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Analytical Physicochemical and Functional Studies to Compare AryoTrust, a Follow-On Biologics, with the Originator Trastuzumab (Herceptin)
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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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.

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Publication Date
Fri May 14 2010
Journal Name
Al-mustansiriyah
Synthesis, Spectroscopic and Biological Studies of Some Metal Complexes with 1, 2 bis-(orthoaminophenylthio) ethane
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Publication Date
Sat Dec 15 2018
Journal Name
Research Journal Of Pharmaceutical, Biological And Chemical Sciences
Synthesis, Spectroscopic and Antimicrobial Studies of Mixed Ligand Metal (II) Complexes with three amino acids
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The research includes synthesis and identification of novel three amino acids ligands complexes of some heavy metal (II) ions by using the amino acids like glycine, L-alanine and L-valine. New metal mixed ligand complexes with amino acids are prepared the reaction by reacting the three amino acids with the metals(II) chloride by using 50% ethanolic solution and 50% distall water in the molar ratio [1:1:1:1] ( M:Gly:Ala:Val) except for Co(II) and Ni(II) complexes were found after diagnosis the coordination with both Lalanine and L-valine. The prepared complexes identified by using physical properties, flame atomic absorption and conductivity measurements, in addition, mass, FT.IR and UV.vis spectrum as well magnetic moment data. The general

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Publication Date
Mon Jan 07 2019
Journal Name
Journal Of Pharmaceutical Sciences And Research
Synthesis, Spectral Studies and Microbial Evaluation of Azo Dye Ligand Complexes with Some Transition Metals
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1-(4-amino-3-(benzo[d]thiazol-2-yldiazenyl)phenyl)ethanone has been synthezied by reaction the diazonium salt of 2-aminobenzothiazole with 4-aminoacetophenone. Specroscopic studies ( FTIR,UV-Vis, 1H and 13CNMR) and microelemental analysis (C.H.N.S.O) are use to identified of the azo ligand. Metal chelates of some transition metals were performed as well depicted. Complexes were identified using atomic absorption of flame, elemental analysis, infrared and UV-Vis spectral process as well conductivity and magnetic quantifications. Nature of compounds produced have been studied followed the mole ratio and continuous contrast methods, Beer's law followed during a concentration scope (1×10-4 - 3×10-4 mol/L). height molar absorbtivity of compoun

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Publication Date
Fri Oct 20 2023
Journal Name
Baghdad Science Journal
Synthesis, Characterization , Thermal Studies and Antioxidant Activities of Transition Metal Complexes with Azo Dye ligand
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Diazotization reaction between 1-(2,4,6-Trihydroxy-phenyl)-ethanone and diazonium salts was carried out resulting in ligand 4-(3-Acetyl-2,4,6-trihydroxy-phenylazo)-N-(5-methyl-isoxazol-3-yl)-benzenesulfonamide, this in turn reacted with the next metal ions (V4+ , Cr3+ , Mn2+ and Cu2+) forming stable complexes with unique geometries such as (Octahedral for both Cr3+ , Mn2+ and Cu2+ ,squar pyramidal for V4+). The creation of such complexes was detected by employing spectroscopic means involving ultraviolet-visible which proved the obtained geometries, fourier transfer proved the formation of azo group and and the coordination with metal ion through it. Pyrolysis (TGA & DSC) studies proved the coordination of water residues with me

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Publication Date
Sat May 02 2020
Journal Name
Karbala Journal Of Physical Education Sciences
The effect of using a designed device to develop the technical performance of the descending landing skill facing with half a cycle on the parallel device of the technical men's
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AS Salman, SK Hameed…, Karbala Journal of Physical Education Sciences, 2020

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Publication Date
Thu Dec 24 2020
Journal Name
Advances In Civil Engineering
Analytical study on torsional behavior of concrete beams strengthened with fiber reinforced polymer laminates using softened truss model
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This study aimed at evaluating the torsional capacity of reinforced concrete (RC) beams externally wrapped with fiber reinforced polymer (FRP) materials. An analytical model was described and used as a new computational procedure based on the softened truss model (STM) to predict the torsional behavior of RC beams strengthened with FRP. The proposed analytical model was validated with the existing experimental data for rectangular sections strengthened with FRP materials and considering torque-twist relationship and crack pattern at failure. The confined concrete behavior, in the case of FRP wrapping, was considered in the constitutive laws of concrete in the model. Then, an efficient algorithm was developed in MATLAB environment t

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Publication Date
Tue Aug 03 2021
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
The Role of Integrated Reporting in Reducing Information Asymmetry: Analytical Research of A sample of Iraqi Banks listed on the Iraq Stock Exchange
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Allowing Iraqi companies to use multiple systems and policies leads to varying levels of disclosure and no high symmetry between report preparers and users, and that the adoption of integrated reporting can reduce information asymmetry. The theoretical side addressed the concepts of these variables, and in the practical side the binary variable (0, 1) was used. To compensate for the value of the independent variable (integrated reporting) based on the Central Bank of Iraq’s classification of banks according to the (CAMLES) index, and the dependent variable (information asymmetry) was measured through two measures (price difference, unusual return), the research community was represented by (5) Banks out of the total of banks li

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Publication Date
Mon Dec 01 2014
Journal Name
Journal Of Economics And Administrative Sciences
The Effect of importance in the Intellectual Capital On Internal control Systems Analytical Research in A sample of general inspectors’ offices in Iraq
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The research aims to know the influence of the intellectual capital on the internal control system in a sample of General Inspection Offices in Iraq. The research includes a sample of individuals who are working in these offices total sample (46) individuals distributed according to functional levels (General Inspector, Deputy Inspector General, and Director) , The data and information were collected by using questionnaire, which is done for this purpose, as well as personal interviews in order to reach to the results that achieve the aim of this research , Two hypotheses were formed , the first hypothesis consists of (4) secondary hypothesis , All these hypotheses were tested by using statistical tools such as (percentages, freq

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Publication Date
Sat Sep 28 2024
Journal Name
Journal Of Physical Education
Special exercises using tools and their effect on learning the skill of landing with Salto backward tucked to stand on the horizontal bar
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Special exercises in individual games are an important pillar in learning their basic skills. The aim of the research is to prepare special exercises using tools and their effect on learning the skill of landing with Salto backward tucked to stand - knowing the effect of special exercises using tools and their effect on learning the skill of landing with Salto backward tucked to stand on the horizontal bar. Either the research assumes the existence of significant differences in the pre- and post-tests in learning the skill of landing with Salto backward tucked to stand on the horizontal bar in favor of the post-test. The researchers used the experimental method with a single sample design to suit the research problem, as the researc

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Publication Date
Sun Sep 26 2021
Journal Name
Modern Sport
The effect of physical exertion exercises using electrical muscle stimulation on the development of some physical and functional characteristics of women aged (40-45) years
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The researchers have recently noticed the interest in the problem of overweight and how to find solutions to it until it is now at the forefront in terms of innovating various and different methods and treatment methods, and the interest in developing health fitness is one of the most important requirements of physical activity for the trainees, which led to the multiplicity of sports activities that promote the health aspect For the individual, in addition to the aesthetic aspect, the problem lies in not adopting training programs according to codified scientific foundations aiming, in addition to reducing weight, to raise the general health level of the trainee participating in fitness institutes, as the trainers do not follow the

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