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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
Coronary heart disease (CHD) is the leading cause of death in United State (U.S.). Controlling of modifiable risk factors such as smoking, hypertension (HT), diabetes mellitus (D.M.), dyslipidemia, physical inactivity & obesity will prevent other serious cardiovascular complications
Support vector machines (SVMs) are supervised learning models that analyze data for classification or regression. For classification, SVM is widely used by selecting an optimal hyperplane that separates two classes. SVM has very good accuracy and extremally robust comparing with some other classification methods such as logistics linear regression, random forest, k-nearest neighbor and naïve model. However, working with large datasets can cause many problems such as time-consuming and inefficient results. In this paper, the SVM has been modified by using a stochastic Gradient descent process. The modified method, stochastic gradient descent SVM (SGD-SVM), checked by using two simulation datasets. Since the classification of different ca
... Show MoreStudy of Direct Marketing techniques and determining the scope of the suitability of each of them in the application in the Iraqi market - An analytical and explorative study for sample of views for wholesaler in Baghdad. The essential idea of the research is to go into the most important concepts which have been mentioned in the direct marketing and determining its current and most important techniques and knowing the scope of applying these techniques in Baghdad main markets (Karrada, Jamilah, shorja, Baya area, zeyouna and new Baghdad) and which of those techniques most applicable in these markets. The research took a sample of (100) wholesalers who practice the activities of selling nutritional items, auto and outs spare part
... Show MoreIn this research, the kinetic studies of four isoenzymes of Asprtate aminotransferase, which partially purified from the urine of chronic renal failure patients were carried out .The four isoenzymes were obeyed Michaelis-Menton's equation and the optimum concentration of their substrate (Aspartic acid) was (166.5x10-3) mole/liter,and their Km values were determined. Four isoenzymesI,II,III,IV have shown an optimum pH at 7.4.The four isoenzymes obeyed Arrhenius equation up to 37º C and their Ea and Q10 constants were determined .
Abstract: Microfluidic devices present unique advantages for the development of efficient drug assay and screening. The microfluidic platforms might offer a more rapid and cost-effective alternative. Fluids are confined in devices that have a significant dimension on the micrometer scale. Due to this extreme confinement, the volumes used for drug assays are tiny (milliliters to femtoliters).
In this research, a microfluidic chip consists of micro-channels carved on substrate materials built by using Acrylic (Polymethyl Methacrylate, PMMA) chip was designed using a Carbon Dioxide (CO2) laser machine. The CO2 parameters have influence on the width, depth, roughness of the chip. In order to have regular
... Show MoreA mathematical model constructed to study the combined effects of the concentration and the thermodiffusion on the nanoparticles of a Jeffrey fluid with a magnetic field effect the process of containing waves in a three-dimensional rectangular porous medium canal. Using the HPM to solve the nonlinear and coupled partial differential equations. Numerical results were obtained for temperature distribution, nanoparticles concentration, velocity, pressure rise, pressure gradient, friction force and stream function. Through the graphs, it was found that the velocity of fluid rises with the increase of a mean rate of volume flow and a magnetic parameter, while the velocity goes down with the increasing a Darcy number and lateral walls. Also, t
... Show MoreAn advertisement is a human activity as old as human societies. As it was practiced by each society in accordance with the circumstances of the times and the means of communication available. The evolution of advertisement in the modern era reflected many factors to become an essential part of the lives of individuals in the world. Interesting in television advertising has increased in particular because it is the first and most influential mass media in the minds of people.
Advertisements play a big role in our lives as individuals. As advertisements surround us where we have been found; and bring us many benefits; as well as their contribution to accelerate the process of economic development a
... Show MoreIt included the introduction to the research and its importance, as the knee joint is one of the important joints in the human body that are susceptible to injury, and among these injuries is the roughness of the knee that occurs as a result of weakness and imbalance in the work of the quadriceps muscle, so its treatment is through rehabilitation exercises to treat weakness and gain flexibility and strength.Hence the importance of the research by developing rehabilitation exercises with different resistances in the water medium and restoring flexibility and muscular strength for patients with knee roughness for ages from 30-40 years, and the experimental method was used to solve the research problem, and the research sample included (6) of
... Show MoreObjective: To determine the functional and radiological outcomes of lower third tibia closed fractures fixed by nail or plate osteosynthesis. Methodology: This randomized controlled trial included 20 patients presenting with closed fracture lower third tibia in Al-Kindy teaching hospital, Baghdad, Iraq. The patients were divided as every other one into two equal groups; group I had fractures fixed by 3.5 mm locked plate and group II by intramedullary locking nail. We followed all patients for 24 weeks to assess surgical complications, fracture union, alignment and functional outcome based on Knee society score (KSS). Results: The mean union time in both groups was 10.2 ± 1.48 and 9.3 ± 1.77 weeks, respectively (p = 0.003). Mean KSS in bot
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A research study in which a methodology for quality indicators that can be adopted to evaluate the educational process in educational institutions within a specific strategy helps individuals in charge of educational education to make appropriate decisions based on accurate and properly approved plans to achieve successful outcomes.
These indicators can be used to judge the quality of educational institutions in order to improve, improve and develop them. This study has concluded the necessity of putting quality into actual application in order to benefit from it in evaluating the future action of Iraqi educational institutions.
The external changes brought about by technology and family life have made the
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