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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
This research is concerned with the re-analysis of optical data (the imaginary part of the dielectric function as a function of photon energy E) of a-Si:H films prepared by Jackson et al. and Ferlauto et al. through using nonlinear regression fitting we estimated the optical energy gap and the deviation from the Tauc model by considering the parameter of energy photon-dependence of the momentum matrix element of the p as a free parameter by assuming that density of states distribution to be a square root function. It is observed for films prepared by Jackson et al. that the value of the parameter p for the photon energy range is is close to the value assumed by the Cody model and the optical gap energy is which is also close to the value
... Show MoreThe investment portfolio of financial instruments & banking relatively new in the banking sector & the world of investment &capital markets in spite of its importance & its advantages in terms of the nature of the diversity of investment instruments as well as reduce the risk of investment & its contribution to the revitalization of the banks & the financial market , economic, &characterized by developments accelerated under information & communications technology , as is the portfolio tool vehicle of investment tools that provide for people who want to invest & they can not manag
... Show MoreThe dramatic series on television have a great impact on people’sattitudes towards dialects of language varieties, by relating theconceptual pictures or prototypes presented by series’ characters tothose dialects. This study aims to show the influence of TV series onIraqi university learners’ gender and age in relating positive ornegative semantic qualities to their dialects. To this end, 150 Iraqi EFLlearners have participated in this study to examine their attitudestowards Baghdadi, Mousli and Nasiriya dialects. The data arecollected by Lambert, Hodgson, Gardner, Fillenbaum's (1960)matched guise technique and then labeled by Willmorth’s (1988)subjective reaction test. A structured interview is conducted to supportthe data
... Show MoreThe current research aims to determine the impact of the cognitive reconstruction program on the development of psychological hardness among middle school students through the experimental verification of three hypotheses. The research sample consisted of (16) out of (450) students selected from Ibn Rushud preparatory school- Al-Rusafa 2. These participants have been randomly distributed into two equal groups. The researcher has used the method of cognitive reconstruction with the experimental group, whereas with the controlling group, he used nothing. The researcher has further used the scale of psychological hardness of Kobassa with the participants; the scale has been built in a way that suits the sample of the study, which consisted
... Show MoreLet be a ring. Given two positive integers and , an module is said to be -presented, if there is an exact sequence of -modules with is -generated. A submodule of a right -module is said to be -pure in , if for every -Presented left -module the canonical map is a monomorphism. An -module has the -pure intersection property if the intersection of any two -pure submodules is again -pure. In this paper we give some characterizations, theorems and properties of modules with the -pure intersection property.
Let be a ring. Given two positive integers and , an module is said to be -presented, if there is an exact sequence of -modules with is -generated. A submodule of a right -module is said to be -pure in , if for every -Presented left -module the canonical map is a monomorphism. An -module has the -pure intersection property if the intersection of any two -pure submodules is again -pure. In this paper we give some characterizations, theorems and properties of modules with the -pure intersection property.
In recent years, there has been a rise in interest in the study of antibiotic occurrence in the aquatic environment due to the negative consequences of prolonged exposure and the potential for bacterial antibiotic resistance. Most antibiotic residues from treated wastewater end up in the aquatic environment as they are not eliminated in facilities that treat wastewater. Antibiotics must be identified in influent and effluent wastewater using reliable analytical techniques for several reasons. Firstly, monitoring antibiotic presence in aquatic environments. Secondly, assessing environmental risks, computing wastewater treatment plant removal efficiencies, and estimating antibiotic consumption. Therefore, this work aims to provide an overview
... Show MoreThis study was undertaken to introduce a fast, accurate, selective, simple and environment-friendly colorimetric method to determine iron (II) concentration in different lipstick brands imported or manufactured locally in Baghdad, Iraq. The samples were collected from 500-Iraqi dinars stores to establish routine tests using the spectrophotometric method and compared with a new microfluidic paper-based analytical device (µPAD) platform as an alternative to cost-effective conventional instrumentation such as Atomic Absorption Spectroscopy (AAS). This method depends on the reaction between iron (II) with iron(II) selective chelator 1, 10-phenanthroline(phen) in the presence of reducing agent hydroxylamine (HOA) and sodium acetate (NaOAc) b
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