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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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 research is summarized in the construction of a mathematical model using the most common methods in the science of Operations Research, which are the models of transportation and linear programming to find the best solution to the problem of the high cost of hajj in Iraq, and this is done by reaching the optimum number of pilgrims traveling through both land ports and the number Ideal for passengers traveling through airports by Iraqi Airways, instead of relying on the personal experience of the decision-maker in Hajj and Umrah Authority by identifying the best port for pilgrim's travel, which can tolerate right or wrong, has been based on scientific methods of Operations Research, the researcher built two mathematical models
... Show MorePurpose – The main purpose of this research is to highlight the main role of strategic leadership skills for top managements in accessing to effective management in accordance with the (VUCA Prime) methodology in (VUCA) environment as Miniature virtual environment, which refers to (Volatility), (Uncertainty), (Complexity), and (Ambiguity).
methodology – To achieve the research objective, this study selected the quantitative approach in research design, Questionnaire was used as the main instrument for data collection, the sample comprised the opinion poll (106) individual who functions as a head department. (Structural equation modelling by (Smart Pls3)
... Show MoreExtreme conditions will cause the water level of high fill canal segment to change suddenly, which will affect the velocity and pore pressure of the slope. A 9 km irrigation earth canal in the city of Alsyahy, 15 km away from Al-Hilla city, and branching off from the left side of Shatt Al-Hilla at 57 km, was studied. The aim of this work is to study and analyze the effect of rationing system on the Birmana earthen canal during rapid drawdown case. Finite element modeling with Geo-Studio software was used in the present study to analyze the combined seepage and slope stability for three cycles. The resulting minimum safety factor obtained from the analysis using the saturated and
: Cervical malignancy positioned as the fourth most prevalent disease among women around the world. HPVs especially HPV16 are the causative agent of cervical cancer, responsible of about 5% of all human cancers worldwide. Some researchers found that the fibronectin is repressed by the papillomavirus (HPV) type 16 E7 oncoprotein in both HPV-positive nontumorigenic and tumorigenic cell lines, while others found that the HPV oncoprotein increase the levels of fibronectin. The aim is to study the effect of HPV infection on Fibronectin expression and their correlation onthe development of Cervicalcancinoma. The current retrospective study enrolled paraffinized blocks of two groups. The research included 30 cervical carcinomatous tissues as well
... Show MoreThis research is seeks to state the role of Green Human Resources Management Practices and their dimensions (Green Employment and Selection, Green Performance Assessment, Green Training & Development and Green Compensation and Stimulation Systems) in strengthening the Strategic Positioning in the Nongovernmental Hospitals in Erbil city, and aims to analyze the relationship between Green Human Resources Management Practices and Strategic Positioning and to show the impact of Green Human Resources Management Practices in determining the Strategic Position.
It is depended on a questionnaire as key tools for achieving data, as designed on
... Show MoreDisabled people are among the most important groups that need attention, care, and financial and moral care. They cannot fulfill the requirement of life normally without care from a person to meet their special needs. The disability is either mental or physical. The Iraqi government has paid attention to this category by adopting a law for this category, represented by Law No. (38) for the year (2013), which keeps their rights and duties in Iraqi society by establishing institution of persons with disabilities and special needs of the Ministry of Labor and Social Affairs to create a modern society politically, socially, culturally or economically. In view of the importance of this group in society, the media reinforces the communit
... Show MoreEvolution has become a feature of this era because of the speed that makes it open multiple horizons and many to identify everything that is new in different areas and also characterized by the competitive position of emotional attitudes changing depending on the positions of winning and defeat, and the use of training methods are the most important pillars of the game of wrestling, The methods contribute to raising the level of the wrestler and refining his physical and skill potential. The problem of the research is that the shooting exercises from above the chest are very important in Roman wrestling and can be terminated by the player. Through very personal interviews for coaches and concluded that there is a weakness in the level of fl
... Show MoreAbstract:
This research aims to compare Bayesian Method and Full Maximum Likelihood to estimate hierarchical Poisson regression model.
The comparison was done by simulation using different sample sizes (n = 30, 60, 120) and different Frequencies (r = 1000, 5000) for the experiments as was the adoption of the Mean Square Error to compare the preference estimation methods and then choose the best way to appreciate model and concluded that hierarchical Poisson regression model that has been appreciated Full Maximum Likelihood Full Maximum Likelihood with sample size (n = 30) is the best to represent the maternal mortality data after it has been reliance value param
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