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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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 seeks to try to address one of the important issues in society that prevents the state from achieving its social, economic, political and financial goals, represented by the low tax proceeds, through which it can achieve those goals. What is reflected on the tax proceeds, knowing that the General Tax Authority does not take into account the issue of analyzing the opportunity cost of corporate capital as one of the profit indicators when setting the annual controls, which leads to a decrease in the tax proceeds, and therefore the research objective will be to shed light on the importance of adopting the concept of analysis The opportunity cost by the General Tax Authority to achieve a tax proceeds commensurate with t
... Show MoreThe posterior regions of the jaws usually represent a significant risk for implant surgery. A non-valid assessment of the available bone height may lead to either perforation of the maxillary sinus floor or encroachment of the inferior alveolar nerve and consequently to implant failure. This study aimed to evaluate the reliability of surgeon’s decision in appraising the appropriate implant length, in respect to vital anatomical structures, using panoramic radiographs.
Only implants that are inserted in relation to the maxillary sinus (MS) or the mandibular canal (MC) were enrolled
Pore pressure means the pressure of the fluid filling the pore space of formations. When pore pressure is higher than hydrostatic pressure, it is named abnormal pore pressure or overpressure. When abnormal pressure occurred leads to many severe problems such as well kick, blowout during the drilling, then, prediction of this pressure is crucially essential to reduce cost and to avoid drilling problems that happened during drilling when this pressure occurred. The purpose of this paper is the determination of pore pressure in all layers, including the three formations (Yamama, Suliay, and Gotnia) in a deep exploration oil well in West Qurna field specifically well no. WQ-15 in the south of Iraq. In this study, a new appro
... Show MoreIn this work, the effect of partial amounts of gases in gas mixture of a CW CO2 laser on the output power was investigated. Also their effect on the condition determining the glow-discharge self-sustaining required for pumping the active medium was studied. Two fit relations were derived to predict the output laser power and the electric field to unit pressure ratio as functions to the partial amounts of gases. Results presented in this work could be used fruitfully to determine some of the optimum operational conditions of glow-discharge low-power CW CO2 lasers.
Carbon nanoparticles are prepared by sonication using carbon black powder. The surface morphology of carbon black (CB) and carbon nanoparticles (CNPs) is investigated using scanning electron microscopy (SEM). The particles size ranges from 100 nm to 400 nm for CB and from 10 nm to 100 nm for CNPs. CNPs and CB are mixed with silicon glue of different ratios of 0.025, 0.2, 0.05, and 0.1 to synthesis films. The optical properties of the prepared films are investigated through reflectance and absorbance analyses. The ratio of 0.05 for CNPs and CB is the best for solar paint because of its higher solar water heater efficiency and is then added to the silicon glue . Temperature of cold water and temperature of hot water in storage tank were ta
... Show MoreIn spite of the disappearing of a clear uniform textbook for teaching ESP at different departments and different colleges in both scientific and humanistic studies, the practitioners at those departments and colleges have to teach translation as one of the important requirements to pass the English language exam. The lack of defined translation activities is a noticeable problem therefore; the problem of teaching translation is diagnosed in that the students lack the ability to comprehend the text in English language and other translation knowledge and skills.
The study aims to suggest a translation strategy and then find out the effect of the translation strategy on ESP learners’ achievement in translation. A sample of 50 stud
... Show MoreThree types of zeolite A were prepared from Iraqi kaoline which are 3A, 4A and 5A by ion exchange method .They were characterized by XRD and atomic absorption techniques .They were used as adsorbents to examine their applicability for H2S adsorption .The adsorption process was performed in a static form and constant volume system which constructed from stainless steel .The effect of zeolite type and temperature on the adsorption properties of H2S at -5 , 25 and 55 oC was studied .The zeolite type 5A has the highest adsorption value (79.384 µmol/g ) and the three types may be arranged in a sequence toward H2S adsorption as 5 A> 4A>3A .The amount of H2S adsorbed increased as temperature decreased from 55 to -5 for all samples. Langmuir , Fre
... Show MoreThe impact of management control systems (MCS) on organizations performance empirical research has been the subject of numerous studies during the past decade in developed and emerging economies. In the contemporary competitive, complex and changing global business environment, firms are being challenged to adopt business models that enable them to address the strategic uncertainties and risks they face in their business environments. The main issue of this study is that management accounting researchers argue that one of the ways firms can continually rejuvenate themselves to survive and succeed in these complex and uncertain environments is to understand the role of management control systems in Formulating a b
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