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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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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 Mar 30 2001
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Analytical Presentation for Constant Terminal Pressure Functions (Reservoir Oil-Well Systems)
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Publication Date
Sat Oct 01 2022
Journal Name
Nasaq
Zora Neale Hurston’s Their Eyes were Watching God: An Analytical Reading
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IDENTITY CRISIS

Publication Date
Sat Jul 20 2024
Journal Name
Journal Of Interdisciplinary Mathematics
Analytical solutions via coupled Elzaki adomian decomposition method for some applications
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An efficient combination of Adomian Decomposition iterative technique coupled Elzaki transformation (ETADM) for solving Telegraph equation and Riccati non-linear differential equation (RNDE) is introduced in a novel way to get an accurate analytical solution. An elegant combination of the Elzaki transform, the series expansion method, and the Adomian polynomial. The suggested method will convert differential equations into iterative algebraic equations, thus reducing processing and analytical work. The technique solves the problem of calculating the Adomian polynomials. The method’s efficiency was investigated using some numerical instances, and the findings demonstrate that it is easier to use than many other numerical procedures. It has

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Publication Date
Tue Jan 01 2019
Journal Name
Indian Journal Of Public Health Research & Development
Analytical Study of Strategic Watch at Paralympic Committee Members in Iraq
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Publication Date
Tue Jan 31 2017
Journal Name
Journal Of Engineering
Sustainable Investment In Architectural Heritage Buildings (Analytical Study Of Arabic Models)
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 Heritage is considered as the civilization and cultural wealth accumulated over the . centuries, whereas architectural heritage is the physical witness of that civilization. Despite the fact that architectural heritage is the most important effort for economic development of any communit,، it suffers from deterioration and neglection especially in the Arab communities. Recently awareness has increased about the importance of investing on architectural heritage generally and sustainable investment particularly. The goal of investment process in heritage areas is to revive economic activity in addition to attempt to revive the heritage and community values. Research aims to examine the relationship between sustainable investment and

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Publication Date
Mon Mar 15 2021
Journal Name
Al-adab Journal
A Socio-Pragmatic Analysis of Responses to Impoliteness in some Selected English and Arabic Literary Texts
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Publication Date
Mon Apr 27 2020
Journal Name
Journal Of Mechanics Of Continua And Mathematical Sciences
A COMPARISON OF TOPOLOGICAL KRIGING AND AREA TO POINT KRIGING FOR IRREGULAR DISTRICT AREA IN IRAQ
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Publication Date
Mon Jan 16 2023
Journal Name
Iraqi National Journal Of Nursing Specialties
Dependence Severity, Locus of Control, and Readiness to Change in Male Alcoholic Clients: A Correlational Study
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Objectives: To assess the level of dependence severity, locus of control, and readiness to change in male alcohol clients and measure the correlation between dependence with a locus of control and readiness to change.

Methodology: A descriptive correlational design was conducted in the substance use rehabilitation centers at psychiatric teaching hospitals in Baghdad city from November /2021 to May 2022. The instrument of the study was designed by using sociodemographic, the clinical characteristics of the client, the Short-form Alcohol Dependence Data Questionnaire (SADD), Drinking Related Internal-External Locus of Control Scale: (DRIE), and the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES). The data was co

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Publication Date
Tue Jun 30 2009
Journal Name
Al-kindy College Medical Journal
Abdominal Distention and Acute Urinary Retention secondary to Congenital Distal Vaginal Obstruction in a Newborn Female
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Congenital distal vaginal obstruction is usually asymptomatic in a newborn female. On rare occasions, it may present as an acute emergency with life threatening complications.This paper is reporting the rare condition of two newborn females presenting urgently with abdominal distension and acute urinary retention as a result of congenital distal vaginal Obstruction. The case history and urgent management shall be presented and both conditions shall be discussed.

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Publication Date
Thu Aug 04 2022
Journal Name
Contemporary Nurse
ICU nurses’ safety performance related to respect for safety and management commitment: A cross-sectional study
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