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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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 Cholera epidemic model is proposed and studied analytically as well as numerically. It is assumed that the disease is transmitted by contact with Vibrio cholerae and infected person according to dose-response function. However, the saturated treatment function is used to describe the recovery process. Moreover, the vaccine against the disease is assumed to be utterly ineffective. The existence, uniqueness and boundedness of the solution of the proposed model are discussed. All possible equilibrium points and the basic reproduction number are determined. The local stability and persistence conditions are established. Lyapunov method and the second additive compound matrix are used to study the global stability of the system.
... Show MoreIn this paper a system is designed on an FPGA using a Nios II soft-core processor, to detect the colour of a specific surface and moving a robot arm accordingly. The surface being detected is bounded by a starting mark and an ending mark, to define the region of interest. The surface is also divided into sections as rows and columns and each section can have any colour. Such a system has so many uses like for example warehouses or even in stores where their storing areas can be divided to sections and each section is coloured and a robot arm collects objects from these sections according to the section’s colour also the robot arm can organize objects in sections according to the section’s colour.
The main aim of the research is to identify the impact of the application of IFRS for SMEs on optimizing the utility of information for financial reports. To answer the questions and test the hypotheses of the research, researchers relied on the descriptive analytical approach. First, the researchers clarified the theoretical aspect through previous studies, and then they analyses d the results of the applied study by testing the hypothesis using the SPSS.
A questionnaire was distributed after evaluation and arbitration by a number of specialists on selected sample. The sample of 120 respondents consists of general managers, department directors, head of departments, accountants, auditors and financial controllers working in the
... Show MorePurpose: To determine the effect of information technology governance (ITG) under the control objectives for information and related technologies (COBIT) on financial performance is the objective of this study. Additionally, the article seeks to look into the relationships between the factors under consideration. Theoretical framework: Information technology and operational processes are evaluated and ensure their compliance with the instructions of the Central Bank of Iraq. Therefore, the research dealt with a conceptual framework by reviewing the literature on the importance of the COBIT framework in assessing financial performance. Design/methodology/approach: To investigate the effect of information technology; we the valu
... Show MoreThis study aimed to explain the criteria of managers at different levels of nursing in selecting effective nursing diagnosis.
In conventional content analysis, 10 nursing managers at different levels including head nurse, supervisor, and nursing manager were interviewed. Data was collected with semi-structured interviews and a narrative approach. Data analysis was performed using the Zhang–Wildemuth method simultaneously with sampling.
An epidemiological study in Al-Mahmmodiya (50 km south Baghdad) to investigate a possible vector of Leishmaniasis were applied .This region is considered as a foci of Leishmaniasisaccording to the health association statistics. CDC light traps were used to collect the insects nightly. Insects were collected by Indoor application as human dwellings and animal shelters and Outdoor application as rodent's barrows and field trees. Sand flies were transported to the laboratory, isolated and identified according to the identification keys in Tropical Biological Researches Unit at the Collage of Science / University of Baghdad. Must of the collected sand flies were belonging to three species PhlebotomuspapatasiScopoli(45%), PhlebotomusalexandriSin
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