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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
Objective: To identify the effectiveness of instruction oriented intervention for primipara women upon episiotomy and self
perineal care.
Methodology: A quasi-experimental study was carried out to determine the effectiveness of instruction-oriented
intervention for primipara women upon episiotomy and self-perineal care. A purposive "non-probability" sample of (60)
primipara mothers was selected from Ibn AL-Balady Pediatric and Maternity Hospital, Al-russafa, Baghdad. The sample
has been divided into two groups; (30) primipara women who were considered as a study group, and another (30) primipara
women who were considered as a control one. The study group was exposed to an instruction-oriented intervention. While,
the
The primary purpose of this paper is to introduce the, N-coprobabilistic normed space, coprobabilistic dual space of N-coprobabilistic normed space and give some facts that are related of them.
Dust storms are a natural phenomenon occurring in most areas of Iraq. In recent years, the study of this phenomenon has become important because of the danger caused by increasing desertification at the expense of the green cover as well as its impact on human health. In this study is important to devote the remote sensing of dust storms and its detection.Through this research, the dust storms can be detected in semi-arid areas, which are difficult to distinguish between these storms and desert areas. For the distinction between the dust storm pixels in the image with those that do not contain dust storm can be applied the Normalized Difference Dust Index (NDDI) and Brightness Temperature variation (BTV). MODIS sensors that carried
... Show MoreThere is no doubt that Agricultural Policy is the main responsible for the degrading in Agricultural sector in Iraq during the period 2003-2013, and that was very clear from magnitude of indicators because of little sharing of each of agricultural product in GDP because it was (9.38%) in average during the study period and the annual changing of it was negative (-5.82%), and there is increasing in deficit of trade balance in Agriculture during the study period about (4185.73) million US$, and the percentage of agricultural exports from total exports was (0.14%) in average only. The foreign trade policy in Agricultural products also cannot determine map of Revealed Comparative Advantage (RCA) of Agricultural products and crops. The study sh
... Show MoreThis work aimed to study the effect of laser surface treatment on the mechanical characteristics and corrosion behaviour of grey cast iron type A159. Many technical applications used conventional surface treatment, but laser surface hardening has recently been used to enhance the surface properties of many alloys. The mechanical characteristics, including microstructure, microhardness, and wear resistance of A159 grey cast iron, were studied, in addition to corrosion behaviour. The experimental laser parameters in this work were 0.9, 1.2, and 1.5 KW power with continuous wave carbon dioxide lasers with scanning speeds of 10 and 12 mm/s were used. The results found that phase-transitional alterations in microstructure were influenced by lase
... Show MoreA method is developed for the determination of iron (III) in pharmaceutical preparations by coupling cloud point extraction (CPE) and UV-Vis spectrophotometry. The method is based on the reaction of Fe(III) with excess drug ciprofloxacin (CIPRO) in dilute H2SO4, forming a hydrophobic Fe(III)- CIPRO complex which can be extracted into a non-ionic surfactant Triton X-114, and iron ions are determined spectrophotometrically at absorption maximum of 437 nm. Several variables which impact on the extraction and determination of Fe (III) are optimized in order to maximize the extraction efficiency and improve the sensitivity of the method. The interferences study is also considered to check the accuracy of the procedure. The results hav
... Show MoreOral squamous cell carcinoma (OSCC) is the most common malignant neoplasm of the oral mucosa. Human papillomavirus (HPV) virus cause a broad scope of diseases from benign to invasive tumors, types 16 and 18 classified as carcinogenic to humans. This study aimed to provide the first molecular characterization of HPV types in Iraq. Thirty-five unstimulated whole saliva samples were collected from histopathologically confirmed patients with oral cancer were enrolled in this study. Genomic DNA was extracted from exfoliating cells to amplify HPV-DNA using HPV-L1 gene sequence primers by polymerase chain reaction method (PCR), the viral genotyping was performed using direct sequencing method. HPV genotypes identified were deposited in Gen
... Show MoreThe question of word–formation motivation is one of the most urgent problems of morphological features of diminutive vocabulary in the languages of different structures, Arabic – Semitic and Russian - Slavic. The relevance of this question lies in the fact that the analysis of morphological elements of word-formation motivation plays an important role not only in identifying formal and semantic connections between different units of the same language, but also has an applied value in the comparative study of different languages. Taking in to account that word-formation motivation is usually considered sequentially in order to identify motivational relationships of this type of vocabulary, we will study motivation in comparative analy
... Show MoreThe research illustrated that the theory of constraints is "A group of concepts and basics that aim at helping the management in order to determine the difficulties and how to overcome these difficulties through determining the necessary change and how these change can be done efficiently and effectively ".
The research showed that the theory of constraint including its tools calls for magnifying throughput, constricting the product cycle , determining the optimal production mix , utilization of scare resources and canceling the idle time , that achieving throughput increasing then increasing profit .
Moreov
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