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Relevant bibliographies by topics / Method Operable Design Region (MODR)

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Academic literature on the topic 'Method Operable Design Region (MODR)'

Author: Grafiati

Published: 7 June 2025

Last updated: 2 August 2025

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Journal articles on the topic "Method Operable Design Region (MODR)"

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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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Book chapters on the topic "Method Operable Design Region (MODR)"

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Mahr, Amanda Guiraldelli, Felipe Rebello Lourenço, Phil Borman, Jane Weitzel, and Jean-Marc Roussel. "Analytical Target Profile (ATP) and Method Operable Design Region (MODR)." In AAPS Introductions in the Pharmaceutical Sciences. Springer International Publishing, 2023. http://dx.doi.org/10.1007/978-3-031-31505-3_9.

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Conference papers on the topic "Method Operable Design Region (MODR)"

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Carcasci, C., L. Marini, M. Micio, R. Brogelli, and P. L. Di Pillo. "Modular Tool for Design and Off-Design Analysis of Compression Trains for Oil and Gas Applications." In ASME Turbo Expo 2016: Turbomachinery Technical Conference and Exposition. American Society of Mechanical Engineers, 2016. http://dx.doi.org/10.1115/gt2016-57771.

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Compression trains for oil and gas applications must meet, now more than ever, the requirement of versatility. Production rates and compression demands of extraction fields significantly change during their operational life; this has pushed customers to ask for equipments designed to efficiently operate all over their lifespan in order to comply with energy saving and pollution reduction needs. For this reason modular simulation codes turn out to be the best choice compared with dedicated tools for specific compression plant configuration, since they provide flexibility without losing accuracy

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Guo, Wei, and Henry Guo. "Thermal Mechanical Fatigue and Creep Interaction in Turbine Housing Divider Wall Design." In ASME Turbo Expo 2016: Turbomachinery Technical Conference and Exposition. American Society of Mechanical Engineers, 2016. http://dx.doi.org/10.1115/gt2016-56409.

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Turbochargers are commonly used to boost internal combustion engines for both on and off high way applications to meet current emission regulations and performance requirements. Divider wall turbochargers have two exhaust gas inlets and twin scrolls with the divider cast wall connected. Turbochargers with divider wall feature could conserve an engine’s exhaust pulse kinetic energy for great turbine wheel efficiency. It is widely used in 6-cylinder engine applications. Turbochargers with divider wall configuration operate in very hostile conditions with high temperature and great thermal gradie

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Angello, Leonard, Bobby Noble, Rob Steele, Mitch Cohen, and Benjamin Emerson. "Dry Low NOx (DLN) Combustion System Operability Considerations." In ASME Turbo Expo 2022: Turbomachinery Technical Conference and Exposition. American Society of Mechanical Engineers, 2022. http://dx.doi.org/10.1115/gt2022-82667.

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Abstract Modern gas turbines employ dry low NOx (DLN) combustion systems to reduce air pollution and meet stringent environmental regulations. Gas turbine DLN combustion systems operate in lean premix mode near the extinction limit. In this region, the quantity of fuel in the air/fuel mix at the burner is barely sufficient to sustain combustion at low flame temperatures. Safe and reliable operation of modern combustors near the flame extinction limit requires a number of vital elements: 1) an in-depth understanding of mechanisms that promote combustion stability at these extremely low fuel equ

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Young, Stanley, Rick Grahn, and Andrew Duvall. "A Multi-Dimensional Benefit Assessment of Automated Mobility Platforms (AMP) for Large Facilities: Mobility, Energy, Equity, and Facility Management & Design." In Energy & Mobility Technology, Systems, and Value Chain Conference and Expo. SAE International, 2023. http://dx.doi.org/10.4271/2023-01-1512.

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<div class="section abstract"><div class="htmlview paragraph">The goal of the <b>automated mobility platforms (AMPs)</b> initiative is to raise the bar of service regarding equity and sustainability for public mobility systems that are crucial to large facilities, and doing so using electrified, energy efficient technology. Using airports as an example, the rapid growth in air travel demand has led to facility expansions and congested terminals, which directly impacts equity (e.g., increased challenges for Passengers with Reduced Mobility [PRMs]) and sustainability—both

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