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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
We have studied in this research litter (Taa) a morphological , sonic indicative and comparative study among four Semitic languages. They are Arabic , Hebrew, Syriac and Akkadian languages . We have divided the research into a number of pivots beginning with an entrance about the letter (Taa) in Semitic languages and the symbols which are used by these languages referring to . Then we have studied (Taa) from sonic side with letters phenomenon (b, g, k, p, t) the six in both Hebrew and Syriac languages . The letter (Taa) is formed one of them and the sonic change that is happening in articulation (Taa) according to sonic rules related to these letters in case of emphasis or in case of neglected (not emphasis). Then we have studied the pro
... Show MoreThe current research aims to provide a conceptual and applied frame on the subject of multi- level analysis in the research of business administration. The research tries to address some of the problems that befall the preparation of research and studies at the Arab level and local level, where the unity of theory and measurement and analysis, as well as clarify the various types of conceptual constructs and give researchers the ability to distinguish different models related to the level of analysis. On the other hand, this research provides an example of
... Show MoreThe paper deals with claims in construction projects in Iraq and studies their types, causes, impacts, resolution methods and then proposes a management system to control the impacts of claims. Two parts have been done to achieve the research objective (theoretical part and practical part). The findings showed that the main types of the claims are extra work claims, different site condition claims, delay claims and the main causes of the claims are variation of the orders, design errors and omission, delay in payments by owner, variation in quantities and scheduling errors. The claims have bad impacts on the cost by increasing (10% to 25%) and also on the duration of the project by increasing from (25% to 50%).The negotiation is the main
... Show MoreIn this research, a factorial experiment (4*4) was studied, applied in a completely random block design, with a size of observations, where the design of experiments is used to study the effect of transactions on experimental units and thus obtain data representing experiment observations that The difference in the application of these transactions under different environmental and experimental conditions It causes noise that affects the observation value and thus an increase in the mean square error of the experiment, and to reduce this noise, multiple wavelet reduction was used as a filter for the observations by suggesting an improved threshold that takes into account the different transformation levels based on the logarithm of the b
... Show MoreThe study of the dynamic behavior of packed distillation column was studied by frequency response analysis using Matlab program. A packed distillation column (80 mm diameter) (2000 mm height) filled with glass packing (Raschig Rings 10mm), packing height (1500 mm) has been modified for separation of methanol-water mixture (60 vol%). The column dynamic behavior was studied experimentally under different step changes in, feed rate (±30%), reflux rate (±22%), and reboiler heat duty (±150%), the top and bottom concentration of methanol were measured. A frequency response analysis for the above step response was carried out using Bode diagram, the log modulus and the phase angle were used to analyze the process model. A Matlab progra
... Show More......
The Iraqi government seeks to overcome the financial crisis by investing and privatizing some projects to achieve sustainable growth. Most of the investment projects in Iraq suffer from many constraints that greatly impact the success of these projects. A survey of the opinions of a group of experts was conducted to identify the most important constraints facing the investment process in Iraq. Then the experts' answers were arranged in a closed questionnaire and distributed to the research sample for which the statistical analysis was conducted. Through it, the most important (17) factors that had the greatest impact on the failure of investment projects in Iraq were reached. One of the main constraints was
... Show MoreObjective: To assess prospectively functional outcome of interlocked intramedullary nailing fixation in management of closed tibia shaft fractures. Methodology: This prospective study included 134 patients with closed shaft tibia fractures with age 18-60 years and isolated closed fracture of shaft of tibia. The fractures were fixed by interlocking intramedullary nail. At follow-up after 12 months postoperatively, the functional outcome was assessed radiographically for the sign of union and clinically according to Klemm-Borner criteria. Results: The mean age was 38.55 years. Out of 134 patients, 55.2% were male. The cause was road traffic accident in 44.8%, majority of the fracture occur in the mid-shaft (41.8%), and oblique fracture was th
... Show MoreThe purpose of this research is to identify the youth issues in Talk Shows in the Iraqi satellite channels via monitoring a sample of episodes of the Talk Shows episodes which are concerned and analyzed the youth issues in the Iraqi satellite channels, namely, «Hala Shabab Program» at Al-Iraqia satellite Channel and «Shabab wa Banat Program» at Al-Sumaria satellite Channel by recording and re-watching them again. This research is classified as one of descriptive researches. The survey method was adopted in this study.
For this purpose, the researcher prepared an analysis form. The researcher de
... Show MoreABSTRACT Background: Color changes that are detectable to human eye can affect the esthetic appearance of ceramic veneers. The purpose of this study was to evaluate and compare the effect of artificial accelerated aging on the color of ceramic veneers cemented with different resin cements. Materials and Methods: Sixty discs were prepared with 0.5 mm thickness, 30 discs made from IPS e.max press (Ivoclar Vivadent) and 30 discs were made from VITA Enamic (VITA Zahnfabrik). The discs were cemented with three resin cements: Variolink Veneer MV 0 shade (Ivoclar Vivadent), Rely X veneer Translucent shade (3M ESPE) and NX3 Nexus Clear shade (Kerr Corporation) with 0.1 mm thickness. The spectrophotometer Easyshade Advance was used to measure the co
... Show MoreDeveloped and underdevelopment countries, on equal terms, face the problem of budget deficiency. Budget deficiency means that the public expenditure surpasses the public revenues. This, on the international level, is one of the most serious economic problems with many direct effects on the national economy, and depends, basically, on its finance chosen method. Looking for a solution to this problem, for this reason and many other ones, has been highlighted in spite of the many attempts to reduce the role of the governmental expenditure. Budget deficiency can not be attributed to a single unique cause since it is complex phenomenons the causes of which are related to many factors contribute to its occurrence, some of which refer t
... Show More