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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
Thu Dec 01 2022
Journal Name
Microbiology And Biotechnology Letters
Production and Identification of Secondary Metabolite Gliotoxin-Like Substance Using Clinical Isolates of <i>Candida</i> spp.
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Publication Date
Sun Jun 04 2017
Journal Name
Baghdad Science Journal
Detection of zpx gene of Cronobacter sakazakii isolated from Clinical samples for Iraqi children under Two Years
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The study included 200 samples were collected from children under two years included (50 samples from each of Cerebrospinal fluid, Blood, Stool and Urine) from, (Central Children Hospital and Children's Protections Educational Hospital) The Iraqi Ministry of Health, the Department of Health Baghdad .the period from the first of 2015 September to the first of December 2015, Were obtained isolates bacterial subjected to the cultural, microscopic and biochemical examination and diagnosed to the species by using vitek2 system .The results showed there were contamination in 6.5% of clinical samples. The diagnosed colonies which gave pink color on the MacConkey agar, golden yellow color on the Trypton Soy agar and green color on t

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Publication Date
Thu Jan 01 2009
Journal Name
Diala, Jour
Synthesis of Schiff bases of 2-thio-5-aryl-1,3,4- oxadiazole derivatives of possible biological activity
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In this study, new derivatives of Schiff bases of 2-thio-5-aryl- 1,3,4-oxadiazole have been synthesized. The structures of these derivatives were characterized from their melting points, infrared spectroscopy and elemental analysis. The Schiff bases derivatives were tested for inhibition of E-coli and were all found to be active.

Publication Date
Sun Mar 04 2012
Journal Name
Baghdad Science Journal
Effect of alcoholic extract of Adhatoda vasica leaves on some biological performance of Ceratitis capitata larvae
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Many biological tests were done to study the effect of the crude alcoholic leaves extracts on the biological characteristics at the larvae fruit fly Ceratitis capitata with different concentrations of the extracts exposed 1,2,3,5 and 7.5 % at constant laboratory conditions includes the temperature and the relative humidity (27±2C0&70±5 % respectively). The results of the experiments showed that the alcoholic extracts of the plant effected the growth and the development of the larvae and pupae according to the concentrations . The alcoholic extracts proved to have the highest mortality tend to 66.76 % in larva treated with alcoholic at concentration 7.5 % the

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Publication Date
Fri Nov 01 2013
Journal Name
International Journal Of Advanced Research
The effects of alkaloid extracted of Solanum nigrum leaves on the biological performance of Dialerodus citri
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Publication Date
Fri May 01 2009
Journal Name
Diyala Journal For Pure Science
Synthesis of Schiff bases of 2-thio-5-aryl-1,3,4- oxadiazole derivatives of possible biological activity
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In this study, new derivatives of Schiff bases of 2-thio-5-aryl1,3,4-oxadiazole have been synthesized. The structures of these derivatives were characterized from their melting points, infrared spectroscopy and elemental analysis. The Schiff bases derivatives were tested for inhibition of E-coli and were all found to be active.

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Publication Date
Sat Dec 01 2012
Journal Name
Journal Of Economics And Administrative Sciences
Comparison between the empirical bayes method with moments method to estimate the affiliation parameter in the clinical trials using simulation
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In this research the Empirical Bayes method is used to Estimate the affiliation parameter in the clinical trials and then we compare this with the Moment Estimates for this parameter using Monte Carlo stimulation , we assumed that the distribution of the observation is binomial distribution while the distribution with the unknown random parameters is beta distribution ,finally we conclude that the Empirical bayes method for the random affiliation parameter is efficient using Mean Squares Error (MSE) and for different Sample size .

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Publication Date
Sun Mar 13 2011
Journal Name
Baghdad Science Journal
Evaluation the efficiency of Trichomonas vaginalis depending on clinical sings , direct examination ,culturing and serological test
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The adequacy of diagnostic tests, together with trichomoniasis associated clinical symptoms, were investigated in females suffering vaginitis, and they were referred to the Gynecology Department, Al-Yarmouk Teaching Hospital during the period December 2004 – June 2005. The total number of patients was 250 cases (age range: 18 - 52 years), and each patient was examined using a sterile speculum to obtain vaginal swabs for examination. The diagnosis with T. vaginalis was done in many methods. The direct methods included wet and stained (Leishman's stain) examinations and cultivation in different culture media (Kupferberg Trichomonas Broth Base;, Trichomonas Agar Base; TAB and Trichomonas Modified CPLM), while the indirect methods were serol

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Publication Date
Sat Jul 08 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
The Effect of Coumarin Derivatives(compounds) on the Vibrio cholerae Isolates from Different Clinical Iraqi Sources
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From a large number of bacterial samples collected from different hospital in Iraq in central  health laboratory ,only ten isolates were identified primary as Vibrio. A number of  morphology and biochemical test were carried out to complete this identification that showed all bacterial isolates were related to Vibrio cholerae .In this study  all Vibrio isolates were investigated for Bio typing and the result showed that all (10) isolate were related to (Eltor biotypes) .Also, the susceptibility test towards eight antibiotics were carried  out .

Results shows that  ciprofloxacin , Norfloxacin, Erythromycin, Ampicillin,  ceftriaxone  and Amikacin were the most effective

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Publication Date
Thu Jan 01 2026
Journal Name
Iraqi Journal Of Science
Impact the Some Antibiotic on Gene Expression Efflux Pump of Klebsiella pneumoniae Isolated from Clinical Sources
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