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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
Many researchers tried to prevent or reduce moisture damage and its sensitivity to temperature to improving the performance of hot mix asphalt because it is decreasing the functional and structural life of fixable pavement due to the moisture damage had exposed to it.
The main objective of this study is to inspect the effect of (fly ash “3%, 6%, 12%”, hydrated lime”5%, 10%, 20%” and silica fumes”1%, 2%, 4%) referring to previous research by the net weight asphalt cement as a modified material on the moisture and temperature sensitivity of hot mix asphalt. This was done using asphalt from AL-Nasiria refinery with penetration grade 40-50, nominal maximum size (12.5) mm (surface course) of aggregate and on
... Show MoreBackground: Cigarette smoking (CS) is a periodontal disease risk factor, affecting clinical parameters such as bleeding on probing (BOP), plaque index (PI), gingival index (GI) and proinflammatory cytokines level. This study examines the impact electronic cigarette use on proinflammatory cytokines and periodontal parameters. Methods: In this non-randomized study, ninety participants diagnosed with gingivitis were assigned into three groups. examined the effect of oral hygiene instructions on periodontal parameters and inflammatory biomarkers. Thirty CS (n=30) vaping electronic-cigarettes (e-cig) (n=29), and non-smoker (NS) (n=31) was included. Clinical parameters including PI, BOP, and GI were recorded at baseline and after 3 weeks
... Show MoreConsistent "with the thought of tax talk is unified tax natural evolution for him, as the application leads to the inclusion of tax all branches of income and its sources and through truncated part of this entry through the application of price ascending it, it means the procedures of tax reform. Taxes on total income characterized by giving a clear picture of the total income of the taxpayer and its financial situation and its burden family which allows granting exemptions, downloads, and application of prices that fit this case. This requires reconsideration of the structure of the tax system in force and the transition from a system specific taxes to the tax system on the total income of the integration of income from the rental of re
... Show MoreHusbands’ violence towards their wives is one of the greatly important issues in social sciences. Accordingly, the current study aims at determining the levels of violence practiced by husbands towards their wives to propose a professional program from the perspective of the general practice of social work to overcome such a phenomenon. The study is descriptive in nature, where the researcher has used a comprehensive social survey method. To achieve the goal of the study, the researcher has prepared a questionnaire that consisted of two parts. The first part contains the primary data of the two sections, and the second contains (38) phrases distributed over four axes to measure the levels and types of violence among the sample’s memb
... Show MoreThe Hopfield network is one of the easiest types, and its architecture is such that each neuron in the network connects to the other, thus called a fully connected neural network. In addition, this type is considered auto-associative memory, because the network returns the pattern immediately upon recognition, this network has many limitations, including memory capacity, discrepancy, orthogonally between patterns, weight symmetry, and local minimum. This paper proposes a new strategy for designing Hopfield based on XOR operation; A new strategy is proposed to solve these limitations by suggesting a new algorithm in the Hopfield network design, this strategy will increase the performance of Hopfield by modifying the architecture of t
... Show MoreA method has been demonstrated to synthesise effective zeolite membranes from existing crystals without a hydrothermal synthesis step.
It sheds light on the cultural dimension in the decentralized administration experience in Iraq as evaluation tool by adding a new dimension in studying decentralization in addition to the administrative, political and legal dimensions .The proposal of study is that without the civil political culture ,the administrative decentralization in Iraq which remains weak and it may be imposed to a set of problems. - The study includes an introduction, conclusion and a set of political and cultural issues , its components and it may have the political analysis of this culture and its role in determining the movement of the administrative decentralized movement in Iraq post 2003.