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Journal articles on the topic 'And Approaches of Process Validation'

Author: Grafiati

Published: 2 June 2025

Last updated: 31 July 2025

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1

Richa Shukla, Dr. Nimita Manocha, and Dr. Gurmeet Singh Chhabra. "Theoretical Approaches to Process Validation in Pharmaceutical Manufacturing Process." International Journal of Scientific Research in Science and Technology 11, no. 2 (2024): 573–85. http://dx.doi.org/10.32628/ijsrst52411229.

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Under the more general statutory CGMP provisions of section 501(a)(2)(B) of the Federal Food, Drug and Cosmetic Act, validation of manufacturing processes is deemed a legal part of current good manufacturing practice for active pharmaceutical ingredients (APIs). Validation of manufacturing processes is required by the Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR 211.100 and 211.110). A medication should be created that is suitable for its intended purpose, according to the fundamental tenet of quality assurance. Procedure Validation is the collect

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Pratibha, Thapliyal* Neha Sodiyal Shivanand Patil. "A Review on Process Validation of Pharmaceutical Tablet." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 4393–401. https://doi.org/10.5281/zenodo.15518879.

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This review aims to outline the effects of effective process validation in the pharmaceutical sector. Pharmaceutical tablets are the solid oral dosage form widely used for the prevention, diagnosis, and mitigation of disease. Process validation refers to the documented proof that a manufacturing process reliably yields a product that meets established specifications and quality attributes. The main objective of process validation is to guarantee that pharmaceutical products are consistently safe, effective, and of superior quality. This process focuses on enhancing the safety and quality of th

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Vaibhav*, Obed Singh Shivanand Patil. "A Review on Process Validation of Ursodeoxycholic Acid Tablets Ip 300 Mg." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 3524–31. https://doi.org/10.5281/zenodo.15476783.

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Pharmaceutical Validation is one of the important processes in achieving and maintaining the quality of the final drug product. If each step of the manufacturing/packing process is validated, then we can ensure that the final product is of the best quality. Pharmaceutical Process validation is an essential component for the safety of drug product and to maintain the quality of the product. Validation is establishing documented evidence which provides a high degree of assurance that a specific process for manufacturing tablets will consistently produce a product meeting its pre-determined speci

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L., P. Jain*1 M. S. Charde1 S. J. Momin1 S. V. Potdar2 N. D. Kulkarni1. "Quality by Design in HPTLC: A Review of Method Development Approaches." International Journal of Scientific Research and Technology 2 (June 3, 2025): 179–97. https://doi.org/10.5281/zenodo.15585927.

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A methodical approach to development, Quality by Design (QbD) starts with predetermined goals for a product, process comprehension, and process control based on knowledge and quality risk management. When developing and validating a traditional approach, it is possible that it will not achieve the desired outcome. AQbD is the application of the QbD idea to the validation of analytical  methods. A systematic and trustworthy strategy for developing analytical processes that cover all stages of a product's lifecycle is offered by AQbD.  The AQbD technique for creating the HPTLC method i

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Buranathiti, Thaweepat, Jian Cao, Wei Chen, Lusine Baghdasaryan, and Z. Cedric Xia. "Approaches for Model Validation: Methodology and Illustration on a Sheet Metal Flanging Process." Journal of Manufacturing Science and Engineering 128, no. 2 (2006): 588–97. http://dx.doi.org/10.1115/1.1807852.

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Model validation has become an increasingly important issue in the decision-making process for model development, as numerical simulations have widely demonstrated their benefits in reducing development time and cost. Frequently, the trustworthiness of models is inevitably questioned in this competitive and demanding world. By definition, model validation is a means to systematically establish a level of confidence of models. To demonstrate the processes of model validation for simulation-based models, a sheet metal flanging process is used as an example with the objective that is to predict t

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Choi, Wansuk, and Seoyoon Heo. "Deep Learning Approaches to Automated Video Classification of Upper Limb Tension Test." Healthcare 9, no. 11 (2021): 1579. http://dx.doi.org/10.3390/healthcare9111579.

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The purpose of this study was to classify ULTT videos through transfer learning with pre-trained deep learning models and compare the performance of the models. We conducted transfer learning by combining a pre-trained convolution neural network (CNN) model into a Python-produced deep learning process. Videos were processed on YouTube and 103,116 frames converted from video clips were analyzed. In the modeling implementation, the process of importing the required modules, performing the necessary data preprocessing for training, defining the model, compiling, model creation, and model fit were

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Yung, S. K., and D. W. Clarke. "Local Sensor Validation." Measurement and Control 22, no. 5 (1989): 132–41. http://dx.doi.org/10.1177/002029408902200502.

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Current approaches to plant fault detection require an overall process model. This paper argues that a hierarchical scheme is more efficient in which the lowest level concentrates on validating the signals transmitted by individual sensors. Signals are described in terms of standard time-series models. A fault is defined by the signal's deviation from its expected behaviour and various signal processing techniques are described which detect these aberrations.

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Spring, Gary S. "Critical Review of Expert System Validation in Transportation." Transportation Research Record: Journal of the Transportation Research Board 1588, no. 1 (1997): 104–9. http://dx.doi.org/10.3141/1588-13.

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Expert system validation—that is, testing systems to ascertain whether they achieve acceptable performance levels—has with few exceptions been ad hoc, informal, and of dubious value. Very few efforts have been made in this regard in the transportation area. A discussion of the major issues involved in validating expert systems is provided, as is a review of the work that has been done in this area. The review includes a definition of validation within the context of the overall evaluation process, descriptions and critiques of several approaches to validation, and descriptions of guidelines th

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Pimenov, Denis, Alexander Solovyov, Nursultan Askarbekuly, and Manuel Mazzara. "Data-Driven Approaches to User Interface Design: A Case Study." Journal of Physics: Conference Series 2134, no. 1 (2021): 012020. http://dx.doi.org/10.1088/1742-6596/2134/1/012020.

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Abstract The most common reason for software product failure is misunderstanding user needs. Analysing and validating user needs before developing a product can allow to prevent such failures. This paper investigates several data-driven techniques for user research and product design through prototyping, customer validation, and usability testing. The authors implemented a case study software product using the proposed techniques, and analyses how the application of UX/UI research techniques affected the development process. The case study results indicate that preliminary UX/UI research befor

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Rajamanickam, Vignesh, Heiko Babel, Liliana Montano-Herrera, et al. "About Model Validation in Bioprocessing." Processes 9, no. 6 (2021): 961. http://dx.doi.org/10.3390/pr9060961.

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In bioprocess engineering the Qualtiy by Design (QbD) initiative encourages the use of models to define design spaces. However, clear guidelines on how models for QbD are validated are still missing. In this review we provide a comprehensive overview of the validation methods, mathematical approaches, and metrics currently applied in bioprocess modeling. The methods cover analytics for data used for modeling, model training and selection, measures for predictiveness, and model uncertainties. We point out the general issues in model validation and calibration for different types of models and p

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Nguyen, Tan-Nhu, Marie-Christine Ho Ba Tho, and Tien-Tuan Dao. "A Systematic Review of Real-Time Medical Simulations with Soft-Tissue Deformation: Computational Approaches, Interaction Devices, System Architectures, and Clinical Validations." Applied Bionics and Biomechanics 2020 (February 20, 2020): 1–30. http://dx.doi.org/10.1155/2020/5039329.

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Simulating deformations of soft tissues is a complex engineering task, and it is even more difficult when facing the constraint between computation speed and system accuracy. However, literature lacks of a holistic review of all necessary aspects (computational approaches, interaction devices, system architectures, and clinical validations) for developing an effective system of soft-tissue simulations. This paper summarizes and analyses recent achievements of resolving these issues to estimate general trends and weakness for future developments. A systematic review process was conducted using

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Lindner, Marlit Annalena, and Samuel Greiff. "Process Data in Computer-Based Assessment." European Journal of Psychological Assessment 39, no. 4 (2023): 241–51. http://dx.doi.org/10.1027/1015-5759/a000790.

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Abstract: This editorial provides a comprehensive framework and overview of potential uses and next steps in research on process data in computer-based assessments, expanding toward broad perspectives on the field and an exploration of future directions and emerging trends. After briefly reflecting on the evolution of process data use in research and assessment practice, we discuss three key challenges, namely (1) the theoretical grounding and validation of process data indicators, (2) assessment design for process data, and (3) ethical standards. By considering best practice approaches in all

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Shah, Devanshi, Vinit Movaliya, Shruti Kharidia, and Maitreyi Zaveri. "Comparative Study of Analytical Method Validation and Process Validation parameters as per ICH, EMA, WHO and ASEAN guidelines." International Journal of Drug Regulatory Affairs 12, no. 2 (2024): 58–64. http://dx.doi.org/10.22270/ijdra.v12i2.675.

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Objective: Compare and analyse analytical method validation and process validation requirements across ICH, EMA, WHO, and ASEAN guidelines, alongside relevant literature. Summary: In the pharmaceutical industry, ensuring the quality, safety, and effectiveness of medicinal products is of utmost importance. Analytical Method Validation (AMV) and Process Validation (PV) are critical procedures in pharmaceutical manufacturing, vital for upholding product quality and adhering to regulatory standards. This thesis undertakes a comparative examination of AMV and PV guidelines from prominent regulatory

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Augusto, Adriano, Marlon Dumas, Marcello La Rosa, Sander J. J. Leemans, and Seppe K. L. M. vanden Broucke. "Optimization framework for DFG-based automated process discovery approaches." Software and Systems Modeling 20, no. 4 (2021): 1245–70. http://dx.doi.org/10.1007/s10270-020-00846-x.

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AbstractThe problem of automatically discovering business process models from event logs has been intensely investigated in the past two decades, leading to a wide range of approaches that strike various trade-offs between accuracy, model complexity, and execution time. A few studies have suggested that the accuracy of automated process discovery approaches can be enhanced by means of metaheuristic optimization techniques. However, these studies have remained at the level of proposals without validation on real-life datasets or they have only considered one metaheuristic in isolation. This art

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McEvoy, Brian, Stacy Bohl Wiehle, Ken Gordon, Gerry Kearns, Paulo Laranjeira, and Nicole McLees. "Advancing the Sustainable Use of Ethylene Oxide through Process Validation." Biomedical Instrumentation & Technology 55, s3 (2021): 35–44. http://dx.doi.org/10.2345/0899-8205-55.s3.35.

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Abstract Based on excellent material compatibility and ability for scale, ethylene oxide (EO) sterilization constitutes approximately 50% of single-use medical device sterilization globally. Epidemiological considerations have elevated focus toward optimization of EO processes, whereby only necessary amounts of sterilant are used in routine processing. EO sterilization of medical devices is validated in accordance with AAMI/ANSI/ISO 11135:2014 via a manner in which a sterility assurance level (SAL) of 10−6 is typically achieved, with multiple layers of conservativeness delivered, using “overki

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Cousens, Leslie, Leonard Moise, Frances Terry, William Martin, and Anne De Groot. "Immunogenic biologics: validation of screening, deimmunization and tolerization approaches (P3251)." Journal of Immunology 190, no. 1_Supplement (2013): 192.11. http://dx.doi.org/10.4049/jimmunol.190.supp.192.11.

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Abstract Immune responses directed against protein therapeutics can directly impact drug pharmacology, safety and efficacy. While many factors contribute to protein immunogenicity, T cell-dependent responses play a critical role. Tools to predict and reduce T cell responses to protein therapeutics present benefits at every stage of drug development. We provide evidence for two different approaches to mitigate therapeutic protein immunogenicity: epitope modification and antigen-specific tolerance induction. Following a systematic process of in silico epitope mapping applied to either Factor VII

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Gupta, N. Vishal, Nataraj Hm, and Ravi G. "VALIDATION OF WATER PURIFICATION SYSTEM." Asian Journal of Pharmaceutical and Clinical Research 10, no. 4 (2017): 409. http://dx.doi.org/10.22159/ajpcr.2017.v10i4.16955.

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Objective: Validation of water treatment systems is required to achieve water with all preferred quality attributes. This also delivers a circumstantial to establish a total control over the process which screens efficacy, safety, and ultimately, the process outcomes. The goal of steering validation is to establish that a process when operated within established limits, yields a product of reliable and definite quality with a high degree of assurance.Methods: The current work is an effort to deliberate several aspects of validation comprising different approaches, machineries of water purifica

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Alkemade, Anneke, Martijn J. Mulder, Anne C. Trutti, and Birte U. Forstmann. "Manual delineation approaches for direct imaging of the subcortex." Brain Structure and Function 227, no. 1 (2021): 219–97. http://dx.doi.org/10.1007/s00429-021-02400-x.

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AbstractThe growing interest in the human subcortex is accompanied by an increasing number of parcellation procedures to identify deep brain structures in magnetic resonance imaging (MRI) contrasts. Manual procedures continue to form the gold standard for parcellating brain structures and is used for the validation of automated approaches. Performing manual parcellations is a tedious process which requires a systematic and reproducible approach. For this purpose, we created a series of protocols for the anatomical delineation of 21 individual subcortical structures. The intelligibility of the

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19

Boykov, V. N., A. Yu Reshetko, and A. Yu Kotov. "NEW APPROACHES TO EVALUATING DESIGN SOLUTIONS IN INFORMATION MODELING ROADS." Roads and Bridges 53, no. 1 (2025): 201–14. https://doi.org/10.70991/1815-896x-2025-1-53-201-214.

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The article discusses new possibilities for evaluating design solutions provided by three-dimensional object models of roads obtained in the process of information modeling. Generalized assessments of the quality of design solutions through analysis of estimated speeds, capacity, safety factors and accident rates are being replaced by collision checking, verification and validation of design solutions. Some examples of evaluating design solutions that were previously unavailable for implementation in two-dimensional design conditions are given.

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Poynton, Timothy A., Bernalyn Ruiz, and Richard T. Lapan. "Development and Validation of the College Admissions Knowledge Evaluation." Professional School Counseling 22, no. 1b (2019): 2156759X1983444. http://dx.doi.org/10.1177/2156759x19834441.

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This article describes the process used to develop a new measure of college knowledge and the findings from an initial study to examine the measure’s construct validity. We employed common test construction (item response theory, classical test theory) and factor analytic (exploratory factor analysis, confirmatory factor analysis) approaches to analyzing the data from 519 graduating high school seniors; these analyses support the construct validity of the measure. We discuss the importance of college knowledge in the college decision-making process and implications for school counseling practi

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Maier, Michael, Michael Pusterhofer, and Florian Grün. "Modelling Approaches of Wear-Based Surface Development and Their Experimental Validation." Lubricants 10, no. 12 (2022): 335. http://dx.doi.org/10.3390/lubricants10120335.

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Surface topography has a significant influence on the friction behaviour in lubricated contacts. During running-in, the surface topography is continuously changed. The surface structure influences the contact stiffness (asperity contact pressure) as well as the microhydrodynamics (flow factors). In this study, different models for wear simulation of real rough surfaces were created in Matlab© (MathWorks, Natick, MA) and Abaqus© (ABAQUS Inc., Palo Alto, CA, USA) using the Usersubroutine Umeshmotion. The arithmetic mean height Sa(wh), the maximum height Sz(wh), as well as the asperity contact pr

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Seter, Zehava, and Cristian Stan. "Educational Change - Easy to Say, Hard to Do: Teachers’ Perceptions towards Introducing Innovative Teaching Approaches." Educatia 21, no. 19 (December 19, 2020): 127–36. http://dx.doi.org/10.24193/ed21.2020.19.16.

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"Computers, communication, and internet technologies have led to significant changes in learning and teaching. The constructivist approach in education puts learners at the center of the teaching process and actively makes them construct their knowledge, developing 21st century skills required for tomorrow’s world. Despite advances in the process of integrating technology into teaching, a significant gap still exists between promise and actual reality. Implementation of computer technologies depends on many complex factors, one of which is teachers’ perceptions of assimilating computerization

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Benin, Andrea L., Ada Fenick, Jeph Herrin, Grace Vitkauskas, John Chen, and Cynthia Brandt. "How Good Are the Data? Feasible Approach to Validation of Metrics of Quality Derived From an Outpatient Electronic Health Record." American Journal of Medical Quality 26, no. 6 (2011): 441–51. http://dx.doi.org/10.1177/1062860611403136.

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Although electronic health records (EHRs) promise to be efficient resources for measuring metrics of quality, they are not designed for such population-based analyses. Thus, extracting meaningful clinical data from them is not straightforward. To avoid poorly executed measurements, standardized methods to measure and to validate metrics of quality are needed. This study provides and evaluates a use case for a generally applicable approach to validating quality metrics measured electronically from EHR-based data. The authors iteratively refined and validated 4 outpatient quality metrics and cla

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Ghosh, Manimay. "A3 Process: A Pragmatic Problem-Solving Technique for Process Improvement in Health Care." Journal of Health Management 14, no. 1 (2012): 1–11. http://dx.doi.org/10.1177/097206341101400101.

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Short-term approaches or patch working are the predominant modes of solving process-related problems in organizations. As a result, problems recur at regular intervals and inhibit their smooth functioning. Organizational leaders have adopted various quality initiatives to produce sustainable change, but the existing literature suggests that many of them have met with limited success. The ‘A3 Process’, adapted from Toyota Motor Corporation, has been proposed as a pragmatic problem-solving technique for creating sustainable organizational change. Observing, drawing iconic sketches, discussing wi

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Javanaiah, Nagarathna, Sarakanuru Krishnappa Srinath, and Ananya Shetty. "Validation Process of New Behavior Management Technique during Local Anesthesia in Children with Dental Anxiety." Indian Journal of Dental Research 36, no. 1 (2025): 21–25. https://doi.org/10.4103/ijdr.ijdr_189_24.

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Abstract Background: Developing methodological approaches and instrumentation in psychological research is critical since the variables and constructs in the field are diverse and must be assessed with appropriate instruments. Each instrument produced or altered must undergo content validation. The content validation method involves a readability test to determine whether the questions or items accurately represent the assessed constructs or variables. Aim: This study aimed to illustrate the steps involved in content translation, adaptation, and validation of Mindful Attention Instruction Scri

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Guiguet, Andres, and Dirk Pons. "A Validation Framework for Bulk Distribution Logistics Simulation Models." Logistics 9, no. 1 (2024): 3. https://doi.org/10.3390/logistics9010003.

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Background: Simulation of business processes allows decision-makers to explore the implications and trade-offs of alternative approaches, policies and configurations. Trust in the simulation as a stand-in proxy of the real system depends on the validation of the computer model as well as on that of the data used to run it and judge its behaviour. Though validation frameworks exist, they provide little guidance for validation in the context of data-poor endeavours, such as those where observations as sourced from historical records were acquired for purposes other than the simulation itself. As

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Arias, Michael, Rodrigo Saavedra, Maira R. Marques, Jorge Munoz-Gama, and Marcos Sepúlveda. "Human resource allocation in business process management and process mining." Management Decision 56, no. 2 (2018): 376–405. http://dx.doi.org/10.1108/md-05-2017-0476.

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Purpose Human resource allocation is considered a relevant problem in business process management (BPM). The successful allocation of available resources for the execution of process activities can impact on process performance, reduce costs and obtain a better productivity of the resources. In particular, process mining is an emerging discipline that allows improvement of the resource allocation based on the analysis of historical data. The purpose of this paper is to provide a broad review of primary studies published in the research area of human resource allocation in BPM and process minin

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Reinhart, Gunther, and Peter Stich. "Approaches for the Simulation of Deformable Objects in Manufacturing Systems." Industrial and Systems Engineering Review 1, no. 1 (2013): 68–74. http://dx.doi.org/10.37266/iser.2013v1i1.pp68-74.

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The validation of control software using methods of Virtual Commissioning (VC), with its origin in the field of machine tools, gains more and more importance in other application areas like process engineering or material-flow-intensive production systems. Especially because of the increasing complexity of technical systems the validation of the control software quality is a major challenge in production technology. To reduce the efforts of modeling and to increase the value of simulation results, a so-called physically model is integrated in the VC. Currently the physically based Virtual Comm

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Pekic, Jasmina, Jovana Milutinovic, and Biljana Lungulov. "Approaches to higher education teaching: validation of the Serbian adaptation of the approaches to teaching inventory - revised (ATI-R)." Zbornik Instituta za pedagoska istrazivanja 56, no. 1 (2024): 99–121. http://dx.doi.org/10.2298/zipi2401099p.

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The aim of the conducted research was the construct validation of the Serbian translation of the Approaches to Teaching Inventory - Revised (ATI-R), in the domain of exploring the factor structure, which was shown to be remarkably unstable in earlier research of this kind. In addition, since the previous examinations of the ATI-R psychometric properties were mainly reduced to reliability, the second goal of the research includes psychometric validation of the instrument in the domain of reliability, validity, representativeness and homogeneity. The research was conducted on a random sample of

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Hernández-Molinos, María José, Angel J. Sánchez-García, Rocío Erandi Barrientos-Martínez, Juan Carlos Pérez-Arriaga, and Jorge Octavio Ocharán-Hernández. "Software Defect Prediction with Bayesian Approaches." Mathematics 11, no. 11 (2023): 2524. http://dx.doi.org/10.3390/math11112524.

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Software defect prediction is an important area in software engineering because it helps developers identify and fix problems before they become costly and hard-to-fix bugs. Early detection of software defects helps save time and money in the software development process and ensures the quality of the final product. This research aims to evaluate three algorithms to build Bayesian Networks to classify whether a project is prone to defects. The choice is based on the fact that the most used approach in the literature is Naive Bayes, but no works use Bayesian Networks. Thus, K2, Hill Climbing, a

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De Gruttola, Victor, and Andrea S. Foulkes. "Validation and Discovery in Markov Models of Genetics Data." Statistical Applications in Genetics and Molecular Biology 3, no. 1 (2004): 1–15. http://dx.doi.org/10.2202/1544-6115.1104.

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Markov models provide a natural framework for modeling cellular and molecular level changes over time. Kalbfleisch and Lawless propose using a Chi-squared statistic for assessing the appropriateness of assuming a first-order, homogeneous Markov process. While this statistic provides a global test of the Markov assumption, it does not permit identification of individual departures. We consider two approaches for discovering specific departures from the Markov assumption. First, we propose a diagnostic that tests whether the number of observed transitions out of a given state at a given time poi

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Stavropoulos, Panagiotis, and Vasiliki Christina Panagiotopoulou. "Developing a Framework for Using Molecular Dynamics in Additive Manufacturing Process Modelling." Modelling 3, no. 1 (2022): 189–200. http://dx.doi.org/10.3390/modelling3010013.

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Additive Manufacturing (AM), or else Smart Manufacturing, has been an intrinsic concept in Industry 4.0, offering flexibility and material efficiency. Certain limitations prevent AM from being used in the industrial setting extensively, despite its advantages. Therefore, a literature review on the process modelling approaches, their advantages and limitations was performed. The most frequently used process modelling approaches were reviewed and summarized with respect to the process modelling approach, scale and limitations. The different categories of process modelling approaches were compare

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Morev, E. A. "MODERN METHODS OF PRODUCT DEVELOPMENT IN THE FACE OF MARKET VOLATILITY." Business Strategies 9, no. 9 (2021): 271–75. http://dx.doi.org/10.17747/2311-7184-2021-9-271-275.

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This paper examines modern methods and approaches to product development in the context of the volatility of the world market. To achieve maximum customer focus and successful delivery of their products, services and services, more and more companies are focusing on flexible approaches to product development. The changing business environment and the emergence of new mechanisms of interaction with customers lead to the need to create approaches such as "Lean Startup". Its core principle is a validation process in each product development process, which will increase the ability to create a bet

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Reich, Eike, Anne Schibli, and Alison DeBatt. "Validation of High-Performance Thin-Layer Chromatographic Methods for the Identification of Botanicals in a cGMP Environment." Journal of AOAC INTERNATIONAL 91, no. 1 (2008): 13–20. http://dx.doi.org/10.1093/jaoac/91.1.13.

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Abstract Current Good Manufacturing Practices (cGMP) for botanicals stipulates the use of appropriate methods for identification of raw materials. Due to natural variability, chemical analysis of plant material is a great challenge and requires special approaches. This paper presents a comprehensive proposal to the process of validating qualitative high-performance thin-layer chromatographic (HPTLC) methods, proving that such methods are suitable for the purpose. The steps of the validation process are discussed and illustrated with examples taken from a project aiming at validation of methods

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Ramli, Nur Farhana, Othman Talib, Siti Aishah Hassan, and Umi Kalthom Abdul Manaf. "Development and Validation of an Instrument to Measure STEM Teachers’ Instructional Preparedness." Asian Journal of University Education 16, no. 3 (2020): 193. http://dx.doi.org/10.24191/ajue.v16i3.11084.

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STEM education curriculum is an effort mainly targeted for stakeholders to increase students' interest in STEM as well as to meet future workforce demand. Teachers’ instructional preparations are an important part to the overall effectiveness of the teaching and learning process. This study focuses on the development and validation process of STEM Teachers' Instructional Preparedness Instrument (STEMTIP). The study comprises ten steps ranging from development to validation phase. Social constructivist theory, 5E instructional model and STEM teaching and learning approach model were used as the

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Stratonova, N. V., A. S. Lisov, A. N. Morozov, D. V. Tyupa, and R. A. Khamitov. "Methodological Approaches to Validation of Therapeutic Recombinant Proteins Production Based on the Quality by Design Concept." BIOpreparations. Prevention, Diagnosis, Treatment 18, no. 3 (2018): 175–83. http://dx.doi.org/10.30895/2221-996x-2018-18-3-175-183.

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Validation of production processes based on the Quality by Design (QbD) principles calls for thorough scientific understanding of the processes and enhancement of their stability by implementation of new technologies. The aim of the study consisted in substantiating a QbD-based technological approach to validation of commercial production of dornase alfa. For this purpose a design space was established in a scale-down model, i.e. 2 L reactors; the model was shown to be representative in terms of all parameters except for the reactor size; the similarity of hydrodynamic conditions, design chara

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KHARIS, SELLY ANASTASSIA AMELLIA, and ARMAN HAQQI ANNA ZILI. "Predicting life expectancy of lung cancer patients after thoracic surgery using SMOTE and machine learning approaches." Jurnal Natural 23, no. 3 (2023): 152–61. http://dx.doi.org/10.24815/jn.v23i3.29144.

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. Lung cancer is a life-threatening condition characterized by the uncontrolled growth and spread of abnormal cells in the lungs. Thoracic surgery is a commonly employed diagnostic and treatment procedure for lung cancer. The objective of this study is to utilize machine learning techniques to predict the life expectancy of lung cancer patients one year after thoraric surgery. The study utilizes the Thoraric Surgery Data Set, consisting of 454 data, with 385 data representing surviving patients and 69 data representing patients who passed away. Due to an imbalance in the data, the Synthetic Mi

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Ferenczi-Fodor, Katalin, Zoltán Végh, Anikó Nagy-Turák, Bernd Renger, and Marco Zeller. "Validation and Quality Assurance of Planar Chromatographic Procedures in Pharmaceutical Analysis." Journal of AOAC INTERNATIONAL 84, no. 4 (2001): 1265–76. http://dx.doi.org/10.1093/jaoac/84.4.1265.

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Abstract Within the process of the International Conference on Harmonization (ICH), 2 guidelines were released containing a standardized terminology, a verified model of requirements for the validation of analytical procedures, and some guidance in the practical aspects of conducting validation studies in pharmaceutical analysis. For planar chromatographic procedures, which may be used at different levels either in qualitative identity testing, assays, semiquantitative limit tests, or quantitative determination of impurities, this paper tries to transfer these formal requirements into practica

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Ding, Yan, and Julie D. Rosati. "VALIDATION OF INTEGRATED COASTAL PROCESS MODEL FOR SIMULATING WAVE-CURRENT-VEGETATION INTERACTION." Coastal Engineering Proceedings, no. 36 (December 30, 2018): 73. http://dx.doi.org/10.9753/icce.v36.currents.73.

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Vegetation plays an important role in reducing wetland and coastal erosion. It is well-known that vegetation in coastal regions acts as a buffer to reduce wave impact and wave setup, as waves are deformed and energy of waves is attenuated through vegetation zones. Modeling wave deformation and transformation through vegetation zones can quantify wave attenuation effects as a function of vegetation properties, improve our understanding of physical processes, and eventually provide an effective assessment tool for management, control, and design of vegetation zones and wetlands. Wave attenuation

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Hubbart, Jason A. "Improving Best Management Practice Decisions in Mixed Land Use and/or Municipal Watersheds: Should Approaches Be Standardized?" Land 10, no. 12 (2021): 1402. http://dx.doi.org/10.3390/land10121402.

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Best management practices (BMP) are defined in the United States Clean Water Act (CWA) as practices or measures that have been demonstrated to be successful in protecting a given water resource from nonpoint source pollution. Unfortunately, the greatest majority of BMPs remain unvalidated in terms of demonstrations of success. Further, there is not a broadly accepted or standardized process of BMP implementation and monitoring methods. Conceivably, if standardized BMP validations were a possibility, practices would be much more transferrable, comparable, and prescriptive. The purpose of this b

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Ahrenhold, Nils, Izabela Stasicka, Rabeb Abdellaoui, Thorsten Mühlhausen, and Marco-Michael Temme. "Enabling Green Approaches by FMS-AMAN Coordination." Aerospace 10, no. 3 (2023): 278. http://dx.doi.org/10.3390/aerospace10030278.

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Growing political pressure and widespread social concerns about climate change are triggering a paradigm shift in the aviation sector. Projects with the target of reducing aviation’s CO2 emissions and their impact on climate change are being launched to improve currently used procedures. In this paper, a new coordination process between aircraft flight management systems (FMSs) and an arrival manager (AMAN) was investigated to enable fuel-efficient and more sustainable approaches. This coordination posed two major challenges. Firstly, current capacity-centred AMANs’ planning processes are not

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Beck, Cheryl T., and Robert K. Gable. "Ensuring Content Validity: An Illustration of the Process." Journal of Nursing Measurement 9, no. 2 (2001): 201–15. http://dx.doi.org/10.1891/1061-3749.9.2.201.

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Assessing content validity is one of the most critical steps in instrument development. Neither statistical elegance nor sophisticated measurement strategies are substitutes for validity. Systematic in-depth approaches to the assessment of content validity are needed, including a priori and a posteriori procedures. In this manuscript the a priori approach of specifying an instrument’s content domain is addressed along with the a posteriori procedure of having a panel of judges assess the validation of the items. This article focuses on the process used to assess the content validity. Data from

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Keller, J., and Z. Yuan. "Combined hydraulic and biological modelling and full-scale validation of SBR process." Water Science and Technology 45, no. 6 (2002): 219–28. http://dx.doi.org/10.2166/wst.2002.0109.

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The biological reactions during the settling and decant periods of Sequencing Batch Reactors (SBRs) are generally ignored as they are not easily measured or described by modelling approaches. However, important processes are taking place, and in particular when the influent is fed into the bottom of the reactor at the same time (one of the main features of the UniFed process), the inclusion of these stages is crucial for accurate process predictions. Due to the vertical stratification of both liquid and solid components, a one-dimensional hydraulic model is combined with a modified ASM 2d biol

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Paulo, Rui Miguel Batista, Jiong Lin, Nagui M. Rouphail, and Jerome Sacks. "Calibrating and Validating Deterministic Traffic Models." Transportation Research Record: Journal of the Transportation Research Board 1920, no. 1 (2005): 95–105. http://dx.doi.org/10.1177/0361198105192000112.

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Calibration and validation of traffic models are processes that depend on field data that are often limited but are essential for determination of inputs to the model and assessment of its reliability. Quantification and systematization of the calibration and validation process expose statistical issues inherent in the use of such data. Formalization of the calibration and validation process naturally leads to the use of Bayesian methodology for assessment of uncertainties in model predictions that arise from a multiplicity of sources, especially statistical variability in estimation and calib

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Sayali, V. Ganjiwale* A. P. Dewani A. V. Chandewar. "A Comprehensive Overview Of HPLC Method Development And Validation." International Journal in Pharmaceutical Sciences 2, no. 1 (2024): 802–11. https://doi.org/10.5281/zenodo.10581387.

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HPLC has become the workhorse of analytical separations due to its versatility, sensitivity, and precision. However, optimizing and validating an HPLC method for specific analytes requires an intricate adjustment of parameters. This review provides a comprehensive overview of the key steps involved in developing and validating a robust HPLC method. Initially, we delve into the critical factors influencing method development, including analyte properties, sample preparation strategies, column selection, mobile phase optimization, and detector choice. We detail the importance of resolution, peak

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Muharto, Bambang, Frendy Rian Saputro, Wargiantoro Prabowo, et al. "Pyrolysis process control: temperature control design and application for optimum process operation." International Journal of Electrical and Computer Engineering (IJECE) 14, no. 2 (2024): 1473. http://dx.doi.org/10.11591/ijece.v14i2.pp1473-1485.

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Fast pyrolysis in auger reactor gains attention for efficient bio-oil production. Due to the quick nature of the process, precise temperature control using the proportional-integral-derivative (PID) algorithm is paramount. This study harnesses various PID tuning approaches through modelling and experimental validation to optimize continuous and precise pyrolysis temperature. System identification was done to investigate the process dynamic with fit accuracy above 93% and design a suitable PID control. Comparison with the experiment data shows a favorable result with rise time and settling time

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Muharto, Bambang, Frendy Rian Saputro, Wargiantoro Prabowo, et al. "Pyrolysis process control: temperature control design and application for optimum process operation." International Journal of Electrical and Computer Engineering (IJECE) 14, no. 2 (2024): 1473–85. https://doi.org/10.11591/ijece.v14i2.pp1473-1485.

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Fast pyrolysis in auger reactor gains attention for efficient bio-oil production. Due to the quick nature of the process, precise temperature control using the proportional-integral-derivative (PID) algorithm is paramount. This study harnesses various PID tuning approaches through modelling and experimental validation to optimize continuous and precise pyrolysis temperature. System identification was done to investigate the process dynamic with fit accuracy above 93% and design a suitable PID control. Comparison with the experiment data shows a favorable result with rise time and settling time

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Suebsombut, Paweena, Aicha Sekhari, Pradorn Sureephong, Abdelhak Belhi, and Abdelaziz Bouras. "Field Data Forecasting Using LSTM and Bi-LSTM Approaches." Applied Sciences 11, no. 24 (2021): 11820. http://dx.doi.org/10.3390/app112411820.

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Water, an essential resource for crop production, is becoming increasingly scarce, while cropland continues to expand due to the world’s population growth. Proper irrigation scheduling has been shown to help farmers improve crop yield and quality, resulting in more sustainable water consumption. Soil Moisture (SM), which indicates the amount of water in the soil, is one of the most important crop irrigation parameters. In terms of water usage optimization and crop yield, estimating future soil moisture (forecasting) is an essentially valuable task for crop irrigation. As a result, farmers can

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M. Damnjanović, Aleksandar, Milan D. Rašković, and Dušan M. Janković. "LEADERSHIP APPROACHES IN MANAGING AI-DRIVEN PROCESS AUTOMATION FOR SMALL AND MEDIUM-SIZED ENTERPRISES." SCIENCE International Journal 3, no. 4 (2024): 47–51. https://doi.org/10.35120/sciencej0304047d.

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The analysis conducted in this paper aims to enhance the understanding of leadership roles in managing human resource automation changes in small and medium-sized enterprises (SMEs). A prerequisite for this analysis was the development of descriptive statistical parameters to organize collected data based on common sample characteristics, particularly in the context of automation and its impact on human resource management. Various statistical learning methods were applied throughout the paper to analyze and interpret the variables required for this level of research. The analysis followed suc

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Torres, Mauricio, Saúl Piedra, Saúl Ledesma, Carlos Escalante-Velázquez, and Giovanni Angelucci. "Manufacturing Process of High Performance—Low Cost Composite Structures for Light Sport Aircrafts." Aerospace 6, no. 2 (2019): 11. http://dx.doi.org/10.3390/aerospace6020011.

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This work describes the technological and scientific efforts on designing, manufacturing and testing validation for high performance-low cost composite structures for Light Sport Aircrafts (LSA). A Mexican initiative to conceive, manufacture and assembly a Light Sport Aircraft has been developed by using Computational Fluid Dynamics (CFD), Finite Element Analysis (FEA) and Liquid Composite Manufacturing (LCM). These consolidated techniques are used to characterize novel approaches to manufacturing and assembly carbon-fiber based structural components. As large structures are manufactured via V

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