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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
To determine the potential of gingival crevicular fluid (GCF) volume, E‐cadherin and total antioxidant capacity (TAC) levels to predict the outcomes of nonsurgical periodontal therapy (NSPT) for periodontitis patients.
NSPT is the gold‐standard treatment for periodontal pockets < 6 mm in depth, however, successful outcomes are not always guaranteed due to several factors. Periodontitis‐associated tissue destruction is evidenced by the increased level of soluble E‐cadherin and reduced antioxidants in oral fluids which could be used as predictors for success/failure of N
Today's smart engineering systems are often faced with situations that are structurally uncertain, informationally incomplete, and non-probabilistically ambiguous, especially for electrical systems. ARDL models are limited in applications in complex computational environments where the uncertainty is due to vagueness, not randomness, and assume the exact parametric representation of the models and the structure of the stochastic uncertainty. This study proposes a new soft-computing paradigm using Fuzzy Autoregressive Distributed Lag (FARDL) models and compares the performance of the Linear Programming (LP) and Quadratic Programming (QP) estimation algorithms using large-scale parallel Monte Carlo simulations to overcome these drawba
... Show MoreThis study is designed to highlight some of the physiological disorders taken place in the renal function, immunological response as well as the ability of the redox system represented by total antioxidant capacity and malondialdehyde levels to combat the toxic exposure of mercuric chloride (HgCl2) with or without collaboration of resveratrol (RES) supplement. Forty-five adult Sprague Dawley, 8-10 weeks old female rats weighing 170-220 g were randomly grouped as following; control group (C) kept without any medication. Dimethyl sulfoxide (DMSO) used as vehicle to prepare RES treatment was given to D-group. RES administered to R-group. Challenge group of rats (HD) was administered HgCl2. The last group of rats (HR) was given HgCl2 with RES i
... Show MoreThis study explores eggshell waste as a low-cost, eco-friendly adsorbent for removing Aniline Blue dye from water. Batch and continuous experiments under various conditions showed effective performance. FTIR and SEM analyses confirmed porosity and functional groups. The adsorption followed the Sips isotherm and pseudo-first-order kinetics. The porous calcium carbonate structure enhanced dye removal. Thermodynamic results indicated an endothermic and spontaneous process. Lower flow rates improved performance in fixed-bed columns. The study supporting environmentally friendly solutions aligned with the Sustainable Development Goals (SDGs).
A polypyrrole‐graphene oxide (PPy/GO) nanocomposite was made chemically using a polymerization method in deep eutectic solvents made up of choline chloride and propionic acid in a 1:2 molar ratio. The purpose of this study is to examine the feasibility and efficacy of PPy/GO nanocomposite in the detection of metronidazole in pharmaceutical formulations utilizing spectrofluorometric techniques. Characterization of the synthesized PPy/GO nanocomposite was conducted using several methods such as transmission electron microscopy (TEM), scanning electron microscopy (SEM), Fourier‐transform infrared spectroscopy (FTIR), thermal gravimetric analysis (TGA), and X
The study aimed to prepare a nanocapsules formulation from the acetonic extract of Moringa oleifera leaves, using polymeric capsules, and test its toxicity against the third instar larvae of Culex pipiens mosquitoes. The leaf extract was prepared using acetone as a solvent, and the nano polymeric capsules were prepared using the synthetic polymer polyethylene glycol 4000. The results showed the successful preparation of nano polymeric capsules from the leaf extract, with an average particle size of 259.2 nm, and a nanocapsule diameter of 263.83 nm, as determined by DLS and SEM analysis, respectively. The toxicity results indicated that the nano polymeric capsules of the leaf extract exhibited higher mortality rates, reaching 97.6% a
... Show MoreThe - mixing ratios of -transitions from levels in populated in the reactions are calculated in present work using - ratio, constant statisticalTensor and least squares fitting methods The results obtained are in general, in good agreement or consistent, within the associated uncertainties, with these reported in Ref.[9],the discrepancies that occurs are due to inaccuracy existing in the experimental data The results obtained in the present work confirm the –method for mixed transitions better than that for pure transition because this method depends only on the experimental data where the second method depends on the pure or those considered to be pure -transitions, the same results occur in – method
A new ligand [ 2-chloro-N- (1,5-dimethyl-3-oxo-2-phenyl-2,3-dihydro -1H-pyrazol- 4- ylcarbamothioyl)acetamide](L) was synthesized by reacting the Chloro acetyl isothiocyanate with 4-aminoantipyrine,The ligand was characterized by(C HNS) elemental microanalysis and the spectral measurements including Uv-Vis ,IR ,1H and13C NMR spectra, some transition metals complex of this ligand were prepared and characterized by Uv-Vis, FT-IR spectra, conductivity measurements, magnetic susceptibility and atomic absorption. From the obtained results the molecular formula of all prepared complexes were [M(L)2(H2O)2]Cl2 (M+2 =Mn, Co, Ni, Cu, Zn, Cd and Hg),the proposed geometrical structure for all complexes were octahedra