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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
Abstract
The current research aims to identify the level of partnership between school and community agencies to improve secondary school outcomes for students with intellectual disabilities and develop strategies that help enhance community partnerships between schools and agencies. The researcher used the qualitative research approach; he utilized the interviews as a tool for data collection. The sample of research included (12) participants: three female school leaders, three male-school leaders, three female-school supervisors, and three male-school supervisors in schools that have programs for students with intellectual disabilities in Riyadh. The results of the study showed that the level of partnership bet
... Show MoreConcurrently with the technological development that the world is witnessing the crime of money laundering to evolve faster and with multiple methods and its economic, political and social impacts raised increasingly. And for phenomenon dangerous the international community in recent years is keen to be considered combating money laundering as a general indication whereby verification of the international response the stats and its banks and financial institutions with international requirements mandated in this aspect, so the increasing interest the governments of countries in the laws and procedures that contribute to the reduction of the phenomenon of money laundering and avoid legislation economy and the banking and financial sectors
... Show MoreCoronary heart disease (CHD) is the leading cause of death in United State (U.S.). Controlling of modifiable risk factors such as smoking, hypertension (HT), diabetes mellitus (D.M.), dyslipidemia, physical inactivity & obesity will prevent other serious cardiovascular complications
Support vector machines (SVMs) are supervised learning models that analyze data for classification or regression. For classification, SVM is widely used by selecting an optimal hyperplane that separates two classes. SVM has very good accuracy and extremally robust comparing with some other classification methods such as logistics linear regression, random forest, k-nearest neighbor and naïve model. However, working with large datasets can cause many problems such as time-consuming and inefficient results. In this paper, the SVM has been modified by using a stochastic Gradient descent process. The modified method, stochastic gradient descent SVM (SGD-SVM), checked by using two simulation datasets. Since the classification of different ca
... Show MoreThe picture has taken a place that sometimes enables it to take precedence over media analysis، psychology، and political communication.
The image has the ability to influence to obtain persuasion، not only emotionally or
dramatically، but also on the level of commercial and political persuasion. In every
image، the intention of that persuasion is hidden.
It can be identified by a set of underlying dimensions such as vitality، social dominance، and confidence، for which a group of specific suggestions or movements، such
as a smile، the movement of hands، or the nature and way of looking with the eyes، is
established. The visual image often precedes its verbal counterpart in the proce
Purpose: As managers can lead a set of ways to improve internal communication in public organizations, and leadership can cultivate a common understanding of goals within the organization and share the vision in preparation for its way to better performance, the purpose of the research is to assess the type and strength of the relationship between internal communication and different forms of leadership. Theoretical framework: The study demonstrates how leaders in public organizations improve internal communication, related to employees' perceptions of public organizations' routines and performance. Design/methodology/approach: The study uses the ordinary least squares (OLS) and applied multiple regression A sa
... Show MorePropaganda speech in the Gulf press articles about the Qatari crisis, an analytical study in the political articles published in the newspapers (Riyadh) Saudi Arabia and (Al-Ittihad) UAE from 5/6/2017 to 5/9/2017, University of Baghdad, College of Media, Press Department, 2019. The problem of the research was to monitor the contents of propaganda messages to Saudi Arabia and the UAE regarding the Qatari crisis, especially with the escalation of propaganda media campaigns between the four boycotting countries on the one hand and Qatar on the other hand, in light of crises and conflicts in the Gulf region and the Arab region in general. The researcher used the survey method to answer the research questions and achieve its results. This res
... Show More“Child of today is a man of the future" this slogan is one of the most popular logos of international organizations and institutions that dealing with human beings needs in general and children needs in particular, whether these needs are educational, health, social, or economic. Children require special care and extra legal protection, since the child-raising is not the Child’s own issue, but it's the issue of the society in which he/she would integrate.
As the education and language skillsacquisition primarily associated with hearing, because human being receives most of the skills and knowledge through the hearing; that imitate sounds and learn how to speak isacquired only by hearing, so therefore the hearing - impairedchi
... Show MoreLeuciscidae species are the abundant and widely distributed fish species in Iraq's inland waters. They are complex species, and morphology makes them difficult to identify. Molecular analysis achieved and confirmed the morphological characters. Twenty specimens of Acanthobrama marmid were collected from two localities at Tigris River, in the middle of Iraq; 15 specimens from the Al-Zubaydia sub-district and five specimens from Al-Tharthar Lake. We used the mitochondrial DNA cytochrome b (cytb) gene to sequence the DNA of A. marmid. The following analysis are compared the sequences with those of other fish genera and species found in the Gene Bank. The barcoding result (DNA sequencing) in fishes found in the same family (Leuciscidae) showed
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