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Analytical Physicochemical and Functional Studies to Compare AryoTrust, a Follow-On Biologics, with the Originator Trastuzumab (Herceptin)
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Background: Trastuzumab is a blockbuster monoclonal antibody that has revolutionized the treatment of HER2-positive breast and gastric cancers. With the increasing availability of biosimilar monoclonal antibodies in clinical practice, independent verification of biosimilarity using products sampled from a real-world supply chain is important to assure clinicians and the patients to use these products confidently. Objective: The aim of this study is to assess the biosimilarity of AryoTrust, a trastuzumab biosimilar, in comparison with the reference product Herceptin. AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings. Methods: AryoTrust and Herceptin were compared using an extensive set of orthogonal analytical techniques which included SDS-PAGE, ion-exchange chromatography, capillary isoelectric focusing, peptide mapping, N-glycan profiling, circular dichroism, differential scanning calorimetry, and surface plasmon resonance. In addition to these teste, functional comparability was also tested using an HER2-dependent cell-based proliferation inhibition bioassay. Results: The results showed that both products have highly comparable profiles in all assessed attributes. The analysis showed similar molecular integrity and purity, identical primary structure, comparable charge heterogeneity, similar isoelectric points (pI) of the main isoform, close glycosylation patterns (mainly, by core-fucosylated complex-type glycans), similar higher-order structural features, and thermal stability. The receptor binding studies exhibited comparable binding affinities with Fcγ receptors and FcRn. Finally, the cell-based bioassay revealed comparable dose–response curves with similar EC50 values and relative potency. Conclusions: The integrated analytical and functional data support the biosimilarity of AryoTrust to the reference product Herceptin, which has been marketed and used in Iraq. This study provides real-world scientific evidence supporting confidence in the quality and comparability of this trastuzumab biosimilar and reduces any doubt in the product and at the same time emphasizes the value of independent post-marketing biosimilarity assessments.

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Publication Date
Sat Dec 01 2012
Journal Name
Journal Of Economics And Administrative Sciences
An analytical study of the reality of chemical industries in Iraq for the period (1995-2007)
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Is the chemical industries of great importance for the economy of any country, through what is borne by these industries is an important part of the changes contained in the industrial output of transfer and, moreover, that these industries are overlaps and intricacies of sector-wide with the rest of the manufacturing sectors, with agriculture and services , through the offering of these industries produce Production requirements intervention such as chemical fertilizer used in the production of agricultural crops, in addition to the various areas for the use of phosphorus in the food industry, to the extent that it is difficult to find material Food preparation is not included i

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Publication Date
Mon Nov 30 2020
Journal Name
Journal Of Economics And Administrative Sciences
Impact the Organizational downsizing in organizational health: Analytical research in the Directorate of Education in Nineveh
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This research aims to determine the extent of the contribution of organizational downsizing strategies to enhance the health of the researched organization represented by the Directorate of Education in Nineveh, and to achieve this goal, the study provided a simplified intellectual framework for the most important topics covered by writers and researchers for search variables, reinforced by an applied analytical framework for the opinions of (79) individuals responsible for the researched organization. The research adopted organizational downsizing as an independent variable that includes three dimensions represented by (reduction of human resources, job redesign, systemic strategy), while the organizational health represented th

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Publication Date
Tue Jan 02 2024
Journal Name
Eximia Journal
The role of strategic Renewal in organizational immunity - analytical research in the Iraqi Ministry of Education
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The current study aims to demonstrate the role of strategic renewal in enhancing organizational immunity through strategic renewal mechanisms represented by (Reanimating, Rejuvenation, Venturing, and restructuring). The main idea of this study relates to the extent to which organizations’ immunity is achieved through strategic Renewal mechanisms, by measuring these dimensions with Organizational immunity represented by organizational learning, organizational memory, and organizational DNA. The study population was the headquarters of the Iraqi Ministry of Education, and the sample included (330) individuals from the upper, middle, and lower leadership levels. Several statistical methods were used to deal with the results of the questionna

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Publication Date
Thu Dec 26 2019
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Health insurance services in the sustainability of human resources: )Analytical study in the Iraqi insurance company)
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Health insurance and its benefits are of great importance and impact on the employees who represent the human capital of each organization because they are related to the health reality. The study took into account the most important and the last of his writing of the concepts and literary reviews and enriched the theoretical part of the practical side has addressed the financial data and analysis for the period from 2013 to 2017 to know the impact and the relationship between the variables that They were reviewed on the theoretical side. The study came out with a number of results, on the basis of which practical conclusions were drawn and reflected what was observed on the basis of which the recommendations were formulated

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Publication Date
Fri Jun 30 2023
Journal Name
حوليات أداب عين شمس
The role of artistic elements in revealing psychological emotions in the play (Gan Riki) (Analytical review)
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Our research sheds light on one of the most important aspects of David Grossman's play, "Ricky's Garden, גן ריקי " which is characterized by its realistic portrayal of characters. Grossman gradually moves towards the inner awareness of his characters, expressing their emotions and thoughts through conversations and emotional conflicts, referring to their past and rooted background. Grossman transformed the main subject of his play (psychological depth) into a presentation and arrangement of all the elements of the play in a way that expresses emotional nature more powerfully by each child in the garden. This is reflected in their actions and words, making Grossman's works suitable for study and always of interest to specialized resear

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Publication Date
Tue Aug 01 2017
Journal Name
Journal Of Economics And Administrative Sciences
Effective administrative leadership in the implementation of public policies: Analytical look at the Baghdad Provincial Council
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Abstract

      The current research aims to find out the role of administrative leadership in the implementation of public policies and their effectiveness and their ability to do so, As well as analysis and testing of influence and correlations between research variables, The researcher has the descriptive and analytical approach, And several tools used to gather information consisted of personal interviews and field visits, While distributed questionnaire tool that consists of (35) items on a sample consisting of (147) individuals formed of staff of the Baghdad Provincial Council.

The research was based on a set of assum

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Publication Date
Fri Dec 13 2024
Journal Name
Journal Of Economics And Administrative Sciences
The role of strategic sensitivity in organizational immunity - analytical research in the Iraqi Ministry of Education
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The current research aims to find out the effect of strategic sensitivity in enhancing organizational immunity at the leadership levels in the Iraqi Ministry of Education, as the strategic sensitivity variable includes two dimensions (strategic foresight and strategic Insight), and the organizational immunity variable addresses three dimensions (organizational learning, organizational memory and organizational DNA). The main purpose of this research was related to the extent to which the Ministry’s immunity was achieved through the role played by strategic sensitivity. A sample of (349) individuals was selected . The questionnaire was relied upon to collect data, and the number of questionnaires suitable for analysis was (330). Re

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Publication Date
Thu Aug 01 2019
Journal Name
Journal Of Economics And Administrative Sciences
Economic contributions to small industrial projects (Selected international experiences with special reference to Iraq)
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Abstract:

Most of the studies on this subject, small industrial projects, by researchers and scholars in the economic field show the great and increasing importance of doing this kind of projects, the extent of which can be determined by the contribution of these projects to indicators and macroeconomic and sectorial variables. So this research aims to show the extent of the economic contribution of projects in selected international experiences and in the Iraqi economy. As international experiences have provided the opportunity for the progress and growth of small projects in their economies, which led to an increase in the contribution of these projects in the recruitment of economically active manpower, in added

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Publication Date
Wed Sep 11 2024
Journal Name
Lecture Notes In Civil Engineering
An Image Processing Algorithm to Address the Problem of Stains Merge on Water Sensitive Papers and Its Impact on the Evaluation of Spray Quality Indicators
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There are many techniques that can be used to estimate the spray quality traits such as the spray coverage, droplet density, droplet count, and droplet diameter. One of the most common techniques is to use water sensitive papers (WSP) as a spray collector on field conditions and analyzing them using several software. However, possible merger of some droplets could occur after they deposit on WSP, and this could affect the accuracy of the results. In this research, image processing technique was used for better estimation of the spray traits, and to overcome the problem of droplet merger. The droplets were classified as non-merged and merged droplets based on their roundness, then the merged droplets were separated based on the average non-m

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Publication Date
Sat Dec 03 2016
Journal Name
Journal Of Genetic And Environmental Resources Conservation
Examination the efficiency of NDVI index by comparing with STVI-4 index to recognize the vegetation cover
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