6^th Pharmacovigilance Congress September 28-30, 2016 Toronto, Ontario, Canada

Biography:

Sutapa Bandyopadhyay Neogi is a Public Health Specialist actively engaged in Research and Teaching at Indian Institute of Public Health-Delhi, Public Health Foundation of India (PHFI) as an Additional Professor. An MBBS from Nil Ratan Sircar Medical College, Calcutta and MD in Community Medicine from Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, and Diplomat of National Board (DNB) in Maternal and Child Health, she has excellent academic credentials. She has a rich experience in public health, starting a career as a Resident followed by Consultancy for UNICEF and currently a Faculty at IIPHD. She is a part of the research team for projects supported by Government of India and developmental partners. She is a Reviewer of many national and international journals.

Abstract:

Gender preference is an integral part of society even today in India. The innate desire to have at least one son have forced people to resort to sex selection techniques - be it traditional or modern. Among various practices is a practice of intake of sex selection drugs (SSDs) reported to be taken by pregnant women during initial months of pregnancy to beget a male child. SSDs are indigenous preparations that contain certain herbal and non-herbal ingredients and are not sold over-the-counter. Stringent rituals are supposed to be followed for its success. A preliminary small community based study indicated that 46% of the women gave a history of intake of SSDs. Risk to the fetus might be involved as these are consumed at a time when sexual differentiation takes place at 6-10 weeks of pregnancy. Population based case control studies were conducted in Haryana, a state in India with skewed sex ratio. The study with structural birth defects as the outcome shows that the risk of birth defects with the intake of such medicines increase by 3 times. (Adjusted Odds Ratio 3; 95% CI 1.7, 5.6). The likelihood increases further in the absence of sons in the previous pregnancies (Adjusted OR 3.4; 95% CI 1.7, 6.9). Another study that aimed to look at the association with stillbirths showed that the risk increase by 2.5 times (Adjusted OR 2.6; 95% CI 1.5-4.5). The study concluded that for every 5 women who took SSDs one woman had stillbirth. Preliminary analyses of 30 SSDs indicate that these contain phytoestrogens and testosterone. 63% drugs contained phytoestrogens (genistein, daidzein, formononetin). The average dose of daidzein was 14.1 mg/g, genistein 8.6 mg/g and formononetin 5 mg/g of sample, which is above the normal acceptable dosage. The dosage along with the timing (first trimester of pregnancy when the fetus is growing actively) are crucial factors that may give rise to myriad of complications, both immediate and late. 

Biography:

Melanya A Samvelyan has completed her PhD from Supreme certifying commission of the RA and Post-doctoral studies from Yerevan State University. She is Associate Professor of Chair Organic Chemistry, and same time Senior Researcher of- Research Laboratory “Chemistry of N-,S-,O- containing heterocyclic compounds”. She has published more than 50 international thesis, patents and articles in the reputed journals.

Abstract:

Heterocyclic compounds are attractive objects for chemists and pharmacologists. Particularly derivatives of triazoles acted as active pharmaceutical agents and used as antitumor, anticonvulsant, antifungal, insecticidal, anticancer and antidepressant. It's known that the triazole's ring is enough stability and decomposes in harsh environments, and it is the main thing that the triazole ring containing drugs generally not confirmed destruction during of the time metabolism. For the enhancement of activity derivatives of 1,2,4-triazoles, we imported  bioactive fragments, such as morpholine, secondary amines, pyridine  and other fragments which  are already part of many medications. We was carried out number of methods for the synthesis of new derivatives 1,2,4-triazoles, studied  the reactions of Mannich, Michael's and reactions of substitution  mercapto  groups for our systems. Below there is a graphical scheme of our research. We have also shown that the mercapto triazoles are antioxidants and anti-radiation good agents. So in this work we synthesized bis-heterocyclic compounds, where the triazole ring is aligned with the mercapto triazoles and mercapto oxadiazoles. We are sure that the synthesized compounds are bioactive.

Biography:

Pierrot Mwamba T is Associate Researcher in Drug Analysis and Industrial Pharmacy. He has completed his Post-graduation in University of Lubumbashi. He has published one paper in The Pan African Medical Journal. Currently, he is being trained by Professor Jean Baptiste Kalonji and Professor Pierre Duez on research theme: Counterfeiting drugs in D R Congo.

Abstract:

Counterfeit medicines represent a major health risk in the treatment of various pathologies. They are responsible for resistance emergence in the treatment of infectious diseases. This study was conducted in order to identify illegal and legal drugs marketed in the city of Lubumbashi and assess the quality of all samples concerned by this study. The study included amoxicillin and amoxicillin + clavulanic acid for oral administration. Visual inspection of medicines, investigation of authenticity of drugs from pharmaceutical regulatory authorities, and determination of content were used as study parameters. A total of 48 samples were collected including 34 of amoxicillin and 14 of combination amoxicillin + clavulanic acid. 16 (33%) samples are not permitted to be marketed. 23 (33%) samples were substandard according to the US Pharmacopeia in terms of dosage of active ingredient. Out of 23, in 21 (91%) samples, the active ingredient was in lower amount (under-dosing) and 2 samples (9%) had both under-dosing and overdosing. The proportion of non-compliance is highest among medicines non permitted to be marketed (81.25% vs 31.25%; p˂0,005). It is obvious that strengthening the capacity of the drug regulatory authority of the DRC reduces the influx of counterfeit drug and substandard

Biography:

Lavesh Patel is PhD student at South College School of Pharmacy, USA

Abstract:

This study was conducted to identify over-the-counter (OTC) medications and supplements that have been removed from the market due to the inclusion of undeclared prescription ingredients. Information was obtained from the FDA database of MedWatch Safety Alerts for Human Medical Products from January of 2001 through December of 2015. A list of products as well as the undeclared ingredients was included in these products. Selected manufactures or distributers of the products were contacted for sale availability. A total of 594 OTC products were found to have undeclared prescription ingredients. The majority of these supplements were sold for weight loss (41%), sexual enhancement (40%) and muscle building (16%). There were other various supplements marketed for general health, arthritis, hyperlipidemia, prostate health, diabetes, feminine health, hypertension and sleep. The most common undeclared ingredient in the weight loss supplements was sibutramine, while sildenafil analogs were the most common in sexual enhancement supplements. Steroids were the most common undeclared ingredient in the muscle building products. Several products were found to be available for purchase in some capacity on the internet by secondary distributers. FDA and regulatory actions may be necessary to avoid manufacturers as well as secondary distributors of these agents. Proper knowledge of patient use of OTC product and its ingredients should aid in prevention of adverse drug reactions and interactions. 

Biography:

Maame Twum is a PHD student at South College School of Pharmacy, USA

Abstract:

This study was conducted to identify over-the-counter (OTC) medications and supplements that have been removed from the market due to the inclusion of undeclared prescription ingredients. Information was obtained from the FDA database of MedWatch Safety Alerts for Human Medical Products from January of 2001 through December of 2015. A list of products as well as the undeclared ingredients was included in these products. Selected manufactures or distributers of the products were contacted for sale availability. A total of 594 OTC products were found to have undeclared prescription ingredients. The majority of these supplements were sold for weight loss (41%), sexual enhancement (40%) and muscle building (16%). There were other various supplements marketed for general health, arthritis, hyperlipidemia, prostate health, diabetes, feminine health, hypertension and sleep. The most common undeclared ingredient in the weight loss supplements was sibutramine, while sildenafil analogs were the most common in sexual enhancement supplements. Steroids were the most common undeclared ingredient in the muscle building products. Several products were found to be available for purchase in some capacity on the internet by secondary distributers. FDA and regulatory actions may be necessary to avoid manufacturers as well as secondary distributors of these agents. Proper knowledge of patient use of OTC product and its ingredients should aid in prevention of adverse drug reactions and interactions. 

Biography:

Dong Yoon Kang has completed his PhD from Seoul National University and worked for Drug Safety Monitoring Center of Seoul National University Hospital. He had a Major in Preventive Medicine and Epidemiology of Adverse Drug Reaction.

Abstract:

Antibiotic skin test can be used for evaluating sensitization in patients with a history of antibiotics allergy. In many Asian countries including Korea, a routine unconditional pretest before using beta-lactam antibiotics is widely performed, but its clinical value for predicting allergic reaction in patients without prior reaction is not established. The aim of this study is to assess the actual conditions of cephalosporin skin test performed in a current clinical practice. From 2004 to 2015, nursing statements on antibiotics skin test and history of allergy or adverse drug reaction were collected from nursing records of adult inpatients. A total 86,822 cases of cephalosporin skin tests with 15 kinds of cephalosporins (cefazolin, ceftriaxone, flumoxef, cefotaxime, cefotetan, cefoxitin, ceftizoxime, cefodizime, cefepime, ceftazidime, cefpiramide, cefuroxime, cefmetazole, cephalothin, and cefotiam) were included in the study. Among the total of 86,832 cases; 1,139 cases (1.3%) showed positive results on intradermal skin tests. Cefotiam showed highest positive rate (42.7%) and cefuroxime was the lowest positive rate (0.55%). Comparing the result of cephalosporin skin test by a history of allergic disease or adverse reaction to any drugs, patients with the previous history of allergy or adverse drug reaction had higher positive rate than patients without (1.83% vs. 1.27, p<0.001). Interestingly, this correlation was reproduced only in cefazolin (3.26% vs. 1.43%, p=0.023) and cefotetan (3.91% vs. 1.01%, p=0.006) especially in association with any allergy history. However, validation in another institute shows different correlation of each cephalosporins. In conclusion, cephalosporin skin test positivity has weak association with allergy history of patients and varied according to individual cephalosporin. Doing skin test only in patients with allergy history is not clinically applicable.

Biography:

Armen S Galstyan has completed his PhD from Supreme Certifying Commission of the Republic of Armenia and Postdoctoral studies from Yerevan State University. He is Head of Educational Laboratory, Department of Organic Chemistry, YSU, and Research Associate of Research Laboratory, “Chemistry of N-, S-, O-containing Heterocyclic Compounds”. He has published more than 45 international thesis, patents and articles in the reputed journals.

Abstract:

One of the most interesting classes of organic compounds such as nitrogen, oxygen, and sulfur-containing heterocycles have a wide range of practical use. In particular 1,2,4-triazol-ring included in the structures of different biologically active molecules, are used as drugs with broad spectrum action, e.g. antimicrobial (Fluconazole, Itraconazole), anticancer (Vorozole, Letrozole, Anastrozole), and some derivatives have antibacterial, antifungal, antitumour, anti-inflammatory, antitubercular, hypoglycemic, antidepressant, anticonvulsant, antiviral and analgesic activity. This work presents some synthetic possibilities of 3,4-disubstituted-5-mercapto-1,2,4-triazoles to obtain new potentially biologically active compounds. For functionalization of tria­zoles, we carried out the cyanoethylation and (methoxy­car­bonyl)ethylation reactions in the reaction conditions. The basic and acid hydrolysis of the resulted compounds was realized, which led to the corresponding 3-heterylsubstituted propionic acids. Hydrazinolysis of synthesized esters of hydrazides were obtained. The last are given in 1,3,4-oxadiazoles and pyrazoles according to known methods. Sulfur-substituted 1,2,4-triazoles derivatives may also be interesting in biological viewpoint. This would enable the biological activities of free and substituted thiols to be compared. Therefore, 1,2,4-triazoles were alkylated by various aralkyl halides. In order to obtain the derivatives of thiazolo[2,3-c]-1,2,4-triazoles studied the bromination reaction of 4-allyl and 4-methallyl substituted triazoles. Preliminarily tests of compounds S-derivatives for antioxidant activity revealed that the latter exerts stabilizing effect on red blood cell membranes. Screening of some compounds revealed that they exhibit feebly marked antibacterial and anti-yeast activity. But 3-benzyl-1-(2-(5-mercapto-1,3,4-oxadiazol-2-yl)ethyl)-4-phenyl-1H-1,2,4-triazole-5(4H)-thione could inhibit the growth of Gram positive bacteria.

Biography:

Tariel V Ghochikyan has completed his Doctor of Sciences degree from Supreme Certifying Commission of the Republic of Armenia (Yerevan State University). He is Dean of the Department of Pharmacology and Chemistry, YSU. He is Supervisor and Master Researcher of Research Laboratory, “Chemistry of N-,S-,O- containing heterocyclic compounds”. He has published more than 225 articles, international thesis and patents in the reputed journals. He is the member of the Council of YSU, member of special soviet unions. He is an Editorial Board Member of Chemical Journal of Armenia, and also for the proceedings of YSU Chemical and Biological Sciences.

Abstract:

A wide range of biological action and prevalence of lactone-containing compounds in the nature become attractive objects for research by both specialists in fine organic synthesis and pharmacologists. There are numerous drugs used in medicine that contain active aglycones derivatives of γ-lactones. The relevance of research in the field of γ-lactones is confirmed by numerous recent publications. In continuation of our research in this field, we have developed a number of methods for the synthesis of new, earlier not described in literature lactone-containing compounds that can be of certain practical interest. Below there is a graphical scheme of our research. Screening of compounds 1,2 revealed that they displayed inhibitory activity in relation to major phosphatases. It is shown that the inhibitory activity of the main part of studied compounds exceeded similar properties of the known inhibitors levamisil and L-phenylalanine by 17-80 times. Compounds 3 are of certain interest. Their studies have shown that representatives of this class have mainly antibacterial properties were used Gram-positive staphylococci (209P, 93) and gram-negative rods (Sh. Flexner 6858, E coli 0-55), all compounds had moderate anti­bacterial activity. Screening has revealed antimutagenic properties in a series of γ-lactones for the first time (compounds 3, 4). The experiments were carried out on Salmonella tiphimurium TA-100. It was established that with these compounds the number of revertants decreased by 55-60% and mutagenicity factor w        as 2.58-2.7. The same compounds exhibited algicidal activity against filamentous green algae Cladophora. The mentioned compounds in 1 mg/ml concentration destroy cells for 51-60% against 14% of the control preparation monuron. Undoubtedly, compounds 3, 4 can be used in solution of some ecological problems.
 

Biography:

Mohammed Farhad Ibrahim is a third year PhD student in Natural Product Chemistry and Drug Discovery from medicinal plants. He was awarded MSc degree at University of Pavia, Italy. He worked as Supervisor in the department of Cosmetic and Pharmaceutical Products at Xenofarma company.

Abstract:

Introduction: People living on the mountains of the Kurdistan region in Northern Iraq use large amount of herbs for local traditional medicine. Among them, T. systola, which grows under and between rocks, is very popular as a herbal anti-inflammatory remedy and pain-relief; two or three fresh bulbs eaten by the patient particularly during inflammation and birth pain. Tulipa systola Stapf. was collected in April 2014 on the Korek Mountains in Rewanduz-Erbil/Kurdistan region. The materials were identified and classified from Education Salahaddin University Herbarium (ESUH) by Dr. Abdullah Sh. Sardar, at the University of Salahaddin, Erbil-Iraq. A voucher specimen was deposited with the accession number (7201).

Experimental: Tulipa systola roots, leaves and flowers (100 g each) were separately defatted with petroleum ether (500 mL), in an ultra-sonic bath for 30 min, then macerated for 3h under continuous stirring at room temperature. The procedure was repeated three times for each part. Defatted roots, leaves and flowers were subsequently separately extracted with ethanol (500 mL) in an ultra-sonic bath for 30 min, and then macerated for 3h under continuous stirring at room temperature. The procedure was repeated three times for each part. The mixtures were then filtered and the solvent was removed under “vacuum” in a rotary evaporator to afford crude ethanol extracts: TR from roots, TL from leaves and TF from flowers, respectively. The concentrated extract TR, TL and TL (1 g), each extract separately was chromatographed over (MPLC (Isolera) RC18, Methanol/Water; (20:80 – 100% methanol) gradient to afford different fractions. From further purification of these fractions, some pure bioactive compounds isolated and then identified by spectroscopic; IR, UV, NMR and MS analysis as, TRD2: (+) 1-O-feruloyl-3-O-p-coumaroyl-glycerol and TRB2: (+) 6-tuliposide A from Roots, TLW5 and F3: (-) Kaempferol-3-O-rutinoside from both Leaves and Flowers part.

Results: This is the first report about phytochemical constituent of Tulipa sytola Stapf. growing in Kurdistan region Iraq. The radical scavenging and antioxidant activity of the isolated compounds were evaluated on four tests: DPPH free radical scavenging activity, ferrous ion-chelating power test, total antioxidant activity, hydrogen peroxide scavenging activity, which were carried out as described in the literatures. Compared to the reference ascorbic acid the IC50 values of the most active compounds were: (DPPH; IC50, Ascorbic acid 55 µg/ml > F3 65.4 µg/ml > TRD2 77.1 µg/ml > TRB2 135.5 µg/ml), (hydrogen peroxide scavenging; IC50, F3 36.91 µg/ml > Ascorbic acid 38.37 µg/ml > TRD2 40.83 µg/ml), (TAOC; IC50, Ascorbic acid 57.53 µg/ml > TRD2 81.99 µg/ml > F3 121.08 µg/ml). The significant antioxidant and antiradical activities determined for the different compounds give scientific support to the traditional use of the plant by the Kurdish people as a popular anti-inflammatory remedy and pain-relief and a great subtend to become a starting point for in vivo investigation in the next steps.

Conclusions: To the best of our knowledge, the optical active isomer of compound TRD2 (+) 1-O-feruloyl-3-O-pcoumaroyl-glycerol for the first time had been isolated from Tulipa systola roots. The study of the variety of secondary metabolites occurring in T. systola as a potential source for natural bioactive chemicals, as well as their precise antioxidant mechanisms, is therefore worthy of being carried out, and it will be reported in due time.

Biography:

Cécile Leger works at Normady University, « NeoVasc » Laboratory, Inserm, IRIB, Rouen University, France.

Abstract:

During brain development, the NMDA receptor exerts trophic activities and is required for a correct integration of GABAergic interneurons. The literature informs us that a prenatal alcohol exposure impacts the glutamatergic transmission. It is now established that brain vessels are involved in the migration of GABAergic neurons and we recently showed that endothelial cells express NMDA receptors. In the present study, we hypothesized that in utero alcohol exposure might impact the cortical integration of GABAergic neurons via an alteration of the endothelial cell activity. Using Gad67-GFP mice, we investigated the effects of a prenatal alcohol exposure on the survival of GABAergic precursors, the activation of endothelial MMPs and tPA and the long term integration of GABAergic neurons in the neocortex. Treatment of cortical slices from E15 fetuses with ethanol revealed no significant modification of the apoptotic death. In contrast, both in situ and gel zymographies showed that alcohol markedly reduced the proteolytic activities of MMP9 and tPA in cortical microvessels. These effects were mimicked by the NMDA antagonist MK801. A long term follow-up of the GABAergic interneuron population revealed that a prenatal alcohol exposure increased the density of cortical GABAergic neurons and GFP expression levels but decreased the density of primary dendrites per neuron. Altogether, these findings support that a prenatal alcohol exposition disturbs the activity of vascular matrix proteases and the long term integration of GAD67-GFP interneurons. They raised the question of long term effects of molecules with NMDA antagonist properties such as anesthetics.

Biography:

Kyoung Hee Sohn received a Bachelor’s degree from Kyungpook University School of Medicine. She is currently pursuing her Specialization in Clinical Pharmacolocy and Therapeutics at the Seoul National University Hospital. She has published some papers in SCI journals in the field of allergy and pharmacovigillance and is speaker in several global conferences.

Abstract:

Background: Oxaliplatin-related hypersensitivity reactions (HSR) are well-known, raising a dilemma for use of critical drug in cancer patients for fear of inducing severe reactions and even fatal, anaphylactic reactions. However, the prevalence varies and data on the incubation period for sensitization and grade of severity have not been reported prospectively.

Methods: We performed prospective, observational study with 745 patients treated with oxaliplatin-based chemotherapy between March 2003 and January 2015 in Seoul National University Cancer Institute. Oxaliplatin HSR was assessed by structured telephone interview. We examined prior exposure to oxaliplatin, incubation period, severity of HSR and premedication treatments.
 

Results: During the period, a total of 745 patients were enrolled, and 148 (18.7%) HSR events were reported. Depending on patients with prior exposure to oxaliplatin, 40.3% of previous exposed group exhibited HSR (48/119), significant higher than non-exposed group. (15.9%, (100/526), p < 0.0001, by Fisher's exact test). The average median cycle of the HSR was 3.31 in previous exposed group. In contrast, previous non-exposed group experienced HSR at cycle 4.53 (p<0.0001). By National Cancer Institute criteria (version 3.0), the severity of HSR was higher in patients with a previous history of oxaliplatin than in patients without previous exposure. (Grade 2.8±0.1 (Gr 1: 8.3%, Gr 2: 25.0%, Gr 3: 47.9% and Gr 4: 18.8%) vs. Grade 2.3±0.1 (Gr 1: 14%, Gr 2: 42%, Gr 3: 41% and Gr 4: 2%), respectively (p=0.005).

Conclusions: In this prospective study, we observed that patients with any prior exposure to oxaliplatin experienced earlier onset and more severe HSR with a higher frequency, despite of premedication. We concluded that patients with history of exposure to oxaliplatin HSR in early cycle with severe allergic reactions can occur and is needed for tailored modification such as desensitization.

Biography:

Faten Sabbagh is a PharmD Candidate at South College School of Pharmacy in Knoxville, Tennessee, USA. Her undergraduate study included Biological Sciences at the University of Michigan-Dearborn and Henry Ford College. He has been in the practice of pharmacy since 2010 with certifications in Medication Therapy Management, AHS-BLS, Immunization Delivery, Smoking Cessation, and Diabetes. Her areas of interest are Pharmacokinetics, Pharmacovigilance and Patient Safety.

Abstract:

This study was conducted to evaluate published and manufacturer labeling information (PI) for commonly prescribed drugs in the USA, and to examine compliance with the new 2015 FDA labeling guidelines. Data were also compared to the authors’ previously published information on the development of the first clinical classification of drugs used during lactation (FG-LA). Of the top 200 drugs prescribed in 2015, 85% included a lactation section but information was limited and not in compliance with all elements of FDA guidelines. Only 5% included risk versus benefits section, 54.5% were excreted into breast milk or included data on milk-plasma ratio. Utilizing FG-LA clinical classification, 53.5% were clinically compatible with lactation but 19.5% caused mild to moderate adverse effects on infants, and 1.5% caused mild to moderate adverse effects on the mothers. A total of 23.5% were classified as incompatible with lactation, secretion of 11.5% was unknown, 6.5% caused mild to moderate adverse effects on infants and 1.5% caused mild to moderate adverse effects on the mothers. A total of 23% were classified as unknown with compatibility and no data on adverse effects were reported on infants or mothers. A total of 25.5% caused adverse effects on infants and 3% had adverse effects on the lactating mothers. Several conflicts existed between data in the PI and the literature addressing secretion or concentrations in breast milk. A firmer deadline is recommended by the FDA to drug manufacturers to update PI data in order to enhance patient safety and therapeutic outcomes.

Biography:

Majdi Garsan Algarsan is a student in Department of Pharmacy at University of Hertfordshire, UK.

Abstract:

Numeracy skills are needed by both adults and children in their daily activities. Improving numeracy skills in whatever possible method is important for better performance in every work of life. Doctors, Nurses and Pharmacists need to be very skillful in numeracy in determining doses or administering medicines. Pharmacy students during training must improve their numeracy. Numeracy skills are important for the daily practice of pharmacists to be able to determine doses of drugs. There were incidents where due to error in calculation during the formulation of a medicine that cause the death of some pediatric patients. The peppermint incident is an example of the important requirement of numeracy skills. Medication errors cost the NHS about 750 million pounds annually and dosage errors from calculations are part of them which are mainly due to errors in calculations. The aim of the study was to find out the numeracy skills of MPharm year 1 and year 2 students at University of Hertfordshire and to find out effect of MyMathLab in improving numeracy skills of this group of students. MPharm student in year 1 and 2 were selected from the University of Hertfordshire. Research was done in two segments. Exams and questionnaire send to students by email. Students were given three sets of exam: Induction, Formative and Summative. Exams were marked and analyzed statistically using One-way ANOVA. The questionnaire was made using a programme called ‘Survey Monkey’. The questionnaire explored their demographics and what they thought of the numeracy support on their course. Statistical analysis such as the CHI-Square test was applied to the results from the online questionnaire to find out if the results were significant. Themed analysis was completed on the transcribed data for student`s feedback from the Questionnaire. 

Biography:

In the year 1985. Branka Janicijevic has completed her Ph.D. in Biology ,Faculty of Natural Sciences and Mathematics, University of Zagreb, Croatia. She is a Research Professor of Anthropology at the Institute for Anthropological Research in Zagreb and Professor of Anthropology, Faculty of Humanities and Social Sciences, University of Zagreb, Croatia. Her research interests are interdisciplinary biocultural research of isolated populations, population genetics and molecular anthropology. According to Web of Knowledge database she had 89 scientific papers, 1813 citations and h-index is 20.

Abstract:

The ADME genes exhibit significant variation among the human populations due to the past demographic and evolutionary events. Genetic distinctiveness is especially pronounced in isolated populations where the exchange of genes with other populations is minimal and where the increased frequency of otherwise rare or private alleles emerges. The example of such population are the Roma, the transnational minority population of Indian origin with centuries long sociocultural isolation which left traces in their gene pool showing considerable differences in comparison to other populations. Therefore, we investigated the variation of a large panel of ADME genes among several Roma minority populations residing in Croatia. Here we present the results of CYP2B6 gene variation which was detected by genotyping five SNP loci (rs12721655, rs2279343, rs28399499, rs34097093, rs3745274, rs7260329, rs8192709) in the three socioculturally and geographically distinct Roma populations living in northern, central and eastern regions of Croatia. Two of the investigated loci (rs28399499, rs34097093) were monomorphic in all samples, while locus rs12721655 was polymorphic only in Roma population from the northern Croatian region of Medjimurje. Its MAF was 21.5% that is considerably high since the global MAF is <1%. MAFs of other loci (rs2279343, rs3745274, rs7260329, rs8192709) ranged from 17-30%, 12-26%, 24-45%, 5-17%, respectively, which is mostly in concordance with their global distributions. The exact test of population differentiation based on genotype frequencies showed marked differences between populations. Significant LD values between pairs of loci were detected in all tree investigated populations. The results indicate the Roma population’s distinctiveness and provide a theoretical basis for safer drug administration that may be relevant for treating diseases in this population.

Biography:

Dr. Min-Gyu Kang is working at Chungbuk National University College of Medicine, Cheongju, Korea

Abstract:

Background: Adverse drug events (ADE) has been recognized as an important cause of serious morbidity and mortality. Severe cases of ADE requires immediate medical treatment including Emergency Department (ED) visits. However, the epidemiologic features of ADE leading to ED visits have not been well described in Korea. We aimed to estimate the prevalence and features of ADE leading to ED visits.

Methods: In this retrospective observational study, we reviewed all the cases of ED visits for six months, from July 2014 to December 2014, in two university hospitals in Seoul and a university hospital in Cheongju in South Korea. By reviewing all the medical records including National Emergency Department Information System Database, we identified cases of ADE and assessed the causative drugs, severity, types and preventability.

Results: The most common causative drugs of ADE was antineoplastic drugs, insulin and antidiabetic drugs, antithrombic or antiplatelet agents and vaccines. In terms of system of clinical manifestations, gastrointestinal, skin, body as a whole, neurologic and metabolic/nutritional symptoms were most frequent. The most common diagnoses of ADE were complication of insulin (and antidiabetic drugs), complication of antithrombic (or antiplatelet) agents, dizziness, generalized skin rash, gastritis, and neutropenia

Conclusion: The prevalence of ADE in ED visits was common Korea and higher in older adults and females. Many cases of ADEs were preventable and predictable. Further prospective study is needed to evaluate the nationwide burden of ADE leading to ED visits.

Biography:

Dr. Nailesh Patel is working at S.K. Patel College of Pharmaceutical Education and Research, Ganpat University, Mehsana, Gujarat, India.

Abstract:

Objective: The main objective of the study is to determine the clinical endpoints bioequivalence between Test and Reference Albuterol inhalation formulation & to find out the superiority of test over placebo.

Methods: The study was conducted in asthma patients of either gender with methacholine challenge. Patients with known surgical histories, known and suspected cases of allergies and pregnant woman’s were excluded from this study. Total 260 patients were included. The design of the study was single-dose, double-blind, double dummy, randomized, crossover study with washout of at least 24 hours.

Result: Post-dose PC20 or PD20, which are the provocative concentration or dose, respectively, of the methacholine challenge agent required to reduce the forced expiratory volume in one second (FEV1) by 20% following administration of differing doses of albuterol (or placebo) by inhalation is 15.84±0.02. The 20% reduction in FEV1 is determined relative to the saline FEV1 measured before the placebo or albuterol administration. A significant dose-effect relationship was present (p < 0.0001). Deviation from parallelism of the test and reference dose-response curves (p = 0.95) and differences in overall mean response between the two formulations (p = 0.68) were not significant. The calculated 90% CI was 78.86-144.87% for FEV1. There were no serious adverse events observed during the study.

Conclusion: The 90% CI for the relative bioavailability (F) falls within the defined bioequivalence limit, i.e., 67.00-150.00%. Hence, it is concluded that Albuterol test formulation is bioequivalent to reference Albuterol formulation.