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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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 applications of mobile robots in rescue scenarios, surviving to search, and exploration for outdoor navigation have received increasing attention due to their promising prospects. In this paper, a simulation of a differential wheeled mobile robot was presented, implementing a Global Positioning System (GPS) data points to specified starting points, final destination, and total error.
In this work, a simple kinematic controller for polar coordinate trajectory tracking is developed. The tracking between two points, pose to pose, was specified by using the GPS data points. After that, the geodesy (GEO) formulation was used to convert the geodesy coordinate to Euclidean or polar coordinate. The Haversine equation
... Show MorePre-eclampsia is the most common medical complication of pregnancy associated with increased maternal and infant mortality and morbidity. Its exact etiology is not known, although several evidences indicate that various elements might play an important role in pre-eclampsia. This study was carried out to analyze and to compare the concentration of calcium, in mild pre-eclampsia and in normal pregnant women , and to determine the effect of oral supplementation with calcium on mild pre-eclampsia , and whether this effect is related to the change in the level of serum calcium. Forty- five women in the third trimester of pregnancy were selected to participate in this study and divided into: fifteen apparently healthy, normo
... Show MoreSand production in unconsolidated reservoirs has become a cause of concern for production engineers. Issues with sand production include increased wellbore instability and surface subsidence, plugging of production liners, and potential damage to surface facilities. A field case in southeast Iraq was conducted to predict the critical drawdown pressures (CDDP) at which the well can produce without sanding. A stress and sanding onset models were developed for Zubair reservoir. The results show that sanding risk occurs when rock strength is less than 7,250 psi, and the ratio of shear modulus to the bulk compressibility is less than 0.8 1012 psi2. As the rock strength is increased, the sand free drawdown and depletion becomes larger. The CDDP
... Show MoreThis paper investigates the experimental response of composite reinforced concrete with GFRP and steel I-sections under limited cycles of repeated load. The practical work included testing four beams. A reference beam, two composite beams with pultruded GFRP I-sections, and a composite beam with a steel I-beam were subjected to repeated loading. The repeated loading test started by loading gradually up to a maximum of 75% of the ultimate static failure load for five loading and unloading cycles. After that, the specimens were reloaded gradually until failure. All test specimens were tested under a three-point load. Experimental results showed that the ductility index increased for the composite beams relative to the refe
... Show MoreThe figure of personality modes determines its privileged style in the use of modern and advanced technological tools in the process of changing and developing in order to keep up with that. The proses of selection and choosing administrators in the appropriate places are the most important functions of senior management because it is easy to adopt factory buildings or establishments But this is a human world as that of machines world. So it is required to have people in the process of changing those who have a time, Knowledge, skill, ability and strong administrative personal skills, those people (leaders) should to put a clear vision for the selection and application of the change efforts and to create the necessary climate and
... Show MoreThis paper discusses the role of Auditors' Technological Maturity in reinforcing the quality of auditing profession, through focusing on the concepts of Technological Maturity and quality of auditing profession, as well as designing a proposed model for Technological Maturity which includes five evolutionary and sequential stages, and this proposed model would contribute to reinforce the quality of auditing. This proposed model will be employed in the field of auditing profession because the importance of the development and investment in this profession and the importance of the need for specialized knowledge in Information Technology, and the result of a proposed model is development of technological knowledge for the auditor to reach
... Show MoreThis study aims to examine the technologies of education and their importance, shedding light on their reality and status in Sudan especially in the secondary stage. It has become necessary to invest these technologies and include them in different aspects of the technical education curricula. Such a step helps cope with the innovative scientific development in the advanced countries, qualify professors and technicians, develop the factories and workshops, and create an attractive technical educational environment to the pupils. Thus, the researcher has adopted a descriptive analytical approach that is based on conducting pilot visits to certain technical schools in Al-Khartoum state. Different aspects of such schools were examined
... Show MoreBased on the theoretical ideas of E. Cassirer, a methodology is developed and an analysis of the painting work by J. Saleem, a representative of modern Iraqi painting, is carried out. While comparing the artistic programme of J. Saleem and the views of E. Cassirer, the methodological potential of the theory of the symbol for the art criticism analysis of the regional painting is clarified. Comparative analysis with the inclusion of the works of B. Buffet, B. Turetsky, J. Miro helps to see the multiple meanings of the same cultural symbol in thematically similar works of different years, created in different socio-cultural circumstances. The article shows that for regions with a shorter history (France, Russia, Spain, etc.), which have lo
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