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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
B Saleem, H Alwan, L Khalid, Journal of Engineering, 2011 - Cited by 2
Antibiotics are essential for treating infectious diseases, but their overuse and adverse effects are raising concerns about global public health. The pervasiveness of antibiotic contamination in aquatic environments has drawn increased attention in recent years. The primary concern regarding the release of antibiotics into the environment is the potential for microorganisms to become resistant to antibiotics. This review article summarizes the analytical methods used to determine the presence of trimethoprim and metronidazole in various environmental samples. These antibiotics have traditionally been analyzed using tandem mass spectrometry or high-performance liquid chromatography coupled to mass spectrometry; fluorescence or ultrav
... Show MoreThis paper compares between the direct and indirect georeferencing techniques in Photogrammetry bases on a simulation model. A flight plan is designed which consists of three strips with nine overlapped images for each strip by a (Canon 500D) digital camera with a resolution of 15 Mega Pixels.
The triangulation computations are carried out by using (ERDAS LPS) software, and the direct measurements are taken directly on the simulated model to substitute using GPS/INS in real case. Two computational tests have been implemented to evaluate the positional accuracy for the whole model and the Root Mean Square Error (RMSE) relating to (30) check points show that th
... Show MoreThe global oil market is one of the most important markets in the world and occupies especially for countries consuming and producing countries, and the status of understanding of the mechanism for determining prices in the market help to stand on many factors affecting oil demand and supply of oil and geopolitical factors, climate and alternative sources of energy .. etc. factors, and that the main objective of the research is to study the causes and results left behind by the oil price shocks in the world market, and the movement of these factors be through a cycle of energy that explain the strength of competition between these factors and their effects on prices, when demand increases evolution Large image leads to significan
... Show MoreThe educational function of television is one of the basic functions in light of the technical development that included the specialized satellite channels in all its fields, including the educational field, as its role became parallel to the role of educational institutions. These studies are among the descriptive studies in terms of the type of study methodology that describes the phenomenon, interprets its and extract the results and relationships between the variables. The study sample was multistage (random and intentional) included the students of the sixth academic and literary preparatory stage in the city of Baghdad.
The study problem was summarized by the following main question:
( What are the motives for the exposure of
The study aims to know the nature of the expected relationship between market share management strategies and the variation in the performance of the shares of a number of Iraqi industrial companies listed in the Iraqi Stock Exchange. For the period (2005-2018) in the light of both the monthly closing prices and sales volume during the research period, the (Panel Data) method was relied on through a stylistic test (fixed effects model and random effects model), and the results determined the need to adopt the fixed effects model method for sample data and test Assumptions, the results showed the positive impact of market share according to its strategies on the performance of stocks according to its studied indicators (Treynor index
... Show MoreSince the beginning of the second decade of the twenty-first century, Saudi Arabia tried to pursue an open foreign policy towards many countries in the Horn of Africa, especially with Ethiopia and Somalia, due to the geostrategic qualities that these two countries possess.Despite the development of Saudi foreign policy towards Ethiopia and Somalia, it was soon affected by the tension after the events that the Gulf states went through, that is, the Qatari crisis with Saudi Arabia,especially after most of the countries of the Horn of Africa adhered to a policy of neutrality towards the Gulf-Gulf crisis.
Thus it is expected that despite the geographical proximity and the historical, economic and political relations between Saudi Ara
... Show MoreThe current study aims to cover the health topics in the Iraqi journalism , to know the concern 's level of the Iraqi journalism when covering the health subjects and to know the size of its performance under the diversity of visual and audio medias. The researcher has discussed his research by wording it with a set of inquiries that should be answered via the research and study. He could have determined that by the following:
What is the concern's level of Iraqi journalism over the health subjects? What are the forms and press arts that are functionalized by the Iraqi journalism as to get the health message to the republics? What is t
... Show MoreProfit is a goal sought by all banks because it brings them income and guarantees them survival and continuity, and on the other hand, facing commitments without financial crisis. Hence the idea of research in his quest to build scientific tools and means that can help bank management in particular, investors, lenders and others to predict financial failure and to detect early financial failures. The research has produced a number of conclusions, the most important of which is that all Islamic banks sample a safe case of financial failure under the Altman model, while according to the Springate model all Islamic banks sample a search for a financial failure except the Islamic Bank of Noor Iraq for Investment and Finance )BINI(. A
... Show MoreThe social networking sites have brought about fundamental changes and a qualitative shift in the marketing industry and its strategies. The Iraqi ministries have used this site i.e. Facebook to spread and disseminate values in order to consolidate it in Iraqi society which has witnessed many changes in all aspects of life.
The researcher studies the pages of both ministries to know the values contained in the publications of the pages of these two ministries, the quality of grooming as well as the forms in which these values are marketed.
The researcher uses a survey method and content analysis for the publications of these two pages during the study period starting from January 1, 2
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