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Analytical Physicochemical and Functional Studies to Compare AryoTrust, a Follow-On Biologics, with the Originator Trastuzumab (Herceptin)
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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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.

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Publication Date
Thu Oct 02 2014
Journal Name
J. Med. Chem. Sci
Design, Synthesis, Spectral Characterization, and Study of Biological Effect of Novel azobenzen-p,p'-di(2-amine-1,3,4- thiadiazol-5-yl) Derivatives
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The compound azobenzen-p,p'-di(2-amine-1,3,4-thiadiazol-5-yl) (A) was formed by reacting 4,4'-(diazene-1,2-diyl)-dibenzoyl chloride with thiosemicarbazide. Ten substituted amino derivatives of azobenzen-p,p'-di(2- amine-1,3,4-thiadiazol-5-yl) were synthesized by reaction of compound (A) with formaldehyde and acetaldehyde to give Schiff base. The compound (A) reaction with sodiumcyanat and potassiumisothiocyanat gave uredo and thiouredo-1,3,4-thiadizol-5-yl. However, its reaction with benzenesulphonyl chloride and 4-methyl benzene sulphonyl chloride gave sulphonamido compounds, while its reaction with acetylchloride and benzoyl chloride gave acetamido and benzamido derivatives. Its reaction with succinic and glutaric acid gave succinamido an

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Publication Date
Thu Jan 01 2026
Journal Name
Tropical Journal Of Pharmaceutical Research
Pharmacodynamic biomarker of CDK4/6 inhibition: prospective evaluation of serum Cyclin D1, CDK4, and CDK6 in palbociclib-letrozole-treated metastatic breast cancer
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Purpose: To evaluate the usefulness of serum cyclin D1, CDK4, and CDK6 as biomarkers of treatment response and progression-free survival (PFS) in metastatic breast cancer (MBC). Methods: In a single-center prospective observational study, 74 women with hormone-receptor-positive (HR+)/ human epidermal growth receptor-2 (HER2)-negative metastatic breast cancer were recruited from the Oncology Hospital, Medical City in Baghdad, Iraq. The patients were treated with oral Palbociclib (125 mg) for 21 days, then continued with Letrozole (2.5 mg) for 7 days, and completed six treatment cycles. The candidates were divided into two groups based on therapeutic response: Group 1 responded to the palbociclib plus letrozole combination therapy, a

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Publication Date
Fri Nov 20 2015
Journal Name
Iraqi Journal Of Science
New Approach for Determination of Oxonium Ion in Inorganic Acids by Quenched Fluorescence of Analytically Interested Species via the Liberated Bromine Using Continuous Flow Injection Laser Diode Fluorimeter Analyser
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A new method is characterized by simplicity, accuracy and speed for determination of Oxonuim ion in ionisable inorganic acid such as hydrochloric (0.1 - 10) ,Sulphuric ( 0.1 - 6 ),nitric ( 0.1 - 10 ), perchloric ( 0.1 - 7 ), acetic (0.1 - 100 ) and phosphoric ( 0.1 - 30 ) ( mMol.L-1 )acids. By continuous flow injection analysis. The proposed method was based on generation of bromine from the Bro-3-Br-- H3O+. Bromine reacts with fluorescein to quenches the fluorescence . A sample volume no.1 (31μl) and no.2 (35μl) were used with flow rate of 0.95 mL.min-1 using H2O line no.1as carrier stream and 1.3 mL.min-1 using fluorescein sodium salt line no.2. Linear regression of the concentration ( mMol.L-1 ) Vs quenched fluorescence gives a correla

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Publication Date
Wed Sep 20 2006
Journal Name
00
INVESTIGATING SOME OF THE SYNTACTIC ERRORS MADE BY EFL COLLEGE STUDENTS IN WRITTEN ENGLISH EXPRESSIONS استقصاء بعض الاخطاء النحوية لطلبة الكلية دارسي اللغة الانكليزية لغة اجنبية في التعابير الانشائية
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Publication Date
Sun Feb 03 2019
Journal Name
Journal Of The College Of Education For Women
Shaikh Al-Fadhali's Thesis in Parsing the phrase 'No god but Allah' written by Al-Shaikh Saif-el-Deen Atta Abu-el Futouh Al-Wafa'y Al- Fadhali (1020 A.D.)
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Abstract
Praise be to Allah, The Lord of the worlds, and peace be upon
Muhammad the master of former and latter people, and peace be upon His
relatives, companions and those who followed Him to Judgment day.
After recognizing the prescription which is called (Al- Fadhaly's Thesis in
parsing of "There is no god but God") as it is related with the word of the
investigation of this issue attracted me, as being related with the idea of the
only one God that is mentioned in the prophetic speech, which is said by
Anas- God satisfies him- Who said, Said the Messenger Muhammad peace
be upon him " Goes out of the Hell who said: there is no god but God, and in
his heart a hair weight of charity, and goes out of the He

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Publication Date
Fri Jun 01 2018
Journal Name
Journal Of The College Of Languages (jcl)
ЯВЛЕНИЯ ПОЛИСЕМИИ И ОМОНИМИИ В СПЕЦИАЛИЗИРОВАННОЙ ТЕРМИНОСИСТЕМЕ (на материале геодезической терминологии) Homonymy and Polysemy in Technical Terminology: Terms of Geodesy as an Example
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Aннотация

В статье представлены явления полисемии и омонимии в специализированной терминосистеме, а именно в геодезической терминологии; определены предпосылки и причины возникновения полисемии и омонимии в профессиональном языке в области геодезии и кадастра; установлены различия и взаимосвязь между понятиями омонимия и полисемия; выделены главных типы полисемантических тер

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Publication Date
Thu Nov 01 2012
Journal Name
Iraqi Postgraduate Medical Journal
Lactic Acid 5% Mouthwash is an Effective Therapeutic and Prophylactic Agent in Treatment of Recurrent Aphthous Ulcer (Single blind placebo controlled therapeutic study)
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KE Sharquie, SA Al Mashhadani, AA Noaimi, RK Al-Hayani, SA Shubber, Iraqi Postgraduate Medical Journal, 2012 - Cited by 1

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Publication Date
Wed Nov 01 2017
Journal Name
Iraqi Journal Of Community Medicine
Zinc Sulphate 5% Mouthwash is an Effective Therapeutic and Prophylactic Agent in Treatment of Recurrent Aphthous Ulcer (Single blind placebo controlled therapeutic study).
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KE Sharquie, SA Al-Mashhadani, A A Noaimi, RK Al-Hayani, SA Shubber, Iraqi Journal of Community Medicine, 2017 - Cited by 1

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Publication Date
Wed Oct 26 2022
Journal Name
Research Journal Of Chemistry And Environment
Synthesis, Antioxidant ability and Docking study for new 4, 4'-((2-(Aryl)-1H-benzo [d] imidazole-1, 3 (2H)-diyl) bis (methylene)) diphenol
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New series of 4,4'-((2-(Aryl)-1H-benzo[d]imidazole1,3(2H)-diyl)bis(methylene))Diphenol(3a-g) was successfully synthesized from cyclization of the reduction product of bis Schiff bases (2) with aryl aldehydes bearing phenolic hydroxyl in the presence of acetic acid. The structure of these compounds was identified from FT-IR, 1H NMR, 13C NMR and EIMs. The Antioxidant capability was screened by DPPH and FRAP assays. Both assays showed antioxidant capability more than BHT as well. Compounds 3b and 3c showed antioxidant capacity slightly less than ascorbic acid. The docking study for theses compound was carried out as III DNA polymerase inhibitor. The results of docking demonstrated that the increase in hinderances around phenolic hy

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Publication Date
Mon May 01 2017
Journal Name
The Journal Of Immunology
Attenuation of Staphylococcal enterotoxin-B (SEB)-induced lung injury (ALI) by resveratrol results from miR-193a down-regulation and alterations in metabolic profile
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Abstract<p>Resveratrol, (RES), a phytoalexin, is well-known for its anti-inflammatory and anti-oxidant properties. SEB, a superantigen, is known to trigger ALI and cause mortality. In the current study, we tested the effect of RES in a dual-dose model of SEB exposure that triggers ALI and causes 100% mortality in C3H/HeJ-mice. The data revealed RES attenuated SEB-induced ALI and prevented mortality. Forty eight hours post-SEB exposure, lung-infiltrating mononuclear cells were tested for microRNA expression profile to determine the epigenetic regulation by resveratrol. SEB-activated splenocytes were pre-treated with 50 μM of RES or vehicle for metabolic profile analysis by measuring oxygen consu</p> ... Show More
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