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Safety Profile of Biological Drugs in Clinical Practice: A Retrospective Pharmacovigilance Study
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Biological drugs have an active substance that is made by a living organism or derived from a living organism. They are one of the important therapy options used in a wide range of diseases especially life-threatening diseases. Biological therapy opens new opportunities for treating different diseases for which drug therapy is minimal, but they have considerable differences in the safety consequences in comparison with non-biological drugs. The aim of the current study was to assess the post-marketing safety profile of biological drugs used in Iraqi hospitals by the analysis of the reported adverse drug reactions regarding their severity, seriousness, preventability, expectedness, and outcome. It is a retrospective study of the individual case safety reports from the Iraqi Pharmacovigilance Center/Ministry of Health. There were 446 individual case safety reports in the research, involving 899 adverse drug reactions. Rituximab was found to be the drug with the highest number of adverse drug reactions with 241 adverse drug reactions (26.81% out of total adverse drug reactions). Most of the adverse drug reactions were related to general disorders and administration site conditions (22.25%). Regarding severity of adverse drug reactions, the majority of adverse drug reactions were observed in moderate levels [Level 4 (26%), and Level 3 (18%)]. The severe adverse drug reactions in patients below 18 years age group were significantly higher compared to adults and elderly. Seriousness assessment showed that the majority of adverse drug reactions were serious (52%). Rituximab was the drug for which the highest number of serious adverse drug reactions was reported (41.28% of total serious adverse drug reactions), Most of the adverse drug reactions (66%) were probably preventable. Fatality outcome was reported for 3% of adverse drug reactions while 43% of adverse drug reactions were recovered/resolved.

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Publication Date
Sat Jan 24 2026
Journal Name
Journal Of Baghdad College Of Dentistry
The effect of different oral hygiene regimens on the quantity of cariogenic plaque on orthodontic bands with different attachments (A clinical photographic study)
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Background: Fixed orthodontic appliances impede the maintenance of oral hygiene and result in plaque accumulation leads to enamel demineralization caused by acids produced by bacteria. Studies on plaque control strategies in orthodontic populations are limited. This might be caused by difficulties in the quantitative evaluation of dental plaque because the teeth have various levels of bracket coverage, and different tooth sizes and malocclusions, making the traditional categorical indices complex. The present study aims to evaluate the effect of different hygiene protocols on plaque quantity on bands with different attachments. Materials and method: Twenty patients had four bands within the orthodontic appliance. Then randomly divided into

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Publication Date
Mon Jun 15 2020
Journal Name
Journal Of Baghdad College Of Dentistry
Evaluation of dental enamel color after fixed orthodontic therapy using two types of protectors to prevent white spot lesions (A prospective clinical study)
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Background: The aim of this study is to evaluate the color change ∆E of the dental enamel following treatment with 2 kinds of protector (icon infiltrant, clinpro varnish) before fixed orthodontic treatment to avoid the possible white spot lesions. Materials and Methods: Fifty four subjects treated with fixed appliances were divided into 3 groups: the 1st group was control, while the 2nd and 3rd groups were treated with icon infiltrant and clinpro varnish before bonding procedure, respectively. Color parameters (L,a,b) were recorded for the middle and gingival thirds before and after bonding procedure to get the ∆E of each group. Results: One-way ANOVA test showed a non-significant difference in ∆E between the 3 groups a

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Publication Date
Sun Sep 01 2013
Journal Name
Baghdad Science Journal
Kinetic Study of the Hydrolysis of synthesized Ibuprofen Ester and its Biological Activity
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It is known that the oral administration of ibuprofen caused an irritation of stomach as a side effect due to its carboxylic moiety. Ibuprofen ester was synthesized by linking the carboxylic moiety of ibuprofen and the hydroxylic group of paracetamol to reduce its side effect. Study the kinetic hydrolysis of prepared ester was examined at different values of physiological pH (1.0, 5.8, 6.4 and 7.4) at 37 ± 0.1 of 1 hour period. Measurements of absorbance were carried out by UV-Visible spectrophotometer to follow the stability of ester, it showed Pseudo first order hydrolysis. The pH- apparent rate profiles of ester was exhibited a good stability at pH 1.0 and pH 5.8. Pharmacological activity in vivo of prepared ester was evaluated in re

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Publication Date
Sun Dec 22 2019
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Evaluation of Knowledge, Attitudes and Experience of off-label Drug Prescribing Practice among Physicians in Baghdad City Hospitals
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Abstract

The present study aims to assess the knowledge, attitude, and experience of off-label prescribing practice among physicians in Baghdad city hospitals. This cross-sectional study was performed through the period from November 1st 2018 to March 2019 at 17 hospitals, a self-administered questionnaire was utilized to collect data from the physicians, and the targeted hospitals were randomly selected at different regions in Baghdad City area. Out of the 400 distributed questionnaires to the physicians, 383 of them were returned completed, 57.2% indicated that they were reasonably familiar with the term “off label drug”, 57.7% mentioned that the most common medical reasons for the prescribing o

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Publication Date
Mon Oct 17 2022
Journal Name
Journal Of The Faculty Of Medicine Baghdad
the incidence and the clinical significance of gray zone in the clinical phases of chronic hepatitis B infection
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Background: five clinical phases were described in patients with chronic (HBV) infection: HBeAg- positive HBV infection, HBeAg- positive chronic HB, HBeAg negative HBV infection, HBeAg-negative CHB and occult HBV infection. Aim: This study aimed to determine the incidence of the unclassified phase (gray zone) in chronic hepatitis B patients and its significant in the clinical practice. Patients and methods: The study was conducted retrospectively on 109 patients' who have HBsAg positive for more than 6 months. The data recorded include; HbeAg and anti-HBe Ab, ultrasound of the abdomen, HBV DNA load and alanine aminotransferase (ALT), accordingly; we classify the patients to known clinical phases. Patients who were unfit one of these phases

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Publication Date
Sun Mar 01 2015
Journal Name
Baghdad Science Journal
Spectrophotometric determination of Phenylephrine hydrochloride and Salbutamol sulphate drugs in pharmaceutical preparations using diazotized Metoclopramide hydrochloride
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A spectrophotometric method has been proposed for the determination of two drugs containing phenol group [phenylephrine hydrochloride (PHP) and salbutamol sulphate (SLB)] in pharmaceutical dosage forms. The method is based on the diazotization reaction of metoclopramide hydrochloride (MCP) and coupling of the diazotized reagent with drugs in alkaline medium to give intense orange colored product (?max at 470 nm for each of PHP and SLB). Variable parameters such as temperature, reaction time and concentration of the reactants have been analyzed and optimized. Under the proposed optimum condition, Beer’s law was obeyed in the concentration range of 1-32 and 1-14 ?g mL-1 for PHP and SLB, respectively. The limit of detection (LOD) and l

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Publication Date
Sun Mar 07 2010
Journal Name
Baghdad Science Journal
The use of ultra-violet visible spectroscopy to determination some antibiotics beta-lactam in some drugs
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This research aims to use chemical reaction to determine some of beta lactam antibiotics which include cephalexin and ceftriaxone in some pharmaceuticals by formation Prussian Blue complexes and using them for the UV-Vis., determination of drugs at wavelengths range (700- 720)nm by reaction them with FeCl3 in the presence of reagent K3[Fe(CN)6] in acid media . The optimal experimental conditions for the complex formation have been studied such as volume of HCl , K3[Fe(CN)6] , FeCl3 ,temperature and reaction time .Analytical figures of merits obtained on applying the developed procedure for cephalexin and ceftriaxone resp. are Linearity,(2-10),(1-7)?g.ml-1 LOD(0.0601,0.0330) ?g.ml-1. The de

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Publication Date
Wed Dec 29 2021
Journal Name
Journal Of The College Of Education For Women
The Impact of the Seven Principles of Good Practice as a Teaching Technique on EFL Student –Teachers' Performance: سوسن سعود عزيز
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The interest in pre-service teacher training has become influential in teaching English as a foreign language, and the purpose of this training course is to prepare qualified teachers to teach effectively through the application of this technique by undergraduate students. This research aims to find out the effect of using the seven principles of good practice as a teaching technique on the fourth stage student-teachers’ performance at the College of Education for Women/University of Baghdad, during the academic year 2017-2018. The sample includes (60) students selected according to the stratified sampling method. The observational checklist used by the department to assess the student teachers’ performance during the practicum perio

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Publication Date
Tue Jul 23 2024
Journal Name
Haya: The Saudi Journal Of Life Sciences
Levels of Interleukin - 40 and Lipid Profile in patients with Helicobacter pylori Infection
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The study was carried out to detection of H.pylori in (200) patients who attended two teaching hospitals in Baghdad. The diagnosis done by Immunochromatography methods. Stools and blood samples was taken from each patient as well as other (30) healthy control matching in their age. The study included detection the Levels of Interleukin-40 and CRP in sera of patients and control. The result indicated presence of H pylori antigen in 115 cases 59 cases of males and 51 of females, Also, the result indicated increasing levels of IL-40, cholesterol, Triglycerides, Low density lipoprotein, Very Low density lipoprotein increased significantly while the level of High density lipoprotein decreased in patients sera in comparison with healthy c

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Publication Date
Tue Jan 30 2024
Journal Name
Health Education And Health Promotion
Effectiveness of an Educational Program on Nannies' Practice Regarding Cholera Infection in the Nurseries
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