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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
Praise be to God, and may blessings and peace be upon the Messenger of God, his family and companions, and from his family and after ...
It is the right of every nation to be proud of its heritage, science and civilization among the nations, taking pride in the efforts of its construction and the keenness of its scholars and dedication to serve their nation and their history, and from the great sciences that boast and honor our great nation and distinguish it over others the science of attribution and the preservation of the novel over generations and ages. The novel is preserved from the plagiarism of the nullified, the excess of the deceitful and the liars, and the science of isnad from religion as the scholars said, and without the
The nay is one of the important in stvument in Arabic music which is considered one of the oriental instruments used in the oriental music tect, and is also considered one of the basic instruments in Arabic music, It is used in many religious and mundane areas, through its expressive capabilities through which expression and conveyance of feelings to the recipient, despite their importance and role in music, and through the researcher's follow-up to this subject did not find a study on the potential capabilities of the machine. In view of the above, and given the importance of this subject at the researcher, the need arose for research to study (the potential of the flute machine)..
This experiment was conducted to examine the effects of injected gibberellic acid GA3 in subcutaneous of hens neck and supplemental vitamin D3 to control basal diet on productive performance and egg shell thickness ,relative weight of egg shell of aged laying hens. Two hundred and seventy Lohmann Brown laying hens at 73 weeks of age were randomly assigned to three treatments groups. Each treatment consist of three replicates (30 hens / replicate). The treatments were : T1 control were injected subcutaneous with 0.2 ml / kg of body weight of ethanol: sesame oil solution, T2 and T3 were injected subcutaneous with 0.2 ml / kg of body weight of ethanol: sesame oil solution which contained 400 μg GA3/ kg of body weight /week during 8 weeks (tre
... Show MoreA theoretical study including the effects of the fusion characteristics parameters on the fundamental fusion rate for the BEC state in D-D fusion reaction is deal with varieties physical parameters such as the fuels density, fuel temperature and the astrophysics S-factor are processed to bring an approximately a comparable results to agree with the others previously studies.
synthesis and characterization of New schiff base Ligand Derived from 4-amino anti pyrine and it's complexes with some Metal lons and theirAntibacterial studies
Three hundred samples of washing water of vegetables were collected from women aged ( 15- 6o) years from different area in Baghdad governorate and its suburbs include two rural area ( Jaddria in Baghdad university and Al –Wagif in Rashdia) and two urbane area (Mansoure and Escan) . The samples were examined by precipitation method and then by staining method ( Lugols –Iodine stain) . The percentage of infection of intestinal parasites 36.3% include 15.3% for urban area and 57.3% in rural area and a significant difference was found between those groups . .The results showed also increased in the prevalence of parasitic infection in group age (15 -30) year .Also the results showed only 109 sample infected with eight specie
... Show MoreThe goal of this study is to investigate the relationship between the student and the teacher and the student's behavior for a subject of the student in the intermediate stage, the sample contained (568) student, (266) male and (302) female.
The scale of student – teacher relationship was built according to a questionnaire pointed to a sample of the students, adding to that reviewing a number of previous scales and studies which was about the same topic, and in the same way a measure of student behavior was constructed.
Results showed that there was significant relation between the student's teacher relationship and student behavior, and the level of student- teacher relationship is higher than the average of the population that
I noticed a researcher while working in the kindergarten that there is a group of
parameters resort to the use of different methods may be some undesirable and some
undesirable So felt researcher detection methods used parameters Riyadh in the face of the
pressures of life, being engaged in kindergarten eligibility, governmental or being married or
unmarried, as well as educational attainment for this parameter.
To achieve the objectives of the research: -
The researcher prepare a scale methods face the pressures of life of the parameters
have been confirmed the veracity of the paragraphs of the scale of the presentation to a group
of experts in this area, and extracted power discriminatory clauses scale and extra
The research aims to identify the effect of the training program that is based on integrating futuristic thinking skills with classroom interaction patterns on mathematics teachers in order to provide their students with creative solution skills. The research sample consisted of 31teachers (15 teachers for the experimental group and 16 for the control groups). The researcher developed a measure for the academic self-efficacy consisting of (39) items. Its validity, reliability, coefficient of difficulty and discriminatory power were estimated. To analyze the findings, the researcher adopted the Mann-Whitney (U) test and the effect size, and the findings were as follows: There is a statistically significant difference at the significance leve
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