified based on scientific knowledge and process understanding, it could result in an extremely expensive and time-consuming approach. The pharmaceutical industry is constantly looking for new guidelines or components to add to or replace the current components of the quality and risk management system The idea of Quality by Design was first introduced by renowned quality expert Joseph M. Juran. (QbD). Analytical method development, or AQb

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Walther, Rasmus, Jovana Krmar, Adrian Leistner, et al. "Analytical Quality by Design: Achieving Robustness of an LC-CAD Method for the Analysis of Non-Volatile Fatty Acids." Pharmaceuticals 16, no. 4 (2023): 478. http://dx.doi.org/10.3390/ph16040478.

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An alternative to the time-consuming and error-prone pharmacopoeial gas chromatography method for the analysis of fatty acids (FAs) is urgently needed. The objective was therefore to propose a robust liquid chromatography method with charged aerosol detection for the analysis of polysorbate 80 (PS80) and magnesium stearate. FAs with different numbers of carbon atoms in the chain necessitated the use of a gradient method with a Hypersil Gold C18 column and acetonitrile as organic modifier. The risk-based Analytical Quality by Design approach was applied to define the Method Operable Design Regi

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Basso, João, Maria Luísa Ramos, Alberto Pais, Rui Vitorino, Ana Fortuna, and Carla Vitorino. "Expediting Disulfiram Assays through a Systematic Analytical Quality by Design Approach." Chemosensors 9, no. 7 (2021): 172. http://dx.doi.org/10.3390/chemosensors9070172.

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An Analytical Quality by Design (AQbD) approach is presented, aiming at the development and validation of an HPLC method for the quantification of disulfiram and copper diethyldithiocarbamate in lipid nanoparticles. Following the definition of the analytical target profile (ATP), encompassing the critical analytical attributes (CAA), a two-level risk assessment strategy (Ishikawa diagram—failure mode and effect analysis (FMEA)) was employed to identify the critical method parameters (CMPs) with an extensive impact on method performance. The behavior of the CMPs (flow rate and mobile phase comp

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Mohammad, Tarikul Islam Bossunia, Farjana Urmi Khandokar, and Chironjit Kumar Shaha. "Quality-By-Design Approach to Stability Indicating RP-HPLC Analytical Method Development for Estimation of Canagliflozin API and Its Validation." Pharmaceutical Methods 8, no. 2 (2017): 01–10. https://doi.org/10.5281/zenodo.14856243.

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Context: Stability Indicating RP-HPLC analytical method validation for estimation of Canagliflozin API have been reported, but there are not studies related to the application of Analytical Quality by Design (AQbD) concepts to the development of a comprehensive science and risk based stability indicating RP-HPLC Analytical method for the analysis of Canagliflozin Active Pharmaceutical Ingredient (API). Aim: Development of a comprehensive science and risk based stability indicating RP-HPLC Analytical method for the analysis of Canagliflozin Active Pharmaceutical Ingredient (API) according to An

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Raman, N. V. V. S. S., Useni Reddy Mallu, and Hanimi Reddy Bapatu. "Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing." Journal of Chemistry 2015 (2015): 1–8. http://dx.doi.org/10.1155/2015/435129.

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Pharmaceutical industry has been emerging rapidly for the last decade by focusing on product Quality, Safety, and Efficacy. Pharmaceutical firms increased the number of product development by using scientific tools such as QbD (Quality by Design) and PAT (Process Analytical Technology). ICH guidelines Q8 to Q11 have discussed QbD implementation in API synthetic process and formulation development. ICH Q11 guidelines clearly discussed QbD approach for API synthesis with examples. Generic companies are implementing QbD approach in formulation development and even it is mandatory for USFDA perspe

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Gaytri, Anil More ¹* Shital Pande². "Formulation And Evaluation Of Ashwagandha Kalpa Of Ayurveda For Apasmara (Epilepsy)." International Journal in Pharmaceutical Sciences 2, no. 5 (2024): 1691–710. https://doi.org/10.5281/zenodo.11386977.

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At various points throughout the life cycle of a pharmaceutical product, analytical procedures must be established. If these tasks are not appropriately simplified based on scientific knowledge and process understanding, it could result in an extremely expensive and time-consuming approach. The pharmaceutical industry is constantly looking for new guidelines or components to add to or replace the current components of the quality and risk management system The idea of Quality by Design was first introduced by renowned quality expert Joseph M. Juran. (QbD). Analytical method development, or AQb

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Pavan, khonde Swati Jadhav* Aman Upaganlawar Chandrashekhar Upasani. "Cell and Gene Therapy in Cancer." International Journal in Pharmaceutical Sciences 2, no. 5 (2024): 1453–69. https://doi.org/10.5281/zenodo.11319242.

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At various points throughout the life cycle of a pharmaceutical product, analytical procedures must be established. If these tasks are not appropriately simplified based on scientific knowledge and process understanding, it could result in an extremely expensive and time-consuming approach. The pharmaceutical industry is constantly looking for new guidelines or components to add to or replace the current components of the quality and risk management system The idea of Quality by Design was first introduced by renowned quality expert Joseph M. Juran. (QbD). Analytical method development, or AQb

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Siddhant, M. Sawant* Prashant J. Burange Maithili P. Amale Pankaj H. Chaudhary. "A Review Article On Transforming Parkinson's Disease Care :Innovative Treatment Strategies Revealed." International Journal in Pharmaceutical Sciences 2, no. 5 (2024): 1522–43. https://doi.org/10.5281/zenodo.11351692.

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At various points throughout the life cycle of a pharmaceutical product, analytical procedures must be established. If these tasks are not appropriately simplified based on scientific knowledge and process understanding, it could result in an extremely expensive and time-consuming approach. The pharmaceutical industry is constantly looking for new guidelines or components to add to or replace the current components of the quality and risk management system The idea of Quality by Design was first introduced by renowned quality expert Joseph M. Juran. (QbD). Analytical method development, or AQb

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Aniket, Mohite* Dr. Deepak Kardile Swapnil Khopade Vaibhavi Kunjir Dr. Vishwas Bhagat Tushar Shinde Dr. Rajkumar Shete. "Quality by Design in RP-HPLC Method Development: Optimizing Performance and Robustness." International Journal of Pharmaceutical Sciences 3, no. 3 (2025): 3471–90. https://doi.org/10.5281/zenodo.15114639.

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Quality by Design (QbD) is&ensp;a science-based approach to method development that is built around the concept of designing in quality with crosstalk into all stages of the product lifecycle. In this review we discuss the use of QbD principles in RP-HPLC for Design space optimization and increasing both the performance and&ensp;the robustness. The QbD framework includes the following steps: identification and definition of Quality Target Product Profile (QTPP), determination of Critical Quality Attributes (CQAs) critical method parameters (CMPs), risk assessment (FMEA), method optimization (D

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Abudureheman, Kaidierya, Qinglin Wang, Hao Zhang, and Xingchu Gong. "Development of a QAMS Analysis Method for Industrial Lanolin Alcohol Based on the Concept of Analytical Quality by Design." Separations 11, no. 9 (2024): 276. http://dx.doi.org/10.3390/separations11090276.

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The Analytical Quality by Design (AQbD) concept was adopted to establish a quantitative analysis of multi-components with a single marker (QAMS) method for industrial lanolin alcohol, targeting cholesterol, lanosterol, and 24,25-dihydrolanosterol. The potential critical method parameters (CMPs) were identified as column temperature, flow rate, and gradient. Definitive screening design and statistical modeling were employed to optimize the gradient conditions of the mobile phase, column temperature, and flow rate. The Method Operable Design Region (MODR) was determined using a risk-based quanti

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Park, Geonha, Min Kyoung Kim, Seung Hyeon Go, Minsik Choi, and Young Pyo Jang. "Analytical Quality by Design (AQbD) Approach to the Development of Analytical Procedures for Medicinal Plants." Plants 11, no. 21 (2022): 2960. http://dx.doi.org/10.3390/plants11212960.

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Scientific regulatory systems with suitable analytical methods for monitoring quality, safety, and efficacy are essential in medicinal plant drug discovery. There have been only few attempts to adopt the analytical quality by design (AQbD) strategy in medicinal plants analysis over the last few years. AQbD is a holistic method and development approach that understands analytical procedure, from risk assessment to lifecycle management. The enhanced AQbD approach reduces the time and effort necessary to develop reliable analytical methods, leads to flexible change control through the method oper

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Bhosale, Abhilash, Shubhangi Darekar, V. U. Barge Dr., and Ashok Bhosale Dr. "Analytical Quality by Design Concise Review on Approach to Enhanced Analytical Method Development." International Journal of Trend in Scientific Research and Development 4, no. 3 (2020): 543–46. https://doi.org/10.5281/zenodo.3892381.

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In the last few decades, the pharmaceutical industry has been rapidly progressing by focussing on various aspects of formulation and analytical development such as product Quality, Safety, and Efficacy. It is reflected through the increase in number of product development by the increased use of scientific tools such as QbD Quality by Design and PAT Process Analytical Technology . ICH guidelines Q8 to Q11 have specified QbD implementation in API synthetic process and also in formulation as well as analytical development. QbD has earned considerable reputation by formulation developers. It has

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Liu, Sihan, Shaohua Wu, Hao Zhang, and Xingchu Gong. "Developing a Quantitative Profiling Method for Detecting Free Fatty Acids in Crude Lanolin Based on Analytical Quality by Design." Chemosensors 13, no. 4 (2025): 126. https://doi.org/10.3390/chemosensors13040126.

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In this study, a quantitative profiling method for detecting free fatty acids in crude lanolin based on the Quality by Design (QbD) concept was developed. High-performance liquid chromatography (HPLC) equipped with a charged aerosol detector (CAD) and a Proshell 120 EC C18 column was employed for the separation of crude lanolin components. Initially, the analytical target profile and critical method attributes were defined. Potential critical method parameters, including column temperature, flow rate, isocratic run time, gradient end organic phase ratio, and gradient time, were identified usin

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CHEERLA, JAYA RAJU, and T. BHASKARA RAO. "A Novel Approach to AQbD-Assisted Green and Robust UPLC Method for the Determination of Selected Aminoquinoline Antimalarial Drugs: Assessment of Green Method." Asian Journal of Chemistry 35, no. 10 (2023): 2517–26. http://dx.doi.org/10.14233/ajchem.2023.28204.

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Greening analytical procedures have gained popularity in the area of pharmaceutical industries in order to safeguard the environment. In this study, an innovative methodology by integrating analytical quality-by-design (AQbD) along with Green Chemistry concepts with a systematic approach has been used to develop an environmentally-friendly and more robust ultra performance liquid chromatography (UPLC) method for the determination of three selected aminoquinoline antimalarial drugs namely amodiaquine hydrochloride (AMD), chloroquine phosphate (CHQ) and piperaquine phosphate (PPQ). An environmen

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Vasquez-Huaman, Miguel, Américo Castro-Luna, Norma Julia Ramos-Cevallos, et al. "Increasing Analytical Quality by Designing a Thin-Layer Chromatography Scanner Method for the Determination of the Radiochemical Purity of Radiopharmaceutical Sodium Iodide 131I Oral Solution." Molecules 29, no. 8 (2024): 1883. http://dx.doi.org/10.3390/molecules29081883.

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The goal of this study was to apply the principles of analytical quality by design (AQbD) to the analytical method for determining the radiochemical purity (PQR) of the radiopharmaceutical sodium iodide 131I oral solution, utilizing thin-layer chromatography (TLC) with a radio–TLC scanner, which also enables the evaluation of product quality. For AQbD, the analytical target profile (ATP), critical quality attributes (CQA), risk management, and the method operable design region (MODR) were defined through response surface methodology to optimize the method using MINITAB® 19 software. This study

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Gurba-Bryśkiewicz, Lidia, Urszula Dawid, Damian A. Smuga, et al. "Implementation of QbD Approach to the Development of Chromatographic Methods for the Determination of Complete Impurity Profile of Substance on the Preclinical and Clinical Step of Drug Discovery Studies." International Journal of Molecular Sciences 23, no. 18 (2022): 10720. http://dx.doi.org/10.3390/ijms231810720.

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The purpose of this work was to demonstrate the use of the AQbD with the DOE approach to the methodical step-by-step development of a UHPLC method for the quantitative determination of the impurity profile of new CPL409116 substance (JAK/ROCK inhibitor) on the preclinical and clinical step of drug discovery studies. The critical method parameters (CMPs) have been tested extensively: the kind of stationary phase (8 different columns), pH of the aqueous mobile phase (2.6, 3.2, 4.0, 6.8), and start (20–25%) and stop (85–90%) percentage of organic mobile phase (ACN). The critical method attributes

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Li, Wenzhu, Jiayu Yang, Fang Zhao, Xinyuan Xie, Jianyang Pan, and Haibin Qu. "Application of the Analytical Procedure Lifecycle Concept to a Quantitative 1H NMR Method for Total Dammarane-Type Saponins." Pharmaceuticals 16, no. 7 (2023): 947. http://dx.doi.org/10.3390/ph16070947.

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Dammarane-type saponins (DTSs) exist in various medicinal plants, which are a class of active ingredients with effects on improving myocardial ischemia and immunomodulation. In this study, a quantitative 1H NMR method of total DTSs in herbal medicines was developed based on the analytical procedure lifecycle. In the first stage (analytical procedure design), the Ishikawa diagram and failure mode effects and criticality analysis were used to conduct risk identification and risk ranking. Plackett–Burman design and central composite design were used to screen and optimize critical analytical proc

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Zhao, Mintong, Yanni Tai, Gelin Wu, Feng Ding, Haibin Qu, and Xingchu Gong. "Integrated Application of Risk Management Techniques in Developing an Analysis Method for Traditional Chinese Medicine: A Case Study of a Percolation Solution for Xiaochaihu Capsules." Chemosensors 12, no. 8 (2024): 161. http://dx.doi.org/10.3390/chemosensors12080161.

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Risk management should run through the entire process of method development, utilization, and maintenance. Based on the analytical quality by design (AQbD) concept, various integrated risk management techniques were used in this study to develop an analysis method for the percolation solution of Xiaochaihu capsules. During the development of the analysis method, risk assessment was conducted using an Ishikawa diagram and failure mode effects analysis, followed by method optimization using experimental design. The probability of nonconformance calculated via an exhaustive Monte Carlo method qua

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Marzullo, Luca, Roberto Gotti, Serena Orlandini, et al. "Analytical Quality by Design-Compliant Development of a Cyclodextrin-Modified Micellar ElectroKinetic Chromatography Method for the Determination of Trimecaine and Its Impurities." Molecules 28, no. 12 (2023): 4747. http://dx.doi.org/10.3390/molecules28124747.

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In 2022, the International Council for Harmonisation released draft guidelines Q2(R2) and Q14, intending to specify the development and validation activities that should be carried out during the lifespan of an analytical technique addressed to assess the quality of medicinal products. In the present study, these recommendations were implemented in Capillary Electrophoresis method development for the quality control of a drug product containing trimecaine, by applying Analytical Quality by Design. According to the Analytical Target Profile, the procedure should be able to simultaneously quanti

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Freitas, Jorge, Pedro Silva, Paulo Vaz-Pires, and José S. Câmara. "A Systematic AQbD Approach for Optimization of the Most Influential Experimental Parameters on Analysis of Fish Spoilage-Related Volatile Amines." Foods 9, no. 9 (2020): 1321. http://dx.doi.org/10.3390/foods9091321.

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The volatile amines trimethylamine (TMA) and dimethylamine (DMA) could be used as important spoilage indices for seafood products, assisting in the determination of the rejection period. In the present study, a systematic analytical duality-by-design (AQbD) approach was used as a powerful strategy to optimize the most important experimental parameters of headspace solid-phase microextraction (HS-SPME) and gas chromatography-mass spectrometry (GC-MS) conditions for the quantification of TMA and DMA in Sparus aurata. This optimization enabled the selection of the best points in the method operab

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Li, Qing Chun, Wen Sheng Zhang, Ying Hua Zhang, Yu Dong Qiu, and Ye Hui Yang. "Coordinating Motion Planning for a Mobile Manipulator with Multiple Constraints." Applied Mechanics and Materials 442 (October 2013): 437–42. http://dx.doi.org/10.4028/www.scientific.net/amm.442.437.

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In this paper, we design a 6-degree of freedom (6-DOF) mobile manipulator and present a method of coordinating motion planning. Through analyzing the structure and motions of our mobile manipulator, we obtain some multiple constraints, including static constraints, dynamic constraints and obstacle constraints. To avoid the multiple results of inverse kinematics, joint angles constraints are adopted. Under the condition of these constraints, we put forward a method of coordinating motion planning to guarantee that the mobile manipulator can get the optimal solution by the maximum fitness method

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Patel, Kalpana, Hinal Jitendrabhai Patel, Jenee Christian, Lal Hingorani, and Tejal Gandhi. "Analytical QbD: Designing Space for HPLC Method Operable Region for Estimation of Preservatives in Herbal Formulation." Current Pharmaceutical Analysis 15, no. 2 (2019): 152–64. http://dx.doi.org/10.2174/1573412914666171218151224.

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Background: Quantification of preservatives in herbal formulation, simultaneously by high performance liquid chromatography analysis is very complex and involves series of steps including sample preparation, selection of suitable mobile phase and its validation for routine applications. </P><P> Introduction: Application of Quality by Design (QbD) in the development of novel, simple, accurate and precise RP-HPLC method for concurrent quantification of quaternary preservatives in herbal formulation, focusses on development of robust method. Methods: Isocratic analysis was carried out

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Stajić, A., J. Janković-Maksić, B. Jančić-Stojanović, and M. Medenica. "AQbD-Oriented UHPLC/MS/MS Method Development for Glycopeptides Assessment in Pharmaceutical Forms." Journal of Chromatographic Science 59, no. 7 (2021): 650–58. http://dx.doi.org/10.1093/chromsci/bmab004.

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Abstract Vancomycin and teicoplanin are glycopeptide antibacterials that inhibit the bacteria cell wall synthesis showing activity against gram-positive bacteria. Development of the sensitive method is of great importance for quality control of these drugs that are fermentation products. Modification of the fermentation conditions could cause the differences in the relative amount of the total substance or component, as it is the case with teicoplanin. The main objective of this study was development of the sensitive and effective ultra high performance liquid chromatography - tandem mass spre

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Kola, Hephzibah, and Sangeetha Shanmugasundaram. "Analytical quality by design-based RP-HPLC method for quantification of pioglitazone and candesartan cilexetil in bilayer tablet and its forced degradation studies." Pharmacia 70, no. 1 (2023): 27–37. http://dx.doi.org/10.3897/pharmacia.70.e95099.

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Aim: The current project involves developing an RP-HPLC method for simultaneous quantification of Candesartan Cilexetil and Pioglitazone based on analytical quality by design (AQbD). Materials and methods: When analysed in the Design Expert application, the critical method parameters were systematically refined using Central Composite Design and contours were derived for significant variables. A contour plot has been used to discover the technique operable design region that governs response variation, which is then empirically tested. Results: Successful chromatographic separation of title an

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Kola, Hephzibah, and Sangeetha Shanmugasundaram. "Analytical quality by design-based RP-HPLC method for quantification of pioglitazone and candesartan cilexetil in bilayer tablet and its forced degradation studies." Pharmacia 70, no. (1) (2023): 27–37. https://doi.org/10.3897/pharmacia.70.e95099.

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Aim: The current project involves developing an RP-HPLC method for simultaneous quantification of Candesartan Cilexetil and Pioglitazone based on analytical quality by design (AQbD). Materials and methods: When analysed in the Design Expert application, the critical method parameters were systematically refined using Central Composite Design and contours were derived for significant variables. A contour plot has been used to discover the technique operable design region that governs response variation, which is then empirically tested. Results: Successful chromatographic separation of title an

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Lan, Jing, Gelin Wu, Linlin Wu, et al. "Development of a Quantitative Chromatographic Fingerprint Analysis Method for Sugar Components of Xiaochaihu Capsules Based on Quality by Design Concept." Separations 10, no. 1 (2022): 13. http://dx.doi.org/10.3390/separations10010013.

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Background: Xiaochaihu capsule is composed of seven traditional Chinese medicines. The pharmacopoeia only focuses on the quantitative detection of baicalin, which cannot fully reflect the quality of the preparation. Some medium polar components were used to establish the fingerprint of Xiaochaihu capsule, but there was no report on the strong polar components. Methods: A high performance liquid chromatography-corona charged aerosol detection technology was used to establish a fingerprint analysis method for Xiaochaihu capsules following an analytical quality by design approach. Definitive scre

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Quamar, Danishtah, and Chiranjit Sarkar. "Optimal Design of Hydraulic Disc Brake for Magnetorheological (MR) Application." Defence Science Journal 72, no. 6 (2022): 783–92. http://dx.doi.org/10.14429/dsj.72.18369.

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This paper aims to provide a new design considering compressive force application in the MR fluid andimprove its braking torque by optimizing it. According to the current study, compressing the MR region will increase braking torque compared to no compression. The area covered by an existing model of the conventional disc brake is taken into consideration for the unique design of the MR brake to operate in shear and compression mode, and the required compression given by the hydraulic pressure similar to a conventional disc brake. The suggested MR brake’s structural layout is presented. The He

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Кононенко, К. Е., А. В. Кононенко, and С. Кетима. "RESEARCH OF THE FIELD IN A SYNCHRONOUS MACHINE WITH ELECTROMAGNETIC EXCITATION IN THE REGION OF SELF-OSCILLATIONS." ВЕСТНИК ВОРОНЕЖСКОГО ГОСУДАРСТВЕННОГО ТЕХНИЧЕСКОГО УНИВЕРСИТЕТА 20, no. 2 (2024): 35–38. http://dx.doi.org/10.36622/1729-6501.2024.20.2.006.

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известно, что при увеличении интенсивности магнитного поля в воздушном зазоре синхронная машина с электромагнитным возбуждением может войти в режим автоколебаний разной степени интенсивности. Исследованию автоколебаний было посвящено большое количество работ, однако магнитное поле в этой области исследовано не было. За исходное направление исследования принято разделение областей работы синхронной машины на области устойчивой работы, области автоколебаний и сползания, когда синхронная машина переходит в асинхронный режим. Кроме конструкции машины, области устойчивости зависят от параметров как

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Kaur, Ranjot, Sumant Saini, Asha Patel, et al. "Developing a Validated HPLC Method for Quantification of Ceftazidime Employing Analytical Quality by Design and Monte Carlo Simulations." Journal of AOAC INTERNATIONAL 104, no. 3 (2021): 620–32. http://dx.doi.org/10.1093/jaoacint/qsab014.

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Abstract Background Ceftazidime, a third-generation cephalosporin, is widely used in the treatment of lung infections, often given as “off-label” nebulization. There is a need to develop a sensitive and robust analytical method to compute aerodynamic properties of ceftazidime following nebulization. Objective The current study entails development of a simple, accurate, and sensitive HPLC method for ceftazidime estimation, employing the principles of analytical quality-by-design (AQbD) and Monte Carlo simulations. Method Selection of critical material attributes (CMAs) affecting method performa

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Azahra, Trisa, Ying-Ting Liao, Yi-Chien Chen, and Cheng-Chien Kuo. "Analysis of the Influence of Patch Antenna Shapes for Wireless Passive Temperature Sensor Applications." Applied Sciences 15, no. 6 (2025): 3136. https://doi.org/10.3390/app15063136.

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Wireless passive temperature sensors are essential in environments where wired connections are impractical, such as rotating machinery and harsh conditions. A key advantage of these sensors is their ability to operate without a local power source. This study employs the antenna backscattering method, which relies on the wireless interaction between the interrogator antenna and the sensor antenna’s resonant frequency, implemented in the far-field region to support long communication distances. To evaluate the impact of antenna shape on sensor performance, three microstrip patch antenna shapes—r

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Liu, Yu, Wenjie Wu, Pengfei Zhao, et al. "Highly Integrated Cladding Mode Stripper Array for Compact High-Power Industrial Fiber Laser." Micromachines 13, no. 12 (2022): 2226. http://dx.doi.org/10.3390/mi13122226.

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A design integrating multiple cladding mode strippers used in fiber laser architectures into a single device is proposed. This approach can increase the compactness of fiber lasers, thus contributing to industrial laser processing applications. By offset-placing the most intense light-stripping parts, for instance, by inversing the laser injection directions or by displacing the beginning of etched sections, multiple cladding mode strippers bundled together into a single housing can have the hottest regions separated and can operate at full power simultaneously, with no evident cross-influence

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Синицын, Сергей, Sergey Sinitsyn, Д. Стребков, D. Strebkov, Владимир Панченко, and Vladimir Panchenko. "Parquetting the Surface of a Parabolic Concentrator of a Solar Photovoltaic Thermal Module According to Given Differential- Geometric Requirements." Geometry & Graphics 7, no. 3 (2019): 15–27. http://dx.doi.org/10.12737/article_5dce6084f1ac94.09740392.

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The article discusses the geometric aspects of the design and creation of parabolic-type solar radiation concentrators. Practical methods of geometric design and manufacturing of concentrators of this kind are presented. Parabolic type concentrator is the main part of the solar photovoltaic thermal installation. Its effectiveness depends on the quality factors of the geometric shaping of the working surface, composed of a set of parquet components, linked to each other on the basis of differential geometric requirements. The distribution of illumination in the focal spot of such a concentrator

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Gomes, Vítor M. G., Grzegorz Lesiuk, José A. F. O. Correia, and Abílio M. P. de Jesus. "Fatigue Crack Propagation of 51CrV4 Steels for Leaf Spring Suspensions of Railway Freight Wagons." Materials 17, no. 8 (2024): 1831. http://dx.doi.org/10.3390/ma17081831.

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Leaf springs are critical components for the railway vehicle safety in which they are installed. Although these components are produced in high-strength alloyed steel and designed to operate under cyclic loading conditions in the high-cyclic fatigue region, their failure is still possible, which can lead to economic and human catastrophes. The aim of this document was to precisely characterise the mechanical crack growth behaviour of the chromium–vanadium alloyed steel representative of leaf springs under cyclic conditions, that is, the crack propagation in mode I. The common fatigue crack gro

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Kogut, A., I. Kuzmychov, G. Annino, et al. "OMNIDIRECTIONAL MILLIMETER-WAVELENGTH ANTENNAS BASED ON SEGMENTAL DIELECTRIC RESONATORS WHICH SUPPORT WHISPERING GALLERY MODES." RADIO PHYSICS AND RADIO ASTRONOMY 28, no. 1 (2023): 71–79. http://dx.doi.org/10.15407/rpra28.01.071.

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Subject and Purpose. The subject of investigation is a new class of resonant-type transmit antennas intended for operation at millimeter wavelengths. The model under consideration is based on the idea of diffractional re-emission of waves into the azimuthal direction by local inhomo-geneities of the basically cylindrical structure. The purpose of the work is to justify the possibility of using such an effect for creating antennas with a circular radiation pattern, and to suggest an appropriate design. Methods and Methodology. The research program included both experimental work and application

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A., Ibrar, Ahmad S., Safdar A., and Haroon N. "Efficiency enhancement strategy implementation in hybrid electric vehicles using sliding mode control." Electrical Engineering & Electromechanics, no. 1 (January 4, 2023): 10–19. https://doi.org/10.20998/2074-272X.2023.1.02.

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<strong><em>Introduction.</em></strong><em> Hybrid electric vehicles are offering the most economically viable choices in today's automotive industry, providing best solutions for a very high fuel economy and low rate of emissions. The rapid progress and development of this industry has prompted progress of human beings from primitive level to a very high industrial society where mobility used to be a fundamental need. However, the use of large number of automobiles is causing serious damage to our environment and human life. At present most of the vehicles are relying on burning of h

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Ibrar, A., S. Ahmad, A. Safdar, and N. Haroon. "Efficiency enhancement strategy implementation in hybrid electric vehicles using sliding mode control." Electrical Engineering & Electromechanics, no. 1 (January 4, 2023): 10–19. http://dx.doi.org/10.20998/2074-272x.2023.1.02.

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Introduction. Hybrid electric vehicles are offering the most economically viable choices in today's automotive industry, providing best solutions for a very high fuel economy and low rate of emissions. The rapid progress and development of this industry has prompted progress of human beings from primitive level to a very high industrial society where mobility used to be a fundamental need. However, the use of large number of automobiles is causing serious damage to our environment and human life. At present most of the vehicles are relying on burning of hydrocarbons in order to achieve power o

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Holyoake, Daniel, Maxwell Robinson, Victoria Y. Strauss, et al. "SPARC: A phase-I trial of pre-operative margin-intensified stereotactic radiotherapy for pancreatic cancer at high risk of positive resection margins." Journal of Clinical Oncology 36, no. 4_suppl (2018): TPS536. http://dx.doi.org/10.1200/jco.2018.36.4_suppl.tps536.

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TPS536 Background: Standard therapy for resectable and borderline resectable pancreatic cancer in the UK is surgery with adjuvant chemotherapy, but clear resection margins rates are unsatisfactory. Conventional neoadjuvant radiotherapy has limited efficacy, but stereotactic radiotherapy (SBRT) achieves accuracy and precision to enable dose escalation and margin-intensification, with the goal of achieving clear resection margins. This prospective multi-centre study aims to establish the maximum tolerated dose of margin-intensified pre-operative SBRT, for subsequent definitive comparison with ot

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Conceição, Calidon Costa, Francisco Antonio Dos Anjos, and Sara Joana Gadotti dos Anjos. "Power Relationship in the Governance of Regional Tourism Organizations in Brazil." Sustainability 11, no. 11 (2019): 3062. http://dx.doi.org/10.3390/su11113062.

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Objective: The development of tourism is one the main objectives of managers seeking a greater competitive advantage for destinations. To achieve this objective, the political-institutional structure related to public and private organizations involved in the Brazilian scenario of tourism activities deliberately operate in the format of Regional Tourism Organizations—RTOs, which started in 2004. In this context, the aim of this study arose, which is to analyze the power relations of Regional Tourism Organizations of tourist regions. Design/Methodology: This research adopted a qualitative and q

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Stone, T. W., J. Bennett, D. H. S. Law, and J. A. Holmes. "Thermal Simulation With Multisegment Wells." SPE Reservoir Evaluation & Engineering 5, no. 03 (2002): 206–18. http://dx.doi.org/10.2118/78131-pa.

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Summary The extension of a previously reported well model to compositional and thermal applications is discussed. This multisegment, multibranching wellbore model has been fully coupled to a commercial reservoir simulator that can operate in black-oil, compositional, or thermal modes. In this paper, the discussion will focus on thermal, heavy-oil applications in which simulation requires a better representation of the wellbore geometry and the physics of fluid flow and heat transfer. Introduction Gravity-drainage processes with possible steam (SAGD) or gas vapor (VAPEX) assistance and other re

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Boschee, Pam. "Comments: Geothermal Brines and Ocean Depths Hold Potential for Lithium." Journal of Petroleum Technology 76, no. 08 (2024): 8–9. http://dx.doi.org/10.2118/0824-0008-jpt.

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_ OTC 35088 presented a direct lithium extraction (DLE) technology based on electrodialysis, developed by Alma Energy and The University of Texas at El Paso. This technology uses ion-selective membranes to extract lithium from geothermal brines and is described as also potentially producing green hydrogen, fresh water, and sequestering CO2. The technology leverages chlor-alkali electrodialysis, a method using an electric field to separate ions through membranes, adapted for DLE from natural geothermal brines. The proprietary selective membrane system separates lithium from other brine componen

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Doan Thanh Xuan and Vu Dang Hoang. "Analytical Quality-by-Design approach for HPLC analysis of pharmaceutical mixtures: case studies." Tạp chí Nghiên cứu Dược và Thông tin Thuốc 17 (June 19, 2024). http://dx.doi.org/10.59882/1859-364x/171.

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Analytical Quality-by-Design (AQbD) is a methodical approach to method development, which is relatively novel to the analytical scientists. It oversees every phase of the analytical procedure's lifecycle by defining the Analytical Target Profile (ATP), pinpointing critical method parameters (CMPs) or factors, and choosing critical method attributes (CMAs) or responses. Utilizing screening and response-surface experimental designs enables the identification and optimization of significant factors through statistical analysis. It helps establish the design space or Method Operable Design Region

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Chen, Hongbo, Rui Wang, and John-David McElderry. "Discriminative Dissolution Method Development Through an aQbD Approach." AAPS PharmSciTech 24, no. 8 (2023). http://dx.doi.org/10.1208/s12249-023-02692-8.

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AbstractUsing a one-factor-at-a-time approach for dissolution method and discrimination analysis can be time-consuming and may not yield the optimal and discriminative method. To address this, we have developed a two-stage workflow for the dissolution method development followed by demonstration of discrimination power through an analytical Quality by Design (aQbD) approach. In the first stage, an optimal dissolution method was achieved by determining the method operable design region (MODR) through a design of experiment study of the high-risk method-related parameters. In the second stage, w

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Dong, Yongzhi, Zhimin Liu, Charles Li, et al. "Perspectives in modeling and model validation during analytical quality by design chromatographic method evaluation: a case study." AAPS Open 7, no. 1 (2021). http://dx.doi.org/10.1186/s41120-021-00037-y.

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AbstractDesign of experiments (DOE)-based analytical quality by design (AQbD) method evaluation, development, and validation is gaining momentum and has the potential to create robust chromatographic methods through deeper understanding and control of variability. In this paper, a case study is used to explore the pros, cons, and pitfalls of using various chromatographic responses as modeling targets during a DOE-based AQbD approach. The case study involves evaluation of a reverse phase gradient HPLC method by a modified circumscribed central composite (CCC) response surface DOE.Solid models w

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P., Abhinandana1.2* Ramarao Nadendla2. "IMPLEMENTING OF ANALYTICAL QUALITY BY DESIGN FOR HIGH QUALITY PHARMACEUTICAL PRODUCTS." July 31, 2017. https://doi.org/10.5281/zenodo.2526723.

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The quality in the pharmaceutical industry has become a very important topic. Pharmaceutical industry has been emerging rapidly for the last decade by focusing on product Quality, Safety, and Efficacy. The guidelines of ICH from Q8 to Q11 have discussed QbD implementation in pharmaceutical product formulation development. ICH Q11 is a clear discussion about QbD approach for API (Active Pharmaceutical Ingredient) synthesis with examples. Pharmaceutical firms increased the number of product development by using different scientific tools such as QbD (Quality by Design) and PAT (Process Analytica

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Marie, Aya A., Sherin F. Hammad, Mohamed M. Salim, Mahmoud M. Elkhodary, and Amira H. Kamal. "Deduction of the operable design space of RP-HPLC technique for the simultaneous estimation of metformin, pioglitazone, and glimepiride." Scientific Reports 13, no. 1 (2023). http://dx.doi.org/10.1038/s41598-023-30051-x.

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AbstractA reversed-phase RP-HPLC method was developed for the simultaneous determination of metformin hydrochloride (MET), pioglitazone (PIO), and glimepiride (GLM) in their combined dosage forms and spiked human plasma. Quality risk management principles for determining the critical method parameters (CMPs) and fractional factorial design were made to screen CMPs and subsequently, the Box–Behnken design was employed. The analytical Quality by Design (AQbD) paradigm was used to establish the method operable design region (MODR) for the developed method depended on understanding the quality tar

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Rukhshanda, HABIB 1. 2. 3., AKHLAQ 1. Muhammad, SHAHNAZ 3. Gul, et al. "Quality-By-Design Based HPLC Method Development and Validation for Separation of Levosulpiride from Dosage Forms and Pharmacokinetic in Humans." January 27, 2021. https://doi.org/10.5281/zenodo.7477220.

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A novel quality by design-based high performance liquid chromatographic method was developed for levosulpiride. There was no specific method for levosulpiride in United States Pharmacopeia. So, for the first time Quality by Design approach was implemented by Box- Behnken Design. Method specifications include; buffer (low molarity): acetonitrile (50:50), column c18, pH 7 and flow rate 0.6 mL/min. Use of low molarity buffer increases the column life, 3.8 min fast retention time as compared with previously reported methods. A highly statistical significant model was obtained by employing Box- Beh

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