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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
Background: The final stage of endodontic therapy is complete obturation of the root canal system to provide as perfect as possible at the cementodentinal junction of the apical foramen. The purpose of this in vitro study was to evaluate the sealing ability of injection molded thermoplasticized gutta percha and lateral condensation techniques with and without the use of sealers. Materials and Methods: Forty freshly extracted adult human maxillary central incisors with complete formed apices were utilized in this study. The teeth were randomly divided into four groups for evaluation of the apical seal. Group (1) lateral condensation gutta percha technique without sealer, (2) lateral condensation gutta percha technique with sealer, (3) Inject
... Show MoreProvides the style of benchmarking the best possible use whenevaluating the performance and evaluation, as well as improved performance,due to its consistency with the principles of good evaluation of theperformance, an extension of the completion of several functions of the timeand cost less, thereby increasing the efficiency of the management of theinstitutions, especially institutions, the media, as it became public the future ofthe message sender to the same time Zaorosaúl new media is challenging thetraditional media of what distinguishes this new interactive media and mass ledto this transition . However, the media Aljdidhoosaúl traditional mediacontinue to coexist and reinforce each Menhmaalakhr, for his wealth offreedom of opin
... Show MoreThe effects of Internet use on university’s students:The effects of Internet use on university’s students:“A Study on a Sample of Jordanian University’s students "This survey aims to identify the most important effects of Internet use on Jordanian public and private universities’ students by monitoring and analyzing a set of indicators that show the quality of the effects on specific fields such as cultural, social, psychological, moral and political effects .To achieve these goals, the study attempts to answer the following questions:1. What are the effects of Internet’s use on students?2. What is the relationship between the effects and demographic variables such as gender, age, family size an
... Show MoreDAIRMD Professor Hayder R. Al-Hamamy, **Professor Adil A. Noaimi, **Dr. Ihsan A. Al-Turfy, IOSR Journal of Dental and Medical Sciences (IOSR-JDMS), 2015
The current research aims to build a training program for chemistry teachers based on the knowledge economy and its impact on the productive thinking of their students. To achieve the objectives of the research, the following hypothesis was formulated:
There is no statistically significant difference at (0.05) level of significance between the average grades of the students participating in the training program according to the knowledge economy and the average grades of the students who did not participate in the training program in the test of productive thinking. The study sample consisted of (288) second intermediate grade students divided into (152) for the control group
... Show MoreThis study deals with an important area in the field of linguistics, namely person deixis.
The study aims at: (1) Describing the notion of deixis, its importance, and its place in the field
of linguistics, (2) Presenting a detailed illustration of person deixis, and (3) Conducting an
analysis of person deixis in one of Synge‟s plays Riders to The Sea according to Levinson‟s
model. The most important aim of these three is the third one (the analysis). To achieve this
aim, the researcher depends on Levinson‟s (1983) descriptive approach. According to the
descriptive approach of deixis, the category of person deixis can be defined as the encoding of
the participant roles in the speech situation. This encoding is r
The main objective of this research is to find the coefficient of permeability (k) of the soil and especially clayey soil by finding the degree of consolidation (rate of consolidation). New modify procedure is proposed by using the odometer (consolidation) device. The ordinary conventional permeability test usually takes a long time by preparing and by testing and this could cause some problems especially if there is a need to do a large number of this test and there were a limited number of technicians and/or apparatus. From this point of view the importance of this research is clear, since the modified procedure will require a time of 25 minute only. Derivation made to produce an equation which could be used to fined the permeabi
... Show MoreProductivity estimating of ready mixed concrete batch plant is an essential tool for the successful completion of the construction process. It is defined as the output of the system per unit of time. Usually, the actual productivity values of construction equipment in the site are not consistent with the nominal ones. Therefore, it is necessary to make a comprehensive evaluation of the nominal productivity of equipment concerning the effected factors and then re-evaluate them according to the actual values.
In this paper, the forecasting system was employed is an Artificial Intelligence technique (AI). It is represented by Artificial Neural Network (ANN) to establish the predicted model to estimate wet ready mixe
... Show MoreThe radio drama is considered to be one of the arts that is discovered after a long period of theater's discovery. Initially , it was the broad framework of the theater's work when radio was broadcasting the shows on the huge theaters. This beginning encouraged many of the radio specialists to correlate plays with radio and make a novice and distinctive type of art. Thus, radio drama made its first step including the following ( plays, short and long series drama as well as other types of radio arts). Because of the above mentioned , the researcher is stimulating to study directing techniques to process the radio drama script ( Khata'a play as a sample).
The first chapter deals with the
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