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Safety Profile of Biological Drugs in Clinical Practice: A Retrospective Pharmacovigilance Study

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
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

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

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 May 01 2019
Journal Name
Journal Of Engineering
Postmodern Architecture between the pillars of philosophical discourse and architectural practice

Postmodern arguments, formed a critic case of what modernity brought in several levels. Postmodern practice was considered as a proactive case having amorphous concepts and features to what entiled as an intellectual trends postmodern philosophically and intellectually. But, what postmodernism architecture broughts in it essence, was not isolation from the intellectual context and entrepreneurship case, and it was not disconnecting from the intellectual and philosophical era of that period. Lliteratures and philosophical argument precede what (Robert Venturi) and (Charles A Jencks) had brought, albeit it was closer to critics and correction the path of modernity from crystallizing a direction that exceeds modrinity to wh

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Publication Date
Tue Dec 01 2015
Journal Name
Journal Of Engineering
Valuation the Impact of Risks on the Goals and the Safety of Construction Projects in Iraq

Construction projects have a special nature and affect them many factors making them exposed to multiple risks as a result of the length of the implementation period and the multiplicity of stages, starting from the decision stage through implementation until the final delivery, which leads to increased uncertainty and the likelihood of risk.
The process of analysis and risk management is one of the effective and productive methods that are used in managing the construction projects for the purpose of increasing the chances of ending the project successfully in terms of cost, time and quality and at the lowest possible problems.

The research aims first to the effective planning for analysis and risk managemen

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Publication Date
Sun Oct 27 2019
Journal Name
Iraqi Journal Of Science
Correlation Between Chlamydia pneumoniae Infection and Lipid Profile in Patients with Cardiovascular Diseases

      Cardiovascular disease (CVD) is a class of diseases that involve the blood vessels or heart. Chlamydia pneumoniae has been considered as the most reasonable; also, it is able to increase and persevere inside vascular cells and to make the chronic inflammation in atherosclerosis. In this study, blood samples were subjected for molecular detection of Chlamydia pneumoniae by using conventional polymerase chain reaction (PCR) depending on 16S rRNA. Seventy patients who suffer from cardiovascular diseases (angina, myocardial infarction and atherosclerosis) aged between 33-86

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Publication Date
Sat Mar 30 2019
Journal Name
Journal Of Pure And Applied Microbiology
Antibiotic Resistance of Isolated Gram Negative Bacilli from Different Clinical Sample in a Central Teaching Hospital of Pediatric in Baghdad

The number of infections caused by microorganisms is increasing significantly over the last few years. A total of 140 patients admitted to the central teaching hospital of pediatrics from the 1st of Jun 2017 to 31 October 2017. The Clinical samples was processed from culture and sensitivity testing. Antibiotic discs used for gram negative isolates. The most prevalent gram negative isolates included Escherichia coli 63 (45.0 %), Pseudomonas spp. 21 (15.0 %), Klebsiella spp. 19 (13.6 %) predominantly. Escherichia coli were the most prevalent isolates from urine 45 (71.4 %), Klebsiella spp. 11 (57.9 %) and Enterobacter spp. 11 (68.8 %) followed by Escherichia coli 10 (15.9 %) predominant from blood. 68 (48.6 %) of specimens were urine, 47 (33.

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Publication Date
Sat Jul 01 2023
Journal Name
Analytical Science & Technology
Metal complexes of alizarin and their biological and industrial applications: A literature review

Alizarin is one of the popularly used and wide separated compounds with a chemical name (1,2- dihydroxy-9,10-anthraquinone) which belong to the anthraquinones family that contain three aromatic conjugated rings and in the central rings it contains two ketonic groups.1

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Publication Date
Mon Jul 04 2022
Journal Name
Al Mustansiriyah Journal Of Pharmaceutical Sciences
Bis-Schiff Bases of Isatin Derivatives Synthesis, and their Biological Activities: A Review

Isatin is a heterocyclic molecule that belongs to one of the most important classes of organic compounds known as indolines. Isatin, isatin analogs, and their Schiff bases have recently attracted a lot of attention in medicinal chemistry. Isatin, itself, shows various biological activities such as antiviral, anticancer, antimicrobial, anti-inflammatory, analgesic, antioxidant, and anticonvulsant. Bis- Schiff bases containing isatin moiety have been known to possess a wide spectrum of pharmacological activities. This review offers up-to-date information on the most active isatin bis-Schiff bases, which would include anticancer, antimicrobial, antiviral, anticonvulsant, anti-inflammatory, and analgesic activities. These observations c

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Publication Date
Wed Jan 01 2020
Journal Name
Plant Archives
Study of the environmental parameters on cephalexin degradation by anodic oxidation with biological indication

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Publication Date
Sat Dec 29 2018
Journal Name
Journal Of Global Pharma Technology
Synthesis, Characterization and Study Biological Activity of Some New Compounds Derived From Phthalic Anhydride

In this research , phthallic anhydride ring is opened with 4-methyl aniline and acetone as a solvent to results the compound [I] that reacted with dimethyl sulphate and anhydrous sodium carbonate formation to phathalate ester [II], while the acid hydrazide compound [III], was obtained from mixed the compound [II]with hydrazine hydrate, Synthesis four type of shiff bases[IV]a-d was synthesized from the reaction of acid hydrazide [III] with aromatic aldehyde or ketone , when reacted Shiff bases with phthalic anhydride or naphthalicanhydride,I get eight derivatives of oxazepine [V]a-d , [VI]a-d. The bacterial activity of the new compounds studied by four species of bacteria: Esherichia Coli, Enterobactecloacae (Gram negative) and staphylococcu

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