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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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 MoreThe 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
Commercial graphite (CGT) powder was used as an adsorbent surface for cationic dye, Janus green (JG), from aqueous solutions. This study aims to highlight the practical significance of using inexpensive CGT as an efficient adsorbent for the removal of JG dye from industrial wastewater. CGT was characterized by Fourier transform infrared spectroscopy, scanning electron microscopy, and X-ray diffraction. The adsorption process was investigated by examining parameters like the weight of the adsorbent, contact time, and temperature. Pseudo-second-order kinetic (PSO), pseudo-first-order, and intraparticle diffusion were used for analyzing the kinetic data. JG dye's adsorption kinetics fit the PSO kinetic model well (R2= 0.999). Furthermo
... Show MoreBackground: The demand for esthetic orthodontic appliances is increasing; so the esthetic orthodontic archwires were introduced. Among them, Teflon and Epoxy coated stainless steel archwires. The amount of force available from the archwire depends on the structural properties and susceptibility to corrosion. All metallic alloys are changed during immersion in artificial saliva, chlorhexidine mouthwash andtoothpaste, but their behaviors differ from one type to another. They corrode at different rates, which lead to decrease the amount of force applied to the teeth. This in vitro study was designed to evaluate the corrosion pits in stainless steel archwires coated with Teflon and with Epoxy in dry and after immersion in artificial saliva, chl
... Show MoreIn this work, the preparation of new multidentate Schiff-base lig and and its metal complexes are described. The formation of the lig and{ 2,2`((5-methyl-1,3-phenylene)-bis-(oxy))-bis-N`(E`)-2- hydroxybenzylideneacetohydrazide}[H2L] was prepared from the reaction {2,2-((5-methyl-1,3-phenylene)-bis-(oxy))- di-(acetohydrazide)}[M]precursor and salicylaldehyde in a 1:2 mole ratio, respectively. The reaction of the lig and [H2L] with (Cr+3 , Mn+2 and Fe+2 )metal ions in a 1:2 (L:M) mole ratio. Ligand and complexes were characterised via spectroscopic analyses; [FT-IR, UV-Vis spectroscopy,(C.H.N) microanalysis, chloride content, thermal analysis(TG), electrospray mass, magnetic susceptibility and conductivity measurements. The characterisation d
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