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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
In this paper, a new hybrid algorithm for linear programming model based on Aggregate production planning problems is proposed. The new hybrid algorithm of a simulated annealing (SA) and particle swarm optimization (PSO) algorithms. PSO algorithm employed for a good balance between exploration and exploitation in SA in order to be effective and efficient (speed and quality) for solving linear programming model. Finding results show that the proposed approach is achieving within a reasonable computational time comparing with PSO and SA algorithms.
Objective This study aimed to evaluate the effects of disinfectant solutions, namely, the alcoholic extract of Salvadora persica L. (A1 = 10% and A2 = 15%) and chlorhexidine digluconate (A3 = 2%), on the tear strength and hardness of room temperature vulcanizing (RTV) VST50F and heat temperature vulcanizing (HTV) Cosmesil M511 silicone elastomers before and after reinforcement with nanofillers (TiO2) and intrinsic pigment. Materials and Methods: A total of 320 specimens were prepared, with 160 specimens each for RTV and HTV silicone. Forty specimens were evaluated before disinfection and divided into two equal groups, namely, control (without additive) and experimental (with ad
Statistical methods of forecasting have applied with the intention of constructing a model to predict the number of the old aged people in retirement homes in Iraq. They were based on the monthly data of old aged people in Baghdad and the governorates except for the Kurdistan region from 2016 to 2019. Using Box-Jenkins methodology, the stationarity of the series was examined. The appropriate model order was determined, the parameters were estimated, the significance was tested, adequacy of the model was checked, and then the best model of prediction was used. The best model for forecasting according to criteria of (Normalized BIC, MAPE, RMSE) is ARIMA (0, 1, 2).
The study examines the religious references of the art of miniatures in the Iranian school "Bahzad model" completed in Iran during the twelfth century AH, according to the controls and characteristics of the authoritative references. The researcher presented the problem of research, its importance, the need for it and its purpose, defined the terms in the research. The theoretical framework came with three investigations. The first topic of the concept of the reference in the field of knowledge, which concluded the most important features of the reference, is that each symbolic existence corresponds to a real existence and symbolic presence is an input to the realization of the reference. The reference then becomes a sign that acts as a
... Show MoreBackground: Saliva is a specific bio-fluid with important biomarkers. Analyzing any alternation in these markers could give valuable information, in relation to oral health status parameters. The aim of this study was to investigate the level of α -amylase in unstimulated whole saliva of healthy, primary school children in relation to some oral health parameters. Materials and Methods: A questionnaires consisted of demography and medical histories of participants were filled by children families. Saliva samples were collected for 5- minutes between 9:00 -11:00 AM from 114 healthy students aged 6-13 years, divided into four age groups. Flow- rate, Plaque and Gingival Index were assessed and dentition status was investigated by DMFT/dmft
... Show MoreThis study provides valuable information on secondary microbial infections in H1N1 patients compared to Seasonal Influenza in Iraqi Patients. Nasopharynx swabs were collected from (12 ) patients infected with Seasonal influenza (11 from Baghdad and 1 Patient from south of Iraq) ,and ( 22 ) samples from patients with 2009 H1N1 ( 20 from Baghdad and 2 from south of Iraq). The results show that the patients infected with 2009 H1N1 Virus were younger than healthy subjects and those infected with seasonal influenza. And the difference reached to the level of significance (p< 0.01) compared with healthy subjects.Two cases infected with 2009 H1N1 virus (9.1%) were fro
... Show MoreThis research discussed and analyzed the formulation of a strategy to manage tax compliance risks, as an applied research in the General commission for Taxes. The questionnaire was used as a research tool to identify the factors that stimulate or retard the research sample from being compliant. The K-means clustering method was also used to enable the classification of the research sample's views into four behaviors, some of these views pose tax-compliance risks. The research concluded that risk management is a continuous process and that all departments of the General commission for Taxes are responsible for its implementation to enable them to deal with the behavior of the taxpayer towards tax compliance. And it recommended
... Show MoreThe paper examines key aspects of the use of phraseologi-cal units related to colors in Russian culture and speech. It explores their role in shaping cultural identity, reflecting national characteristics and men-tality. The study analyzes the frequency and contexts of the use of color-related phraseological units in contemporary speech, as well as the influ-ence of media and literature on their popularization. The author highlights the significance of phraseological units in preserving cultural heritage and fostering a deeper understanding of language and culture.
Statistical methods of forecasting have applied with the intention of constructing a model to predict the number of the old aged people in retirement homes in Iraq. They were based on the monthly data of old aged people in Baghdad and the governorates except for the Kurdistan region from 2016 to 2019. Using BoxJenkins methodology, the stationarity of the series was examined. The appropriate model order was determined, the parameters were estimated, the significance was tested, adequacy of the model was checked, and then the best model of prediction was used. The best model for forecasting according to criteria of (Normalized BIC, MAPE, RMSE) is ARIMA (0, 1, 2)