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 AryoTrust and Herceptin products were randomly withdrawn from Iraqi hospitals to reflect medicines administered in real clinical settings.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.
the energy that a radiation source emits as light (photons), electromagnetic waves, or particles is known as radiation. X-ray is one type of ionizing radiation that falls within the electromagnetic wave category of short wavelengths. Because of their short wavelength. X-ray is a type of ionizing radiation that is used in a constantly growing number of diagnostic procedures. X-ray diagnostic imaging has been employed in the medical field for more than a century(Hariyoto et al., 2020). Radiation has advantages for human health, but there is also a risk. the impacts of Radiation on Fertility it is an oligospermia, or a reduction in the number of sperm cells, which is already possible after radiation exposure of 0.15 mGy. It Leads to impede
... Show MoreBackground: Pain due to muscular cramp during hemodialysis is one of the most common problems experienced by patient undergoing hemodialysis, and is associated with poor outcomes of patients. The main aim of this study was to comparing the effects of lavender oil and olive oil massage on Pain due to muscular cramp during hemodialysis.
Methods: In this random clinical trial, 60 hemodialysis patients were enrolled randomly and allocated to two groups with 30 members in Lordegan and Brojen hospitals, Shahrekord, Iran. The intervention included flora massage on the lower leg muscles so that the first group received olive oil massage (10 drops) and the second group received lavender oil massage (10 dr
... Show MoreThe Influence of Some Vitamins and Biochemical Parameters on Iraqi Females’ Patients with Malignant Breast Cancer"
Background: Radiation therapy has the ability to destroy healthy cells in addition to cancer cells in the area being treated. However, when radiation combines with doxorubicin, it becomes more effective on breast cancer treatment. Objective: This study aims to clarify the effect of X-ray from LINAC combined with amygdalin and doxorubicin on breast cancer treatment, and the possibility of using amygdalin with X-ray instead of doxorubicin for the breast cancer treatment. Method: Two cell lines were used in this study, the first one was MCF-7 cell line and second one was WRL- 68 normal cell line. These cells were preserved in liquid nitrogen, prepared, developed and tested in the (place). The effect of three x-ray doses combined with a
... Show MoreObjective : The present study is aimed to evaluate the effectiveness of short wave diathermy and
ultrasound therapy for the management of patients with knee osteoarthritis
Methodology : all patients who referred to the Medical Rehabilitation Unit in Baghdad Teaching
Hospital and Sadr A!-Qanat Center. The period of the study was from October 2004 to April 2005, total
number of patients was 24 (9 male and 15 female). Age range of patients was 42-70 years. Complete
clinical and radiological examinations were achieved on all patients and referred to the Medical
Rehabilitation Unit for physiotherapy. Short wave diathermy and ultrasound therapy were applied on
all patients.
Results : Demographic distribution revealed th
Background: Secretory Immunoglobulin A (SIgA) is a subclass of Immunoglobulin A (IgA), It is an antibody that plays an important role in mucosal immunity. It is the main immunoglobulin found in mucous secretions from mammary glands, tear glands and salivary glands, every pathologic process in the body involves the immune system, and periodontal inflammation is one of them and is not an exception. Material and methods: this study was consisted of 60 healthy male participants of an age ranged between (35-50) years old ; 25 of them with generalized moderate chronic periodontists(Clinical Attachment Loss equal to 3-4mm at ≥ 30% of the sites; 20 participants with plaque induced gingivitis and 15 participants had clinically healthy pe
... Show MoreThe physician's commitment to medical insight is affected by several factors that vary from patient to patient in terms of the nature of the disease, the severity of the disease, the age of the patient, and the purpose of undergoing medical intervention. There are circumstances surrounding patients that require the physician to reduce the insight towards them, by concealing medical information. The physician must firmly commit to expanding the scope of his vision to a wider extent than in normal medical work. Therefore, we will discuss in this regard the cases in which medical explanation is reduced and the cases that require confirmation in the following order.