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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
Given a matrix, the Consecutive Ones Submatrix (C1S) problem which aims to find the permutation of columns that maximizes the number of columns having together only one block of consecutive ones in each row is considered here. A heuristic approach will be suggested to solve the problem. Also, the Consecutive Blocks Minimization (CBM) problem which is related to the consecutive ones submatrix will be considered. The new procedure is proposed to improve the column insertion approach. Then real world and random matrices from the set covering problem will be evaluated and computational results will be highlighted.
A prey-predator interaction model has been suggested in which the population of a predator consists of a two-stage structure. Modified Holling's disk equation is used to describe the consumption of the prey so that it involves the additional source of food for the predator. The fear function is imposed on prey. It is supposed that the prey exhibits anti-predator behavior and may kill the adult predator due to their struggle against predation. The proposed model is investigated for existence, uniqueness, and boundedness. After determining all feasible equilibrium points, the local stability analyses are performed. In addition, global stability analyses for this model using the Lyapunov method are investigated. The chance of occurrence of loc
... Show MoreThe aim of the present study was to demonstrate the possible role of statins on the inflammatory biomarkers in patients with periodontal disease (PD) This cross-sectional study involved 74 patients with PD and/or dyslipidemia divided into Group A: 34 patients with PD (nonstatins users); Group B: 40 patients with PD (statins users); and Group C: 30 healthy controls. Total cholesterol (TC), triglyceride (TG) and high-density lipoprotein, C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-α), and malondialdehyde (MDA) were measured . Blood pressure prolife and indices of PD were evaluated in each group. Statistical analysis was conducted by using SPSS version 20.0.
This study presented an endeavour to integrate the value chain activities with the Balanced Scorecard for a comprehensive evaluation of an organization’s strategic performance. It also demonstrated the connection and the integration of the activities of the value chain with the Balanced Scorecard. The financial measurement was linked with non-financial measurement by integrating these techniques to achieve an appropriate performance that supports all aspects of the organizational performance. Consequently, the research problem in this study emerged, which is due to the concentration of many organizations on the measurement of financial performance. Notably, the latter caused the decline of some organizations from the competitive market. T
... Show MoreThe use of Near-Surface Mounted (NSM) Carbon-Fiber-Reinforced Polymer (CFRP) strips is an efficient technology for increasing flexural and shear strength or for repairing damaged Reinforced Concrete (RC) members. This strengthening method is a promising technology. However, the thin layer of concrete covering the NSM-CFRP strips is not adequate to resist heat effect when directly exposed to a fire or at a high temperature. There is clear evidence that the strength and stiffness of CFRPs severely deteriorate at high temperatures. Therefore, in terms of fire resistance, the NSM technique has a significant defect. Thus, it is very important to develop a set of efficient fire protection systems to overcome these disadvantages. This pape
... Show MoreBackground: The present study aimed to assess the distribution, prevalence, severity of malocclusion in Baghdad governorate in relation to gender and residency Materials and Methods: A multi-stage stratified sampling technique was used in this investigation to make the sample a representative of target population. The sample consisted of 2700 (1349 males and 1351 females) intermediate school students aged 13 years representing 3% of the total target population. A questionnaire was used to determine the perception of occlusion and orthodontic treatment demand of the students and the assessment procedures for occlusal features by direct intraoral measurement using veriner and an instrument to measure the rotated and displaced teeth. Results a
... Show MoreIn this study, vegetable tanned leather waste of cow (VTLW-C) is used as adsorbent for removing methyl violet 10B dye from aqueous solution. The VTLW-C adsorbent was characterized by FTIR and SEM in order to evaluate its surface properties before using in adsorption experiments. Batch adsorption method was applied to study the effect of different factors such as weight of leather waste, time of shaking, and starting concentration of methyl violet 10B dye. Different isothermal models such as Langmuir, Freundlich, Temkin and Dubinin-Radushkevich (D–R) were used to analyze the experimental data. Kinetic study proceeds using (PFO) kinetic model and (PSO) kinetic model. The results showed better agreement with the Freundlich model; this means
... Show MoreA new series of Fe (III) , Co (II) , Ni (II) and Cu (II) complexes of the Schiff base, 5 (2-hydroxy benzylidine) -2-thio ether -1, 3, 4-thiadiazole were prepared and characterized .The imine behaves as a bidentate. The nature of bonding and the stereochemistry of the complexes were deduced from metal analyses, infrared, electronic spectra,magnetic susceptibility and conductivity measurements, an octahedral geometry was suggested for all complexes except the copper complex has a square planar geometry .preliminary in vitro tests for antimicrobial activity show that all the prepared compounds except iron complex display good activity to gram positive Staphelococcus aures and gram negative Escherchia coli.
A new ligand complexes have been synthesis from reaction of metal ions of Mn(II), Co(II), Ni(II), Cu(II), Zn(II), Cd(II), Hg(II), Pd(II) and Pt(II) with schiff base LH. 5-[(2-Hydroxy-naphthalen-1-ylmethylene)-amino]-2-phenyl-2,4-dihydro-pyrazol-3-one, this ligand was characterized by Fourier transform infrared (FTIR), UV-vis, 1H, 13CNMR, and mass spectra. All complexes were characterized by techniques micro analysis C.H.N, UV-vis and FTIR spectral studies, atomic absorption, chloride content, molar conductivity measurements and magnetic susceptibility. The ligand acts as bidentate, coordination through nitrogen atom from azomethin group and deprotonated phenolic oxygen atom. The spectroscopic and analytical measurements showed that
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