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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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 objectives of this paper was the development of a novel ligand, L, which was achieved in two stages: ligand is synthesised by reducing the result of the reaction between cyclohexane-1,2-diamine and 4-hydroxy-3,5-dimethoxycy clohexane-1-carbaldehyde, followed by the production of the 4,4’-((1E,1’E)-(1,2 phenylenebis(azanylylidene))bis(methanylylidene))bis(2,6-dimethoxyphenol) precursor (P). While studying corrosion inhibition (copper alloy) in acid solution by weight loss, compounds were characterised using 1H, 13CNMR (for ligand (L) and (P)), FT-IR and UV spectra, melting point, molar conductivity, %C, %H and %N, %M, and magnetic susceptibility. The complex’s octahedral structure is inferred from the bidentate coordination
... Show MoreBackground: Many countries recommend the use of long-acting reversible contraceptive intrauterine device immediately after cesarean delivery. The cesarean delivery rate in Iraqi public hospitals is 32.2% and may reach 85.8% in private hospitals. Immediate post-partum intrauterine device insertion at cesarean is rarely done in Iraq.
Objectives: To assess the safety and practicality of immediate post-partum intrauterine device insertion during cesarean delivery for family planning and pregnancy spacing in Iraqi women.
Subjects and Methods: A single arm clinical trial included 150 eligible women who attended Al-Elwiyah Maternity Teaching Hospital or Al Hayat Rahibat Hospita
... Show MoreIn this paper, the dynamic behaviour of the stage-structure prey-predator fractional-order derivative system is considered and discussed. In this model, the Crowley–Martin functional response describes the interaction between mature preys with a predator. e existence, uniqueness, non-negativity, and the boundedness of solutions are proved. All possible equilibrium points of this system are investigated. e sucient conditions of local stability of equilibrium points for the considered system are determined. Finally, numerical simulation results are carried out to conrm the theoretical results.
Objective: To evaluate the functional outcome of percutaneous cross two K wires fixation for Gartland types II and III fractures of humerus. Methodology: This prospective study included80 patients with supracondylar humeral fracture, who underwent closed reduction and fixation by two crossed Kirschner wires. We included children with age < 15 years with closed fractures with Gartland types II and III, while the patient with vascular injury, open, irreducible fractures were excluded. The patients were following up for 6 months and assessed functionally by Flynn’s criteria. Results: The mean age of patients was 8.1 years. Trauma while child playing was the main mechanism of injury in 43 (59.8%) children and 46 (57.5%) fractures were of the
... Show MoreBiodegradable polymers have garnered increasing attention as eco-friendly alternatives to conventional petroleum-derived plastics, which pose a global environmental challenge due to their difficult recycling and slow degradation. This study focuses on the preliminary evaluation of surface functional properties of chitosan films reinforced with TiO₂ or ZnO nanoparticles (NPs). These films were prepared at different loading ratios using the solution-casting method. Structural and morphological properties were characterized using FTIR and FESEM, while functional properties were evaluated by surface wettability, UV–Vis spectroscopy, thermogravimetric analysis and antibacterial activity testing. FTIR results showed significant changes in abs
... Show MoreThe performance in the 110-meter hurdles at the sprint hurdles event is determined by several physical and physiological qualities. Nonetheless, relatively little attention has been paid to the predictability of such factors in determining race performance. This study seeks to fill this gap by establishing the most critical physical and physiological characteristics affecting elite hurdlers’ performance and creating a statistical model that predicts race times from the identified measurable characteristics. The study utilized a descriptive research design in-volving six elite male hurdlers, all of whom completed a battery of standardized physical and functional tests to assess their explosive lower-body strength, agility, reaction
... Show MoreThe current research dealt with the study of space compatibility and its role in enhancing the functional aspect of the design of the interior spaces of isolation hospitals by finding a system or format that is compatible with the nature of the changes occurring in the structure and function of the space system, as well as contributing to enhancing compatibility between the functional aspect and the interior space. Therefore, the designer must The interior is the study of the functional and spatial aspects as they are the basic aspects for achieving suitability, and through the interaction between the person and the place, the utilitarian performance characteristics are generated that the interior designer is interested in and tries to d
... Show MoreNigella sativa seeds (NSS) are reputed traditionally and scientifically as a potent agent that promote milk secretion (galactagogue), but their mechanism of action is studied trivially. One suggestion was that these seeds are bio-transformed to sex hormones within the ovaries. Therefore, this investigation was designated to throw light on the action of these seeds in the absence of ovaries i.e. in male rats. Thirty Norway male albino rats were used in this investigation. They were divided into experimental (n=20,fed NSS 2g/ Kg body weight /day for 14 days) and control (n=10, fed placebo for 14 days). After sacrifice mammary gland and blood samples were obtained. Experimental rats revealed a significant increase (p (0.01>in
... Show MoreThe research included five sections containing the first section on the introduction of the research and its importance and was addressed to the importance of the game of gymnastic and skilled parallel effectiveness and the importance of learning, but the problem of research that there is a difference in learning this skill and difficulty in learning may be one of the most important reasons are fear and fear of falling and injury, And a lack of sense of the movement of the movement is one of the obstacles in the completion of the skill and the goal of research to design a device that helps in learning the skill of descending Almtor facing with half a cycle according to the typical locomotor track on the parallel device of the technical men'
... Show Morethe use of diffrent concectration of Na and Mg ions were shown to causes in increase in the bindings at oncentration