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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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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 Dec 01 2023
Journal Name
Materials Today Sustainability
Structure and performance of polyvinylchloride microfiltration membranes improved by green silicon oxide nanoparticles for oil-in-water emulsion separation
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Publication Date
Wed Aug 10 2016
Journal Name
Al-nahrain
Synthesis and characterization of some Anti-bactrial Active Transition Metal Complexes of N-12-(2-phenyl hydrazinyl) phenyl [ benzothiohydrazide
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Publication Date
Mon Apr 01 2019
Journal Name
Biochemical And Cellular Archives
No etiological role of Herpes Simplex Virus and Toxoplasma Gondii infections in systemic lupus erythematosus of Iraqi Female Patients
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Systemic lupus erythematosus (SLE) is one of the autoimmune disorders, generated by a production of specific autoantibodies against self-antigens before the occurrence of clinical symptoms. The etiology of disease is still unknown, although there have been several infectious agents that have been associated with SLE development, especially in genetically predisposed individuals. Herpes simplex virus-I and -II (HSV-I and -II) and Toxoplasma gondiiare two infectious agents that have been suggested to be involved in SLE etiology. Accordingly, the present study assessed anti- HSV-I and -II and anti-T. gondii IgG and IgM antibodies by enzyme linked immunosorbent assay in sera of 64 SLE female patients and 32 healthy control women. The patients w

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Publication Date
Sun Jun 27 2021
Journal Name
Iraqi National Journal Of Nursing Specialties
Assessment of Women’s Knowledge about Health Promotion after Cesarean Delivery at Maternity and Pediatric Hospital in Al-Samawa City
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Objective(s): To assess women’s knowledge about health promotion after a cesarean delivery and to determine the association between women’s knowledge and their demographic data of age, level of education, and monthly income.
Methodology: A descriptive design is carried out to assess women’s knowledge about health promotion after cesarean delivery at Maternity and Pediatric Hospital in Al-Samawa City. This study starts from 26th of September 2020 up to 16th March 2021. Sample of (100) woman who are at reproductive age, pregnant (prime or multipara) who have planned to have birth by elective cesarean section or had previous elective caesarian section without medical indication or women who had cesarean section with medical indicat

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Publication Date
Sun Jun 05 2016
Journal Name
Baghdad Science Journal
Measurement of radionuclides in imported Coffee Consumed in Basra southern of Iraq and estimation of its annual effective dose
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Radioactive elements were identified in samples of imported coffee consumed in the province of Basra using gamma spectrometry SAM940TM. It is a scintillation detector of NaI(Tl) crystal and the dimensions of 2×2 inch. We have identified specific concentration As(Bq/kg) and annual effective dose D(Sv/y) for radioactive elements (_^40)K, (_^131)I, (_^134)Cs and (_^137)Cs. The estimated average effective dose for adults from coffee samples were found to be 0.037mSv/y, 88.434nSv/y, 46.909nSv/y, 27.212nSv/y for ((_^40)K,(_^131)I,(_^134)Cs,(_^137)Cs) respectively. The present results of the study revealed that the radioactivity was relatively low in the coffee and within the permissiblelimit.

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Publication Date
Sun Jun 02 2024
Journal Name
Methods And Objects Of Chemical Analysis
Simultaneous Spectrophotometric Determination of Piroxicam, Naproxen, Diclofenac Sodium and Mefenamic Acid in Pharmaceutical Formulations by Partial Least Squares Method
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A chemometric method, partial least squares regression (PLS) was applied for the simultaneous determination of piroxicam (PIR), naproxen (NAP), diclofenac sodium (DIC), and mefenamic acid (MEF) in synthetic mixtures and commercial formulations. The proposed method is based on the use of spectrophotometric data coupled with PLS multivariate calibration. The Spectra of drugs were recorded at concentrations in the linear range of 1.0 - 10 μg mL-1 for NAP and from 1.0 - 20 μg mL-1 for PIR, DIC, and MEF. 34 sets of mixtures were used for calibration and 10 sets of mixtures were used for validation in the wavelength range of 200 to 400 nm with the wavelength interval λ = 1 nm in methanol. This method has been used successfully to quant

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Publication Date
Thu Oct 01 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Regulation of HbA1c of uncontrolled diabetic type II obese and normal weight patients by oral hygiene performance (Comparative study)
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Background: The association between periodontal diseases incidence and development and the metabolic diseases as Diabetes Mellitus and Obesity are recently have attract great deal of researchers attention and investigation. The periodontal health proved to reduce the systemic inflammatory reactions and positively improve the glycemic control of diabetes Type2 patients. The aim of the study was to investigate the influence of oral hygiene control on the glycemic control of obese and normal weight moderately controlled Diabetic Type 2 patients, in addition to study the association of obesity with the gingival inflammation. Materials and Methods: Cross sectional study of three months duration. Included 30 moderately controlled diabetic type2 p

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Publication Date
Thu Jun 01 2023
Journal Name
Iraqi Journal Of Physics
Cytotoxic Activity of CuO NPs Prepared by PLAL Against Liver Cancer (Hep-G2) Cell Line and HdFn Cell Lines
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A simple physical technique was used in this study to create stable and cost-effective copper oxide (CuO) nanoparticles from pure copper metal using the pulsed laser ablation technique. The synthesis of crystalline CuO nanoparticles was confirmed by various analytical techniques such as particle concentration measurement using atomic absorption spectrometry (AAS), field emission scanning electron microscopy (FE-SEM), the energy dispersive X-ray (EDX), and X-ray diffraction (XRD) to determine the crystal size and identify of the crystal structure of the prepared particles. The main characteristic diffraction peaks of the three samples were consistent. The corresponding 2θ is also consistent, and the cytotoxicity of the nanoparticles was

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Publication Date
Thu Feb 07 2019
Journal Name
Iraqi Journal Of Laser
Evaluation of 532 nm Q-Switched Nd:YAG Laser and Acid Etching of Class V Composite Restoration: Comparative Histological Study
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Laser etching may be an alternative to acid etching of enamel and dentin. Several characteristics of irradiated dental hard tissues have been considered advantageous, microscopically rough surfaces without demineralization, open dentinal tubules without smear layer production and dentin surface sterilization. The aim of this study is to determine and compare histology the microleakage in class V cavity restored with a light cured composite after conditioning the samples(tooth surface) with 1-acid etching, 2-Q-switched Nd:YAG Laser etching and finally 3- acid and laser etching. Materials and methods: Twenty four non carious human extracted teeth were used in this study. The samples were equally grouped into four groups of six teeth each.

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Publication Date
Tue Jan 01 2019
Journal Name
International Journal Of Civil Engineering And Technology
Prediction of bearing capacity, angle of internal friction, cohesion, and plasticity index using ANN (case study of Baghdad, Iraq)
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In the last few years, the use of artificial neural network analysis has increased, particularly, in geotechnical engineering problems and has demonstrated some success. In this research, artificial neural network analysis endeavors to predict the relationship between physical and mechanical properties of Baghdad soil by making different trials between standard penetration test, liquid limit, plastic limit, plasticity index, cohesion, angle of internal friction, and bearing capacity. The analysis revealed that the changes in natural water content and plastic limit have a great effect on the cohesion of soil and the angle of internal friction, respectively. . On the other hand, the liquid limit has a great impact on the bearing capacity and

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