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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
Most of the big companies and especially the intillictual ones become a ware of an important fact, and That is, The intillictual capital in new global economy, is a new source for Them & This Valuable source exceed in importance. The other company's sources.
The Traditional disclouser systemes are unable to supply the decisions makers with the Fundimental information require to handel the on going operations which are based on Knowledge and intangible source. But the measuring of this source and the disclose for it in the financial Statements will lead to gain features Statements which will benefit all the parties and lead to make the value of the company great.
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... Show MoreThe current study is aimed to identify personality types of the lecturers of Baghdad University as well as identify the prevailing types among the lecturers. In addition, the study aimed to identify the significant difference among personality types (The Enneagram) according to the variables of academic title and scientific major . One hundred and ninety four lecturers were involved in this study. In order to achieve the study's aims, the scale of (Baron& Wagele 1994) was used to measure the nine personality types (The Enneagram) that was translated by( Anwar Omar Ibrahim 2012). Some statistical analysis were used and the result demonstrated that Romantic types was found to be the most prevailing types among the lecturers of Baghdad
... Show MoreUrban planning task and the control of constructional planning and urban management for cities considers the main tasks that the government takes care off. The paper discusses the concept of power from historical view of ancient Islamic cities to discover the strategies of urban management that the Islamic city adopt and to employ it in contemporary cities ,the more problems that modern cities suffer from which appears through poorness of urban context ,belongs to the loss of balance exists between the different faces of power that takes the tasks of urban management .therefore enhancement of urban environment is being through re-back that balance in administrative structures that make the cities go ahead . So the attention has b
... Show MoreBackground: With the increase in composite material use in posterior teeth, the concerns about the polymerization shrinkage has increased with the concerns about the formation of marginal gaps in the oral cavity environment. New generation of adhesives called universal adhesive have been introduced to the market in order to reduce the technique sensitive bonding procedures to give the advantage of using the bonding system in any etching protocol without compromising the bonding strength. The aim of the study was to study marginal adaptation of two universal adhesives (Single bondâ„¢ Universal and Prime and Bond elect) using 3 etching techniques under thermal cycling aging. Materials and Methods: Forty-eight sound maxillary first premola
... Show MoreThe subject of marketing culture and mental image is one of the important topics in the field of management. There is no study that combines these two variables. The research is important because of the increasing importance of the subject. The future direction of the company in question will support the company's economic and marketing responsibilities. And reflect the company's mental image, as a culture that contributes to changing the reality of the organization investigated by polling the views of a sample of managers in the General Company for Vegetable Oil Industry, which (30) out of the (65) individual, and There are two hypotheses of research: There is a significant
... Show MoreBackground: Relapse of previously moved teeth, is major clinical problem in orthodontics with respect to the goals of successful treatment. This study investigated the effect of orthodontic relapse on the proliferation of fibroblast and epithelial rests of Malassez cells in periodontal ligament of rat molars. Materials and Methods: Sixteen ten-week- old male Wister rats were randomly divided into four groups composed of four animals each: Group I received no orthodontic force (control). In both Group II and Group III, uniform standardized expansive springs were used for moving the maxillary first molars buccally for periods of one and three weeks respectively. The spring initially generated an average expansive force of 20 g on each side.
... Show MoreIn this paper, we introduce an exponential of an operator defined on a Hilbert space H, and we study its properties and find some of properties of T inherited to exponential operator, so we study the spectrum of exponential operator e^T according to the operator T.
This paper aims to investigate the flexural behavior of reinforced concrete beams considering fire resistance by adding Lightweight Expanded Clay Aggregates (LECA) to the concrete mix as partial coarse aggregate replacement. LECA is a type of porous clay with a uniform pore structure with fine, closed cells and hard, tightly sintered skin. The experimental work comprised four reinforced self-compacted concrete beams. All the specimens were identical in their geometrical layout of 1600×240×200 mm, reinforcement details, and support condition (simply supported). For all the beams, the main reinforcement was provided by two bars, each having a diameter of 12 mm, while a bar of 6 mm diameter was employed for the top and shear reinforc
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