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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
A cumulative review with a systematic approach aimed to provide a comparison of studies’ investigating the possible impact of the active form of vitamin D3, calcitriol (CTL), on the tooth movement caused by orthodontic forces (OTM) by evaluating the quality of evidence, based on collating current data from animal model studies, in vivo cell culture studies, and human clinical trials. Methods: A strict systematic review protocol was applied following the application of the International Prospective Register of Systematic Reviews (PROSPERO). A structured search strategy, including main keywords, was defined during detailed search with the application of electronic database systems: Medline/Pubmed, EMBASE, Scopus, Web of Science, and
... Show MoreThis study investigates the Linguistic and Conceptual equivalence of Conner’s Revised Scales when applied on a Sudanese sample. Sudanese parents and teachers completed behavior-rating scales on a stratified sample of 200 children. These instruments were based on Conner’s parent -48 and teacher-28 questionnaires. Following a reliable translation into Sudanese Arabic the test-retest reliability of the items and the internal consistency of the original Conner’s' revised scales were explored. The associations between scale scores and between parents and teachers scores were also examined. Both instruments displayed good reliability and the original Conners scales had satisfactory internal consistency. The inter-correlation sugg
... Show MoreThe determiner phrase is a syntactic category that appears inside the noun phrase and makes it definite or indefinite or quantifies it. The present study has found wide parametric differences between the English and Arabic determiner phrases in terms of the inflectional features, the syntactic distribution of determiners and the word order of the determiner phrase itself. In English, the determiner phrase generally precedes the head noun or its premodifying adjectival phrase, with very few exceptions where some determiners may appear after the head noun. In Arabic, parts of the determiner phrase precede the head noun and parts of it must appear after the head noun or after its postmodifying adjectival phrase creating a discontinu
... Show MoreEssential approaches involving photons are among the most common uses of parallel optical computation due to their recent invention, ease of production, and low cost. As a result, most researchers have concentrated their efforts on it. The Basic Arithmetic Unit BAU is built using a three-step approach that uses optical gates with three states to configure the circuitry for addition, subtraction, and multiplication. This is a new optical computing method based on the usage of a radix of (2): a binary number with a signed-digit (BSD) system that includes the numbers -1, 0, and 1. Light with horizontal polarization (LHP) (↔), light with no intensity (LNI) (⥀), and light with vertical polarization (LVP) (↨) is represen
... Show More<p>The current work investigated the combustion efficiency of biodiesel engines under diverse ratios of compression (15.5, 16.5, 17.5, and 18.5) and different biodiesel fuels produced from apricot oil, papaya oil, sunflower oil, and tomato seed oil. The combustion process of the biodiesel fuel inside the engine was simulated utilizing ANSYS Fluent v16 (CFD). On AV1 diesel engines (Kirloskar), numerical simulations were conducted at 1500 rpm. The outcomes of the simulation demonstrated that increasing the compression ratio (CR) led to increased peak temperature and pressures in the combustion chamber, as well as elevated levels of CO<sub>2</sub> and NO mass fractions and decreased CO emission values un
... Show MoreIn this study, the optical and thermal performance of a Parabolic Trough Collector PTC system is investigated theoretically. A series of numerical simulations and theoretical analysis has been conducted to investigate the effect of the receiver geometry and location relative to the focal line on its optical performance. The examined receiver geometries are circular, square, triangular, elliptical and a new design of circular‐ square named as channel receiver. The thermal performance of PTC is studied for different flow rates from (0.27 to 0.6 lpm) theoretically. Results showed that the best optical design is the channel receiver with an optical efficiency of 84% while the worst is the elliptical
In a report by Transparency Organization in 2010, Iraq has 200 newspapers, magazines, sixty-seven radio stations and 45 satellite TV channels. The increase in these figures is measured in days or weeks and not months and years. This fact confirms the importance of studying content providers, especially youth sports content, for two reasons: the first is that young people constitute the highest percentage in Iraqi society, with all the potential involved in shaping the future aspects; the second reason is that for years sport has become an important pillar in people's lives not only in the entertainment aspect as it was seen in the past; Rather, sport has an influential presence in politi
... Show MoreThe current study introduces a novel technique to handle electrochemical localized corrosion in certain limited regions rather than applying comprehensive cathodic protection (CP) treatment. An impressed current cathodic protection cell (ICCPC) was fabricated and firmly installed on the middle of a steel structure surface to deter localized corrosion in fixed or mobile steel structures. The designed ICCPC comprises three essential parts: an anode, a cathode, and an artificial electrolyte. The latter was developed to mimic the function of the natural electrolyte in CP. A proportional-integrated-derivative (PID) controller was designed to stabilize this potential below the ICCPC at a cathodic potential of −850 mV, which is crucial for prote
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