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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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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
Fri Apr 22 2022
Journal Name
Periodicals Of Engineering And Natural Sciences (pen)
Developing models to predicting the effect of crises on construction projects using MLR technique
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Publication Date
Sat Apr 01 2017
Journal Name
International Journal Of Science And Research
Evaluating the Behavior of Ring Footing on Two-Layered Soil Subjected to Inclined Load
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Evaluating the behavior of a ring foundation resting on multi-layered soil is one of the important issues facing civil engineers. Many researchers have studied the behavior of ring foundation rests on multi-layered soil with vertical loads acting on the foundation. In real life ring foundation can be subjected to both vertical and horizontal loads at the same time due to wind or the presence of soil. In this research, the behavior of ring footing subjected to inclined load has been studied using PLAXIS software. Furthermore, the effect of multi-layered soil has been simulated in the model. The results showed that both vertical and horizontal stresses are mainly affected when the inclination angle of the load exceeded 45 degrees with a reduc

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Publication Date
Sun Jan 01 2023
Journal Name
Corporate Governance And Organizational Behavior Review
Impact of the electronic internal auditing based on IT governance to reduce auditing risk
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This paper analysed the effect of electronic internal auditing (EIA) based on the Control Objectives for Information and Related Technologies (COBIT) framework. Organisations must implement an up-to-date accounting information system (AIS) capable of meeting their auditing requirements. Electronic audit risk (compliance assessment, control assurance, and risk assessment) is a development by Weidenmier and Ramamoorti (2006) to improve AIS. In order to fulfil the study’s objectives, a questionnaire was prepared and distributed to a sample comprising 120 employees. The employees were financial managers, internal auditors, and workers involved in the company’s information security departments in the General Company for Electricity D

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Publication Date
Sun Dec 09 2018
Journal Name
Baghdad Science Journal
Proposing an Analysis System to Monitoring Weightlifting Based on Training (Snatch and Clean and Jerk)
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Analysis system of sports players is very important for individuals in weightlifting. Assessment of player and strength is important for the performance of weightlifting. This paper proposes an analytical method for weightlifters with check-by-frame video. This analysis system can compute the major steps of seven positions in both snatch and clean and jerk methods in frame-video weightlifting monitoring of movements. Each user can compute the major steps of the seven positions of Hu moments among two frames in the video during training, and the Euclidian distance can be computed for the Hu moment values and lifting moment values in the snatch and clean and jerk methods during training. The outcome of the proposed system shows on efficien

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Publication Date
Thu Jan 25 2024
Journal Name
Entrepreneurship Journal For Fiinance And Business
The role of psychological ownerships' dimensions in deterring the effects of toxic leadership: Analytical research in some companies at the Ministry of Industry and Minerals in Iraq
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The research aims to clarify the role that psychological ownership, through its dimensions, plays in deterring the effects of toxic leadership, through its dimensions, in the Ministry of Industry and Minerals. The research started with a basic problem represented by the following question: "Using psychological ownership and its application in deterring the negative effects of toxic leadership." The research used the descriptive-analytical method. The sample was randomly selected from workers in some selected companies affiliated with the Ministry of Industry and Minerals in Baghdad, and the sample size reached 124 individuals. One of the most important results is that there is an effect of the psychological ownership variable, based on the

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Publication Date
Mon Jun 01 2015
Journal Name
Journal Of Economics And Administrative Sciences
Theories of the structure of modern finance : practical application of pecking order theory and the life cycle of the company/analytical research of asmple of foreign companies
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 Is the subject of the financial structure of the most important topics for which she received the interests of scientific research in the field of financial management , as it emerged several theories about choosing a financial structure appropriate for the facility and behavior change funding them , and in spite of that there is no agreement on a specific theory answer various questions in this regard , and a special issue of the financial structure optimization.

The objective of the research was to identify the most important theories of the structure of modern financial theory has been to focus on the capture of financial firms in two different stages of their life cycle , so-called growth and ma

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Publication Date
Mon Feb 13 2023
Journal Name
Journal Of Educational And Psychological Researches
The Reality of Using Electronic Applications in Teaching Language Skills to People with Mild Intellectual Disability from the Mothers’ Perspective
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Abstract

This study aims to identify the reality of using electronic applications in teaching language skills to people with mild intellectual disabilities from the mothers’ perspective. A descriptive approach was used. The electronic questionnaires were administered to the study sample, 122 responses were received from mothers of the students with mild intellectual disability in Hafer Al-Baten schools. The response average rate was 94%. The results showed that there are statistically significant differences that are related to the variant of monthly income as for the barriers to using electronic applications in such schools, whereas there were no differences regarding the variant of monthly income regarding t

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Publication Date
Tue Aug 22 2023
Journal Name
Microbial Science Archives
Unveiling Westiellopsis akinetica: a novel species in the Iraqi habitat, and contrasting its distinctive attributes with Westiellopsis prolifica
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This is the first record of a new species of cyanobacteria Westiellopsis akinetica in the Iraqi environment, Samples were collected on June 2013 and the existence of it was not documented before. We isolated and purified this species ten years ago in Iraq, but we couldn't identify accurately based on all taxonomic handbooks. This is due to the species features being different from the other documented species in the available taxonomic lectures. It resembled many species by morphological characteristics such as Fischerella muscicola, Fischerella thermalis, Westiellopsis biateralis SA16. Westiellopsis interrupta, Westiellopsis persica SA33, Westiellopsis prolifica and Symphyonema bifilamentata. Describing a new species of the Westiellops

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Publication Date
Sun Jan 01 2023
Journal Name
Journal Of Population Therapeutics And Clinical Pharmacology
Evaluation of the Expression of RCC and KIM-1 Biomarkers in Nephrotoxicity of Rabbits Treated with Ochratoxins A
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Publication Date
Sun Sep 04 2016
Journal Name
Baghdad Science Journal
A Study the Effect of TiO2 Nanoparticles Combination with Antibiotics and Plant extracts Against Some Gram Negative Bacteria
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Titanium dioxide TiO2 has been widely utilized in cleaning and sterilizing material for many clinical tools sanitary ware, food tableware and cooking and items for use in hospitals. Titanium dioxide TiO2 non toxicity and long term physical and chemical stability. It has been widely used decomposition of organic compounds and microbial organisms such as cancer cell, viruses and bacteria as well as its potential application in sterilization of medical devices. The aim of the study the effect of titanium dioxide TiO2 on some Gram negative bacteria and study their effects on some virulence factors and chromosomal DNA.In this study, we obtained (E. coli ? Proteus mirabilis, Proteus vulgaris ? Pseudomonas aeruginosa ? Klebsiella pneumonia and Ac

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