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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
Evolution in the modern era Which led to the rapid change in the forms of industrial products For many reasons, So put current research into question the view (What are the design requirements that define the formal change in the Iron clothes)? To reach the aim of In the design cornerstonesUnderlying the formal changethe Iron of the clothes, In the first section shed light on the development stages of systems design lists the historic stages of development and energy operator devices irons and mechanism of action and internal components, while in the second part, which was entitled (The role of technology and the factors influencing the change formality of Iron) touched on the three topics which technology modern industrial and receiver,
... Show MoreThe time series of statistical methods mission followed in this area analysis method, Figuring certain displayed on a certain period of time and analysis we can identify the pattern and the factors affecting them and use them to predict the future of the phenomenon of values, which helps to develop a way of predicting the development of the economic development of sound
The research aims to select the best model to predict the number of infections with hepatitis Alvairose models using Box - Jenkins non-seasonal forecasting in the future.
Data were collected from the Ministry of Health / Department of Health Statistics for the period (from January 2009 until December 2013) was used
... Show MoreIn this research, the problem of ambiguity of the data for the project of establishing the typical reform complex in Basrah Governorate was eliminated. The blurry of the data represented by the time and cost of the activities was eliminated by using the Ranking function and converting them into normal numbers. Scheduling and managing the Project in the Critical Pathway (CPM) method to find the project completion time in normal conditions in the presence of non-traditional relationships between the activities and the existence of the lead and lag periods. The MS Project was used to find the critical path. The results showed that the project completion time (1309.5) dinars and the total cost has reached (33113017769) dinars and the
... Show MoreProsthetic is an artificial tool that replaces a member of the human frame that is absent because of ailment, damage, or distortion. The current research activities in Iraq draw interest to the upper limb discipline because of the growth in the number of amputees. Thus, it becomes necessary to increase researches in this subject to help in reducing the struggling patients. This paper describes the design and development of a prosthesis for people able and wear them from persons who have amputation in the hands. This design is composed of a hand with five fingers moving by means of a gearbox ism mechanism. The design of this artificial hand has 5 degrees of freedom. This artificial hand works based on the principle of &n
... Show MoreIn this study, vegetable tanned leather waste of cow (VTLW-C) is used as adsorbent for removing methyl violet 10B dye from aqueous solution. The VTLW-C adsorbent was characterized by FTIR and SEM in order to evaluate its surface properties before using in adsorption experiments. Batch adsorption method was applied to study the effect of different factors such as weight of leather waste, time of shaking, and starting concentration of methyl violet 10B dye. Different isothermal models such as Langmuir, Freundlich, Temkin and Dubinin-Radushkevich (D–R) were used to analyze the experimental data. Kinetic study proceeds using (PFO) kinetic model and (PSO) kinetic model. The results showed better agreement with the Freundlich model; this means
... Show MoreThe use of Near-Surface Mounted (NSM) Carbon-Fiber-Reinforced Polymer (CFRP) strips is an efficient technology for increasing flexural and shear strength or for repairing damaged Reinforced Concrete (RC) members. This strengthening method is a promising technology. However, the thin layer of concrete covering the NSM-CFRP strips is not adequate to resist heat effect when directly exposed to a fire or at a high temperature. There is clear evidence that the strength and stiffness of CFRPs severely deteriorate at high temperatures. Therefore, in terms of fire resistance, the NSM technique has a significant defect. Thus, it is very important to develop a set of efficient fire protection systems to overcome these disadvantages. This pape
... Show MoreBackground: The present study aimed to assess the distribution, prevalence, severity of malocclusion in Baghdad governorate in relation to gender and residency Materials and Methods: A multi-stage stratified sampling technique was used in this investigation to make the sample a representative of target population. The sample consisted of 2700 (1349 males and 1351 females) intermediate school students aged 13 years representing 3% of the total target population. A questionnaire was used to determine the perception of occlusion and orthodontic treatment demand of the students and the assessment procedures for occlusal features by direct intraoral measurement using veriner and an instrument to measure the rotated and displaced teeth. Results a
... Show MoreThe public budget is regarded a main tool for economic and social development. The preparation of the public budget constitute an important stream which enriches the developmental efforts and the definition of its priorities, therefore it is the focus point of many specializations. The public budget has numerous functions. It is a means to precise and to execute the political and economic goals of the executive authority, a mirror of the economic structure which reflects its strength and weakness points, specifies its revenues and others. Since the parliament is the voice of the society which expresses its interests, then, it must monitor the performance of the government so that the participation of the legislative authority in
... Show MoreThis study aimed at investigating the level of social skills and its relationship with self-regulation among gifted students according to the academic stage and gender. The sample consisted of (417) male and female students at King Abdullah II School for Excellence in Salt, Jordan. Two instruments were used to collect the data; A scale of social skills and a scale of self-regulation. The results revealed that the level of social skills was high among gifted students. There were statistically significant differences in the social skills among gifted students according to their academic stage in favor of the secondary stage and according to their gender in favor of female students. There were statistically signific
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