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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
The research aimed at studying the inhibitive effect of the hot watery dry and ethanolic ginger(85%) and fragrant oil which are added in concentrates of o.o25, o.o5o and 0.1g / 100g respectively in the growth of bacteria and molds. The results of the initial chemical diagnosis showed containment of ginger roots extract on. Alkaloids, Glycosides, Flavonoids and Suponins. The highest inhibitive effect of the bacteria reached the concentrate . 0.1% of the oil extract then the concentrate 0.050% of the ethanolic hot extract follows it. While 0.1% was the least inhibitive concentrate for the hot watery extract. But the inhibitive effect of the hot oily and alcoholic extracts in the numbers of molds colonies was 0.025%, when the concentra
... Show MoreThe research aimed at studying the inhibitive effect of the hot watery dry and ethanolic ginger(85%) and fragrant oil which are added in concentrates of o.o25, o.o5o and 0.1g / 100g respectively in the growth of bacteria and molds. The results of the initial chemical diagnosis showed containment of ginger roots extract on. Alkaloids, Glycosides, Flavonoids and Suponins. The highest inhibitive effect of the bacteria reached the concentrate . 0.1% of the oil extract then the concentrate 0.050% of the ethanolic hot extract follows it. While 0.1% was the least inhibitive concentrate for the hot watery extract. But the inhibitive effect of the hot oily and alcoholic extracts in the numbers of molds colonies was 0.025%, when the concentrate 0.1%
... Show MoreWe need to know the basic facts concerning planning top and bottom limits including any critical levels or the threshold over which the cost would be much higher for land development. Therefore this paper concerned with Baghdad Municipality decision No.2/1004 dated 7/12/2004. The reason behind this decision is the hope to face up at least in the severe housing crisis in the city of Baghdad. This paper attempts to know the attitude of the local community in the general through a field study of people living near such dwelling where third floors are added of. This might indicate any positive or negative effects whether on short or long-term including its effect on the theoretical side including the population growth of Baghdad, the
... Show MoreThe research to knows some biomechanics variables in different spots with and without players in basketball youth players and analysis by using destructive method in surfing study and the research were applied for jump shoot from one of basketball players in ( middle , left , right ) in side zone and out of zone also from three point shoot with and without defense and we depend on successful shoot on analyze .The results and conclusions that center of weight of the player on standby on high and knee angel and hips were more wide also the two angle of wrist , elbow on start of shooting be more wide with defender more than without defender .the maximum high center of weight and shooting angle and ball entrance being less degree with defender
... Show MoreIn this paper, the researcher suggested using the Genetic algorithm method to estimate the parameters of the Wiener degradation process, where it is based on the Wiener process in order to estimate the reliability of high-efficiency products, due to the difficulty of estimating the reliability of them using traditional techniques that depend only on the failure times of products. Monte Carlo simulation has been applied for the purpose of proving the efficiency of the proposed method in estimating parameters; it was compared with the method of the maximum likelihood estimation. The results were that the Genetic algorithm method is the best based on the AMSE comparison criterion, then the reliab
... Show MorePurpose: clarify the integrative relationship of strategic leadership skills and effective management and the role of those skills combined or individually in achieving effective management.
Research design: The researchers used the quantitative method by surveying a class sample from the heads of the executive departments in a group of Iraqi private banks, consisting of (106) individuals according to the (VUCA Prime) methodology for effective management and the ten skills model for Johansen. The questionnaire was analyzed using a model of the structural equation.
Findings: The most prominent results of the research were the presence of a weak ro
... Show MoreThe researchers believe the problem of searching the scarcity or limited tests of time kinetic response led to scarcity or limited availability of experimental research in exercises codified within the training curriculum for the junior class, and therefore has been weakening this physical variable as an important episode in the development of the players physical capacities as well as the lack of measure for this variable within the defensive skills in general and the skill of the player movement defender in particular, and it represents the goal of research in the treatment of the above through the construction and rationing test to measure the kinetic response to the movement of the player defender basketball junior time. Chosen as the r
... Show MoreThis work presents a five-period chaotic system called the Duffing system, in which the effect of changing the initial conditions and system parameters d, g and w, on the behavior of the chaotic system, is studied. This work provides a complete analysis of system properties such as time series, attractors, and Fast Fourier Transformation Spectrum (FFT). The system shows periodic behavior when the initial conditions xi and yi equal 0.8 and 0, respectively, then the system becomes quasi-chaotic when the initial conditions xi and yi equal 0 and 0, and when the system parameters d, g and w equal 0.02, 8 and 0.09. Finally, the system exhibits hyperchaotic behavior at the first two conditions, 0 and 0, and the bandwidth of the chaotic
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