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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
Four new complexes of Pd(II), Pt(II) and Pt(IV) with DMSO solution of the ligand 8-[(4-nitrophenyl)azo]guanine (L) have been synthesized. Reaction of the ligand with Pd(II) at different pH gave two new complexes, at pH=8, a complex of the formula [Pd(L)2]Cl2.DMSO (1) was formed, while at pH=4.5,the complex[Pd(L)3]Cl2.DMSO (2) was obtained. Meanwhile, the reaction of the ligand with Pt(II) and Pt(IV) revealed new complexes with the formulas[Pt(L)2]Cl2.DMSO (3)and [Pt(L)3]Cl4.DMSO (4) at pH 7.5 and 6 respectively.
All the preparations were performed after fixing the optimum pH and concentration. The effect of time on the stability of these complexes was checked. The stoichiometry of the complexes was determined by the mole ratio and Job
Foundations supporting reciprocating engines, radar towers, turbines, large electric motors, and generators, etc. are subject to vibrations caused by unbalanced machine forces as well as the static weight of the machine. If these vibrations are excessive, they may damage the machine or cause it not to function properly. In the case of block foundation, if changes in size and mass of the foundation do not lead to a satisfactory design, a pile foundation may be used. In this study, the dynamic response of piles and pile Groups in dry sand is investigated experimentally. The analysis involves the displacement response under harmonic excitation. In addition, a numerical modeling by using finite element method with a three-dimensional formula
... Show MoreViscosities (η) and densities (ρ) of atenolol and propranolol hydrochloride in water and in concentrations (0.05 M) and (0.1 M) aqueous solution of threonine have been used to reform different important thermodynamic parameters like apparent molal volumes fv partial molal volumes at infinite dilution fvo , transfer volume fvo (tr), the slop Sv , Gibbs free energy of activation for viscous flow of solution ΔG*1,2 and the B-coefficient have been calculated using Jones-Dole equation. These thermodynamic parameters have been predicted in terms of solute-solute and solute-solvent interaction.
Psoriasis is a chronic inflammatory condition that requires effective treatment. Genetic variability, particularly in the Tumour Necrosis Factor-alpha (TNF-α) gene, may influence patients’ response to biological therapies such as etanercept. This study evaluated the association of four TNF-α gene polymorphisms (rs361525 G/A, rs673 G/A, rs1800629 G/A, and rs1800750 G/A) with serum TNF-α levels and response to etanercept in Iraqi patients with psoriasis. A retrospective study was conducted on 80 patients with moderate-to-severe psoriasis who received etanercept for at least six months. Patients were categorised as responders (≥ 75% PASI reduction) or non-responders (≤ 50% PASI reduction). Genotyping was performed using PCR and
... Show MoreThe research aim at identifying the time of motor response to auditory and visual stimuli as well as identifying the accuracy of blocking and finding the relationship between motor repose time and blocking accuracy. The community was (7) primer soccer league of 2019 – 2020 and the subjects were (24) volleyball players from Al Jaish and Al Shorta clubs ten players from Al Shorta club performed the pilot study. The researchers used the descriptive method and the data was collected and treated using SPSS. The results showed a significant relationship between response time and blocking accuracy. The researchers recommended concentrating on applying scientific principles for developing time of motor response in a manner suitable for bl
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