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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
The effect of linear thermal stratification in stable stationary ambient fluid on free convective flow of a viscous incompressible fluid along a plane wall is numerically investigated in the present work. The governing equations of continuity, momentum and energy are solved numerically using finite difference method with Alternating Direct implicit Scheme. The velocity, temperature distributions
and the Nusselt number are discussed numerically for various values of physical parameters and presented through graphs. ANSYS program also used to solve the problem. The results show that the effect of stratification parameter is marginalized with the increase in Prandtl number, and the increase in Grashof number does not practically vary the
The article approaches the characteristics of Russian literature in the time of Khrushchev or the "thaw" period a very short period of Soviet history, characterized by the easing of the dictatorship of power and relaxation in various areas of people's lives. The interest in the research is focused on the importance of interpreting the family portrait in a short but distinct period in the development of Russian/Soviet literature. The research material is the story of Sholokhov's “The Fate of Man” 1956, the story of Panova “Serioga” 1955, and Abramov’s story “Fatherless” 1961. В статье рассматриваются особенности художественной литературы периода хруще
... Show Moreيعتقد البعض ان مفهوم العلم يعني الآلات والاجهزة العلمية (تقنيات التعليم) وهي لا تختلف عن مفهوم تكنولوجيا المعلومات , ويعد هذا الاعتقاد خاطئ , لان العلم هو بناء المعرفة العلمية المنظمة والتي يتم التوصل اليها عن طريق البحث العلمي , اما تكنولوجيا المعلومات فهي "التطبيقات العملية للمعرفة العلمية في مختلف المجالات ذات الفائدة المباشرة بحياة الانسان, او هي النواحي التطبيقية للعلم وما يرتبط بها من آلات واجهزة".
The audit profession today gets an increasing interest by the financial , economic and legal contemporary societies , because of the importance of the technical & neutral auditor’s opinion to the financial reports beneficiaries in order to enable them making their investment decisions , but some of them whom suffered damage or loss when they made that decisions according to the mentioned financial statements which consolidated with auditor’s report , exposed the function to a responsibility and credibility crisis in addition to missing the trust especially at the latest years. They always ask why or what is the reason that cause the auditor didn’t giving us any warning signs about the economic mater for that companies.
The Accounting Disclosure for non-current intangible assets is necessary to rely on accounting information by decision makers in the economic unity, two international accounting standards issued (IAS16,36), which aims to provide the foundations of the recognition, measurement and disclosure of appropriate assets Non-current tangible. (IAS16) allowed to use re-evaluation approach to measure assets entrance due to the inadequacy of the accounting information resulting from the application of the historical cost of the entrance under increasing technical developments and continuing that leave clear their effects on non-current intangible assets, As well as the requirements of what came (IAS36) the importance of accounting for the impairment
... Show MoreThe contractual imbalance is perceived today by the majority of the doctrine as being one of the pitfalls to the execution of the contracts. As a result, most legislations grant judges the power to intervene to restore it. Granting the judge the power to complete the contract raises the question of the extent to which the judge can obtain such power. Is it an absolute authority that is not limited? If so, is it a broad discretion in which the judge operates in his conscience, or is it a power of limited scope by specific legal texts and conventions? This is what we will try to answer in this research.
Systems on Chips (SoCs) architecture complexity is result of integrating a large numbers of cores in a single chip. The approaches should address the systems particular challenges such as reliability, performance, and power constraints. Monitoring became a necessary part for testing, debugging and performance evaluations of SoCs at run time, as On-chip monitoring is employed to provide environmental information, such as temperature, voltage, and error data. Real-time system validation is done by exploiting the monitoring to determine the proper operation of a system within the designed parameters. The paper explains the common monitoring operations in SoCs, showing the functionality of thermal, voltage and soft error monitors. The different
... Show MoreA general velocity profile for a laminar flow over a flat plate with zero incidence is obtained by employing a new boundary condition to the other available boundary conditions. The general velocity profile is mathematically simple and nearest to the exact solution. Also other related values, boundary layer thickness, displacement thickness, momentum thickness and coefficient of friction are nearest to the exact solution compared with other corresponding values for other researchers.