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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
This research aims to clarify the advantages of using the regression method as analytical procedure in the tax audit to reducing the examination cost , time, effort, human and material resources, and represents an applied study in the General Commission of taxes. In order to achieve its objectives the research has used in the theoretical side the descriptive approach (analytical), and in the practical side regression method has been applied to the research sample represented by the soft drinks company that is subject to the tax settlement for the year 2014, where the value of sales has been verified by using the regression method without conductinga comprehensive examination. The most important results of the research indicate that the r
... Show Moreأن إحدى اكبر مشاكل الصحة العالمية هي ظهور مقاومة الميكروبية للأدوية الشائعة لذلك هناك حاجة ملحة لمضادات جرثومية جديدة ذات نشاط أحيائي معزز .في هذا الدراسة, تم تحضير خمسة مشتقات جديدة من الكينولين A,B,C,D وEكمضادات جرثومية. تم فحص بنية المركبات المحضرة باستخدام UV light , FTIR NMR . تم استخدام طريقة الانتشار بالحفر في الطبق لاختبار الخصائص المضادة للبكتريا للمركبات المحضرة في المختبر ضد نوعين من البكتريا الموجبة
... Show MoreThe main topic of this study is central around the independence of Jordanian central bank and the extent of the effectiveness at the bank in leading the monetary policy without interferences or pressures from side of the government. the degree of independence of Jordanian central bank was based on the following based hypothesis following ,there is relationship between the independence of the central bank and the legislative and economical indices. the most important recommendations are degree of independence of the Jordan central bank 43.5% is a good one, but it possible to reach a higher degree than this one by to making some modification on the Jordanian central bank law and by the central bank should be more rigid
... Show MoreContracting cancer typically induces a state of terror among the individuals who are affected. Exploring how chemotherapy and anxiety work together to affect the speed at which cancer cells multiply and the immune system’s response model is necessary to come up with ways to stop the spread of cancer. This paper proposes a mathematical model to investigate the impact of psychological scare and chemotherapy on the interaction of cancer and immunity. The proposed model is accurately described. The focus of the model’s dynamic analysis is to identify the potential equilibrium locations. According to the analysis, it is possible to establish three equilibrium positions. The stability analysis reveals that all equilibrium points consi
... Show MoreThe world faced many communication challenges in 2020 after the Covid-19 pandemic, the most important of which was the continuation of schooling. Therefore, the research aimed to analyze the current reality of the studied universities in terms of strengths and weaknesses and measure the implementing level of quality requirements of e-learning. This research studies the impact of knowledge sharing in its dimensions (behavior, organizational culture, work teams, and technology) on the e-learning quality and its dimensions (e-learning management, educational content, evaluation ,and evaluation). After conducting the survey, there was a difference in the universities’ application of the quality requirements of e-learning, as the study
... Show MoreThe current research aims to identify the most important green productivity tools GPT and the possibility of applied in industrial companies in general and the companies operating in the province of Nineveh, in particular, as well as the study of some personality characteristics and functional, which is believed to be an impact on the application of these tools in industrial companies. Accordingly, the research community of managers in the company of medicines and medical supplies ready-made clothes _ operating in the province of Nineveh, who are (80) while the manager was subjected to research procedures (49) Director representing (61.25%)
... Show MoreThis study confirms the ubiquitin conjugating enzyme 2B (Rad6) plays a significant role in the DNA repair pathway also because the ubiquitin-conjugating pathway. The DNA repair pathway could be a variety of bypass repair mechanism where the broken base pair is bypassed by permitting the replication fork to labor under the site of injury. This is often done by a shift mechanism wherever deoxyribonucleic acid enzyme - δ is switched with DNA enzyme - η (DNAP - η). Site of DNAP - η is massive enough to permit the broken ester to labor under, and so bypass the broken nucleotide. However, this is often potential solely through the involvement of Proliferating cell nuclear antigen (PCNA) that could be a processivity issue and it acts as a plat
... Show MoreMass transfer has been studied at rotating cylinder electrodes fabricated with spiral-wound woven-wire meshes using reduction of copper as a test reaction. The experimental data were correlated by an empirical expression between the Sherwood number and the Reynolds number, both regarding the hydraulic diameter as a characteristic length. It was found that the Sherwood number was dependent upon the Reynolds number to the power of 0.521. An enhancement factor was adopted to compare the efficiency of the new rotating cylinder electrode with previous three-dimensional rotating cylinder electrodes. The results showed that the new type has a mass-transfer enhancement factor 2.3 times higher than those obtained with smooth rotating cylinder electr
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