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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
In this paper all possible regressions procedure as well as stepwise regression procedure were applied to select the best regression equation that explain the effect of human capital represented by different levels of human cadres on the productivity of the processing industries sector in Iraq by employing the data of a time series consisting of 21 years period. The statistical program SPSS was used to perform the required calculations.
The research was performed in order to investigate the prevalence of Eimeria spp in buffalo. Coccidiosis, is a common livestock disease include water buffaloes and nothing is known about the most pathogenic species of Eimeria. Since the highest prevalence of oocyst shedding and incidence of disease occurs in buffalo calves less than one year of age. The omnipresent occurrence and negative effects of the infection on health and buffalo growth output are taken into account. Therefore, both farmers and veterinarians should pay greater attention to infections with Eimeria spp. And there is little analysis of data reported in Iraq and the world regarding Eimeria infection in river buffalo spp.
The effect of UV-light on the tensile properties of pure PC has been studied. It was shown that irradiation of PC undergo a drop in the tensile properties of 30 hour of exposure. The results of irradiated samples shows that the addition of ZnO and TiO2 with different percentages (0.5, 1, 1.5 %) will reduce the Young modulus and ultimate stress of PC/ZnO ,PC/ TiO2 composites
The study aimed to prepare a set of qualifying exercises to improve the muscular strength of the muscles surrounding the ankle joint by applying different resistances according to the nature of the movement of this joint, which is one of the second moving joints (flexion, extension and rotation of the right and left) in order to increase the efficiency of all muscles working on this joint according to those movements and identification On the impact of these exercises and assume that there will be statistical differences between the two tests of the research sample. The researcher used the semi-articulated experimental method with a pre- and post-test for one group. The injury was evaluated on the women's national team players durin
... Show MoreThis research introduces a developed analytical method to determine the nominal and maximum tensile stress and investigate the stress concentration factor. The required tooth fillets parametric equations and gears dimensions have been reformulated to take into account the asymmetric fillets radiuses, asymmetric pressure angle, and profile shifting non-standard modifications. An analytical technique has been developed for the determination of tooth weakest section location for standard, asymmetric fillet radiuses, asymmetric pressure angle and profile shifted involute helical and spur gears. Moreover, an analytical equation to evaluate gear tooth-loading angle at any radial distance on the involute profile of spur and hel
... Show MoreWhen searching for an answer to the following question: What are the reasons for the reluctance of female physical education teachers in secondary schools to referee sports competitions according to the variable of years of service? It was found that the research aimed to reveal the differences between the opinions of the research sample of physical education teachers in secondary schools (girls) about refereeing sports competitions according to the variable of years of service. To achieve the research goal, it is assumed that there are significant differences between the average opinions of the research sample of female teachers and their reluctance and the reasons for the differences in the practice of refereeing sports competitions accor
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Statistical control charts are widely used in industry for process and measurement control . in this paper we study the use of markov chain approach in calculating the average run length (ARL) of cumulative sum (Cusum) control chart for defect the shifts in the mean of process , and exponentially weighted moving average (EWMA) control charts for defect the shifts for process mean and , the standard deviation . Also ,we used the EWMA charts based on the logarithm of the sample variance for monitoring a process standard deviation when the observations (products are selected from al_mamun factory ) are identically and independently distributed (iid) from normal distribution in continuous manufacturing .
... Show MoreIn the last years, the self-balancing platform has become one of the most common candidates to use in many applications such as flight, biomedical fields, industry. This paper introduced the simulated model of a proposed self-balancing platform that described the self–balancing attitude in (X-axis, Y-axis, or both axis) under the influence of road disturbance. To simulate the self-balanced platform's performance during the tilt, an integration between Solidworks, Simscape, and Simulink toolboxes in MATLAB was used. The platform's dynamic model was drawn in SolidWorks and exported as a STEP file used in the Simscape Multibody environment. The system is controlled using the proportional-integral-derivative (PID) co
... Show MoreParties as active units in this process in order to work must have access to sources of funding in order to maintain their political presence in society and participate in the process of electoral competition, To win the election, bolstering the huge role that money has played in influencing the principle of equality among contestants in the elections. Those who own money will have a greater chance of winning the elections while less competitive opportunities for others who do not own the money or what they own does not give them the competitive ability to win elections. From this point of view, controlling political finance through legal regulation and institutional, media and popular monitoring has become an important requirement
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