Scientific Program

Sessions:

International Conference on Pharmacognosy Pharmacovigilance

Abstract

Antimicrobial Agent Induced Hypokalemia: A Possible Causality Association. Harmeet Singh Rehana, Priyanka Hotha1 a Director Professor, Department of Pharmacology, Lady Hardinge Medical College, New Delhi, India 1 Senior Resident, Department of Pharmacology, Lady Hardinge Medical College, New Delhi, India. Abstract Background Drug induced hypokalemia may cause cardiac, muscular, renal, gastro intestinal and metabolic manifestations. Objective To study the association of antimicrobial agents (AMAs) with the development of hypokalemia as an adverse drug reaction (ADR). Methodology Retrospectively spontaneously collected individual case safety reports (ICSRs) with drug induced hypokalemia were analyzed. These ICSRs were further analyzed for age, gender, diagnosis, seriousness, severity, outcome, concomitant drugs, drug-drug interactions, management and causality assessment. Result Of the total of 2880 spontaneous collected ICSR, 53 had report title of hypokalemia. In almost half of these (27) ICSRs AMAs were suspected to induced hypokalemia. Ceftriaxone (24.5%), azithromycin (10.5%) and metronidazole were most suspected AMAs. Females (74.19%) aged between 21-40 years experienced more AMA induced hypokalemia. The mild, moderate and severe hypokalemia was present in 53.8%, 40.7% and 7.4% of ICSRs respectively. In six ICSRs there were Drug-drug interactions of AMA with either furosemide, hydrocortisone and or deriphyllin, known to cause hypokalemia. Causal association of AMA with hypokalemia was possible in all the cases. Conclusion Caution is recommended to monitor serum potassium levels of patients during the ceftriaxone, azithromycin, metronidazole administrtaion. Also to avoid drug-drug interaction of these AMAs with drugs known to cause hypokalemia.

Biography

Prof. Harmeet Singh, obtained his MBBS and MD (Pharmacology) from University of Delhi He was trained expert in Pharmacovigilance, Pharmaco-economics and Pharmaco- epidemiology. Virtue of which he is member of several national and international scientific bodies including WHO, ICMR etc. and national program viz Pharmacovigilance Program of India, and Revised National TB program.He is Member of several national and international scientific bodies He is also on the review boards of various national and international journals He has more than 65 publications in various journals including Tropical Doctor, Europian J of Pharamcology, Ethnopharmacology

Speaker
Harmeet Singh Rehana / Lady Hardinge Medical College, New Delhi, India.

Abstract

Effect of onion (Allium cepa) extract (OE) was investigated against acetaminophen (APAP) induced cytotoxicity and oxidative stress in isolated rat hepatocytes. Isolated hepatocytes were prepared with the collagenase perfusion method. In this technique, liver is perfused with collagenase after the removal of calcium ions (Ca2+) with a chelator (EGTA 0.5 mM). Isolated hepatocytes (10 mL, 106 cells/mL) were incubated in the Krebs Henseleit buffer (pH 7.4) in continuously rotating 50 mL round bottom flasks, under an atmosphere of carbogen gas (95% O2 and 5% CO2) in a 37 °C water bath. Cytotoxicity, ROS formation, and mitochondrial membrane potential collapse were assessed as oxidative stress markers and the role of Allium cepa extract on them was evaluated. APAP administration (500 µM) to rat hepatocytes was accompanied with cytotoxicity, ROS formation, glutathione reservoirs (GSH) depletionand mitochondrial depolarization. OE (100µl) significantly reduced cell death, ROS formation and its consequences such as decrease in cellular GSH and mitochondrial injury induced by APAP. These results indicate that the crude extract of Allium cepaexhibits hepatoprotective action probably through antioxidativeproperties and protecting cellular vital organelles such as mitochondria.

Biography

1990-1996: Instructor in pharmacologyTeaching Assistant. September 2002- April 2003. Faculty of Pharmacy, University of Toronto, Toronto, Canada. Pharmaceutics Laboratory. PHM 224Y.September 1997- April 2002. Faculty of Pharmacy, University of Toronto, Toronto, Canada. Medicinal Chemistry PHM 222Y Channels, pumps and transporters section.January –April 1999. Faculty of Pharmacy, University of Toronto, Toronto, Canada. Metabolic Biochemistry PHM 226S. Neurons and Glial Cells section. 2004-present: Associate professor of pharmacology

Speaker
Mohammad Ali.Eghbal / University of Toronto, CANADA

Abstract

During the last decade Sweden has invested in a national infrastructure for collection of structured clinical data in the form of healthcare registries (in Sweden known as Kvalitetsregister). This data can be combined with other public data using the national personal identifiers that is issued to Swedish citizens. The healthcare registries have an almost complete coverage of Swedish healthcare and a large network of clinicians is involved in the quality assurance and continuous improvement of healthcare using these registries. Uppsala Clinical Research Center (UCR) has been a technology provider of large scale national registries and has a strong background in clinical trial management. This effort combines the areas of healthcare registries and clinical trials into a novel way of performing clinical trials to be able to 1) run clinical trials as an integrated part of normal clinic workflow and 2) leverage the nationwide network of outcome reporting. This strategy was proven a tremendous success in the TASTE (Thrombus Aspiration in Myocardial Infarction) study. After TASTE was published the New England Journal of Medicine wrote a perspective on the study calling it “The randomized registry trial – the next disruptive technology in clinical research?” The registry-based RCT is an efficient and effective mechanism to assess hard clinical endpoints in large patient cohorts. Hitherto, registry based randomized trials have evaluated treatments strategies and devices or simples pharmaceutical agents, but there is no strict limit to what therapy can be evaluated with the registry link as long as patient safety is assured and there is adherence to existing regulations. Registry-based RCTs with more efficient and streamlined trial conduct may also be possible for evaluation of approved pharmaceutical agents for new indications and labels. The benefit of the RRCT is related to the ability to identify patients, enroll larger proportions of patients in relative short time and a possibility of indefinite follow-up. Together with the fact that a RRCT often is much more inexpensive than an ordinary RCT has made the RRCT renown on a global scale. Since then several studies has been conducted this way with great success. UCR has been appointed, by Clinical Studies Sweden and the Swedish Research Council, to develop the Swedish national guidelines for registry-based randomized clinical trials in order to ensure the possibility for more organization to run this kind of studies. The guidelines consists of documentation on the specifics on running a clinical trial as an RRCT as well as a technical framework. The framework specifies the domain of Clinical Trials and defines business rules for legal compliance. The building blocks of the framework are combined to support the clinical trial at hand and coupled to the registry after being validated against the study protocol. The clinical trial implementation is treated as a stand-alone application which shares life-cycle with the registry. This architecture handles the incompatible legal requirements between clinical trials and registries with regard to patient/participant opt-out. The presentation will cover the basic of registry-based randomized clinical trials, examples of studies conducted so far and the guidelines which is available for everyone who wants to conduct a clinical trial this way.

Biography

Experienced Manager with a demonstrated history of working with IT in Healthcare. Strong professional skilled in Scrum, Distributed Team Management, Web Applications, Enterprise Software, and Agile Methodologies.

Speaker
Peter Hedman / Uppsala Clinical Research Center, Sweden

Abstract

Abstract: The strategy of price liberalisation and privatisation had been implemented in Sudan over the last decade, and has had a positive result on government deficit. The investment law approved recently has good statements and rules on the above strategy in particular to pharmacy regulations. Under the pressure of the new privatisation policy, the government introduced radical changes in the pharmacy regulations. To improve the effectiveness of the public pharmacy, resources should be switched towards areas of need, reducing inequalities and promoting better health conditions. Medicines are financed either through cost sharing or full private. The role of the private services is significant. A review of reform of financing medicines in Sudan is given in this article. Also, it highlights the current drug supply system in the public sector, which is currently responsibility of the Central Medical Supplies Public Corporation (CMS). In Sudan, the researchers did not identify any rigorous evaluations or quantitative studies about the impact of drug regulations on the quality of medicines and how to protect public health against counterfeit or low quality medicines, although it is practically possible. However, the regulations must be continually evaluated to ensure the public health is protected against by marketing high quality medicines rather than commercial interests, and the drug companies are held accountable for their conducts. Keywords: Sudan, Healthcare, Medicines, Regulatory authorities, Pharmacy Management. 1. Introduction The World Health Organisation [1] has defined drug regulation as a process, which encompasses various activities, aimed at promoting and protecting public health by ensuring the safety, efficiency and quality of drugs, and appropriateness accuracy of information (WHO, 2009). Medicines regulation is a key instrument employed by many governments to modify the behaviour of drug systems. The regulation of pharmaceuticals relates to control of manufacturing standards, the quality, the efficacy and safety of drugs, labelling and information requirements, distribution procedures and consumer prices (Sibanda, 2004). To assure quality of medicines, in most countries registration is required prior to the introduction of a drug preparation into the market. The manufacturing, registration and sale of drugs have been the subject of restricts regulations and administrative procedures worldwide for decades (Lofgren, and Boer, 2004). Nobody would seriously argue drugs should be proven to be 100% safe. No set of regulations could achieve that goal, because it is impossibility and all drugs carry some risk (Lexchin, 1990). Stringent drug regulation was introduced across many countries in the 1960s following the thalidomide disaster, and had since been embraced by the industry as a commercial essential seal of safety and quality (Lofgren, and Boer, 2004). In spite of the measures, many countries, especially developing ones face a broader range of problems. In several developing countries drug quality is a source of concern. There is a general feeling there is a high incidence of drug preparations, which are not of acceptable quality (Shakoor, Taylor, and Behrens, 1997). For example, about 70% of counterfeit medicines were reported by developing countries (Helling-Borda, 1995). Reports from Asia, Africa, and South America indicate 10% to 50 % of consider using prescribed drugs in certain countries may be counterfeit (Rudolf, and Bernstein, 2004). For instance, in Nigeria fake medicines may be more than 60 -70% of the drugs in circulation (Osibo, 1998), and 109 children died in 1990 after being administered fake Paracetamol (Alubo, 1994). In Gambia the drug registration and control system resulted in the elimination of ‘drug peddlers’ and certain ‘obsolete and harmful’ drugs, as well as a large decrease in the percentage of brand and combination drugs (Jallow, 1991). The percentage of drugs failed quality control testing was found to be zero in Colombia, but 92% in the private sector of Chad (WHO/DAP, 1996). Hence, it is very difficulty to obtain an accurate data. The proportion of drugs in the USA marketplace are counterfeit is believed to be small - less than 1 percent (Rudolf, and Bernstein, 2004). (Andalo, 2004) reported two cases of counterfeit medicines found their way into legitimate medicine supply chain in the UK in 2004. Poor quality drug preparations may lead to adverse clinical results both in terms of low efficacy and in the development of drug resistance (Shakoor, Taylor, and Behrens, 1997). Regulations are the basic devices employed by most governments to protect the public health against substandard, counterfeit, low quality medicines, and to control prices. Thus, thorough knowledge of whether these regulations produce the intended effects or generate unexpected adverse consequences is therefore critical. The World Health Organisation (WHO) undertook a number of initiatives to improve medicines quality in its member states and promote global mechanisms for regulating the quality of pharmaceutical products in the international markets. But, there aren’t any WHO guidelines on how to evaluate the impact of these regulations. There are numerous reports concerning drug regulations (Ratanwijitrasin, Soumerai, and Weerasuriya, 2001), but the published work on the impact of these regulations on the quality of medicines moving in the international commerce has been scarce. Findings from most published studies lack comparable quantitative information that would allow for objective judging whether and by how much progress on the various outcomes have been made by the implementation of the pharmaceutical regulations. To ignore evaluations and to implement drug regulation based on logic and theory is to expose society to untried measures in the same way patients were exposed to untested medicines (Ratanwijitrasin, Soumerai, and Weerasuriya, 2001). The present policy of the national health–care system in Sudan is based on ensuring the welfare of the Sudanese inhabitants through increasing national production and upgrading the productivity of individuals. A health development strategy has been formulated in a way that realises the relevancy of health objectives to the main goals of the national development plans. The strategy of Sudan at the national level aims at developing the Primary Health Care (PHC) services in the rural areas as well as urban areas. In Sudan 2567 physicians provide the public health services (554 specialists, 107 medical registrars, 1544 medical officers, 156 dentists, and 206 pharmacists (Gamal and Omer, 2008)). Methods of preventing and controlling health problems are the following: • Promotion of food supply and proper nutrition. • An adequate supply of safe water and basic sanitation. • Maternal and child health-care. • Immunisation against major infectious diseases. • Preventing and control of locally endemic diseases, and • Provision of essential drugs. This will be achieved through a health system consisting of three levels (state, provincial and localities), including the referral system, secondary and tertiary levels. Pharmacy management should be coordinated and integrated with other various aspects of health. The following are recommended: • Community must be the focus of benefits accruing from restructures, legislature to protect community interest on the basis of equity and distribution, handover the assets to the community should be examined; and communities shall encourage the transfer the management of health schemes to a professional entity. • The private sector should be used to mobilise, and strengthen the technical and financial resources, from within and without the country to implement the services, with particular emphasis on utilisation of local resources. • The government should provide the necessary financial resources to guide the process of community management of pharmacy supplies. The government to divert from provision of services and be a facilitator through setting up standards, specifications and rules to help harmonise the private sector and establish a legal independent body by an act of parliament to monitor and control the providers. Government to assist the poor communities who cannot afford service cost, and alleviate social-economic negative aspects of privatisation. • The sector actors should create awareness to the community of the roles of the private sector and government in the provision of health and pharmacy services. • Support agencies assist with the financial and technical support, the training facilities, coordination, development and dissemination of health projects, and then evaluation of projects. The aims and objectives of study The main purpose of this study is to analyse and determine the opinion of a group of pharmacists who are the owners or shareholders in the Sudanese medicine importing companies and their perception concerning the effects of the government’s new Pharmacy, Poisons, Cosmetics and Medical Devices Act has had on the quality of medicines in Sudan. • Increase geographical and economic access to essential medicines in all states (i.e., in both rural and urban areas) to reach at least 80% of the population (currently less than 50% of population have access to essential medicines). • The tax collection from the new business becomes more efficient and will increase after privatisation. The tax revenues could be used to finance other health-care activities. • If the government reserves some shares (not more than 50%) in the new business, then its shares’ profit could be used to finance free medicines project in hospitals outpatients’ clinic, and other exempted medicines e.g., renal dialysis and haemophilic patients treatment. Methods: The study proposal was discussed to identify and improve the quality of medicines in Sudan. The survey was deliberately drug importers biased, as low quality medicines from informal sources will affect their business. Results The following are summarised: Health and Pharmacy Systems The health system in Sudan is characterised by heavily reliance on charging users at the point of access (private expenditure on health is 79.1 percent (WHO, 2004)), with less use of prepayment system such as health insurance. The way the health system is funded, organised, managed and regulated affects health workers' supply, retention, and the performance. Primary Health Care was adopted as a main strategy for health-care provision in Sudan and new strategies were introduced during the last decade, include: • Health area system. • Polio eradication in 1988. • Integrated management of children illness (IMCI) initiative. • Rollback malaria strategy. • Basic developmental need approach in 1997. • Safe motherhood, making pregnancy safer initiative, eradication of harmful traditional practices and emergency obstetrics’ care programmes. The strategy of price liberalisation and privatisation had been implemented in Sudan over the last decade, and has had a positive result on government deficit. The investment law approved recently has good statements and rules on the above strategy in particular to health and pharmacy areas. The privatisation and price liberalisation in healthy fields has to re-structure (but not fully). Availability and adequate pharmacy supplies to the major sectors. The result is that, the present situation of pharmacy services is far better than ten years ago. The government of Sudan has a great experience in privatisation of the public institutions i.e., Sudanese free zones and markets, Sudan telecommunications (Sudatel) and Sudan airlines. These experiences provide good lessons about the efficiency and effectiveness of the privatisation policy. Through privatisation, government is not evading its responsibility of providing health-care to the inhabitants, but merely shifting its role from being a provider to a regulator and standard setter. The drug financing was privatised early in 1992. Currently, the Federal Ministry of Health (FMOH) has privatised certain non-medical services in hospitals such as catering services, security and cleanings. The overall goal of the CMS ownership privatisation is to improve access to essential medicines and other medical supplies in order to improve health status of the inhabitants particularly in far states (e.g., Western and Southern States). Establishment of alternative ownership for the CMS can be achieved by selling the majority of shares to the private sector. This will achieve the following objectives: • High access to essential medicines of good quality and affordable prices to the states’ population and governments. • Efficiency and effectiveness in drug distribution system to avoid the serious pitfalls and incidences that reported during the last ten years in the CMS. • Equity by reaching all remote areas currently deprived from the formal drug distribution channels. • Improvement of the quality and quantity of delivery of medicines to the public health facilities. Privatisation of public pharmaceutical supplies The term privatisation has generally been defined as any process aims to shift functions and responsibilities (totally or partially) from the government to the private. In broader meaning, it refers to restrict government's role and to put forward some methods or policies in order to strengthen free market economy (Aktan, 1995). Privatisation can be an ideology (for those who oppose government and seek to reduce its size, role, and costs, or for those who wish to encourage diversity, decentralisation, and choice) or a tool of government (for those who see the private sector as more efficient, flexible, and innovative than the public sector) ((Kamerman et al., 1989), and (Gormley, 1991)). (Scarpaci, 1991) contends that “the invisible hand of the market is more efficient and responsive to the consumer needs and the public administrative budgets consume large portion of tax monies that could otherwise be used for service delivery”. The emphasis is on improving the efficiency of all public enterprises, whether retained or divested. Privatisation may take many forms including: • The elimination of a public function and its assignment to the private sector for financial support as well as delivery (police, and fire departments, schools, etc.). Opponents characterise this as “load-shedding” (Bendick, 1989). • Deregulation is the elimination of government responsibility for setting standards and rules concerning goods or services (Gormley, 1996 and 1997). • Assets sales are the selling of a public asset (city buildings, sports stadiums) to private firms. • Vouchers are the government provided or financed cards or slips of paper that permit private individuals to purchase goods or services from a private provider (food stamps) or circumscribed list of providers (Kettl, 1995). • Franchising is the establishment of models by the public sector that is funded by government agencies, but implemented by approved private providers. • Contracting is the government financing of services, choice of service provider, and specification of various aspects of the services laid out in contracts with the private-sector organisation that produces or delivers the services. • User fees are the public facilities such as hospitals maximise their income or finance some goods from private sources, either through drug sales or other services. This kind of privatisation is applied in Sudan since early 1990s, as the health financing mechanism (especially for medicines). In Sudan, the government has decided to distance itself from direct involvement in business, and thus to divest most of its interests whether in loss or profit making public enterprises. The public reform programme was set firmly in the context of the broader reforms, which were introduced in 1992. It had become clear the previous policies had delivered very disappointed results. This reform based on the transfer of activities vested with the government institutions to the private sector. It signalled the government intention to reduce its presence in the economy, to reduce the level and scope of public spending and to allow market forces to govern economic activities. Privatisation also forms part of the government strategy of strengthening the role of the private in the development to achieve the vision of the 25 years strategy in which the private sector will be the engine for economic growth. The privatisation started in 1992 by liberalization of local currency, foreign exchange transactions, internal and external trade, prices and health services (e.g., user fee as a mechanism of drug financing and other services). This reform had led to greater reliance on individual initiative and corporate accountability rather than on government as a decision-maker in business matters. The privatisation policy goal is to improve the performance of the public sector companies. So, they can contribute to the growth and the development of the economy by broadens ownerships, participation in management, and stimulation domestic and foreign private investment. The following are the primary objectives, which have been defined in the government’s policy statement on public sector reform: • Improve the operational efficiency of enterprises that are currently in the public sector by exposing business and services to the greatest competition for the benefit of the consumer and the national economy. • Reduce the burden of public enterprises on the government’s budget by spreading the shares’ ownership as widely as possible among the population. • Expand the role of the private sector in the economy (permitting the government to concentrate on the public resources) on its role as provider of basic public services, including health, education, social infrastructure, and to compact the side effects of the privatisation. • Encourage wider participation of the people in the ownership and management of business. In pursuing the primary objectives the privatisation policy aims to transform the performance of most significant enterprises in the public sector and ensure liquidation of all viable and non-viable public enterprises as soon as possible through commercialisation, restructuring and divesture. Public sector reform efforts are thus aimed at reducing government dominance and promoting a larger role for the private sector, while improving government’s use of resources. Movement towards those goals in some countries is supported by components of a structural adjustment loan, which helped initiate the programme and establish the legislative and institutional base. Opponents argue, the original objectives of state ownership were to ensure the corporate sector of the economy was in national hands rather than being controlled by either foreign investors or the minorities that enjoyed business dominance upon independence. A further objective was to use investment in state firms to accelerate development in a situation, in which private sector was reluctant to take risks. Medicines legislation framework in Sudan The availability of medicines in Sudan is controlled on the basis of safety, quality and efficacy. Thus, the government effects control in accordance with the Pharmacy, Poisons, Cosmetics and Medical Devices Act 2001 and its instruments. The Federal or State Departments of Pharmacy (DOP) and directives issued orders. The primary objective of both Federal and States’ Departments of Pharmacy is to safeguard public health by ensuring all medicines and pharmaceuticals on the Sudan market meet appropriate standards of safety, quality and efficacy. The safeguarding of public health is achieved largely through the system of medicines’ registration and licensing of pharmacy premises. The first Pharmacy and Poisons Act was enacted in 1939. This Act had been amended three times since then. In 2001 amendments, cosmetics and medical devices were also brought under its purview. Thus, the name was changed to Pharmacy, Poisons, Cosmetics and Medical Devices Act (hereafter the Act). The Act regulates the compounding, sale, distribution, supply, dispensing of medicines and provides different levels of control for different categories e.g., medicines, poisons, cosmetics, chemicals for medical use and medical devices. The Act makes provision for the publication of regulations and guidelines by the Federal Pharmacy and Poisons Board (FPPB), the pharmaceutical regulatory authority and its executive arm - the Federal General Directorate of Pharmacy (FGDOP). The FGDOP regulates mainly four aspects of medicines use: safety, quality, efficacy and price. Traditionally, governments in many countries, particularly developed nations have attempted to ensure the efficiency, safety, rational prescribing, and dispensing of drugs through pre-marketing registration, licensing and other regulatory requirements (Ratanwijitrasin, Soumerai, and Weerasuriya, 2001). When applying to register the medicine manufacturers and importers are required to furnish the FGDOP with a dossier of information including among others, the indication of the medicine, its efficacy, side effects, contraindication, warnings on usage by high risk groups, price, storage and disposal (MOH, 2001).

Biography

Abdeen M Omer, BSc, MSc, PhD is an Associate Researcher at Occupational Health Administration, Ministry of Health and Social Welfare, Khartoum, Sudan. He has been listed in the book Who’s Who in the World 2005, 2006, 2007 and 2010. He has published over 300 papers in peer-reviewed journals, 200 review articles, 7 books and 150 chapters in books.

Speaker
Abdeen M. Omer / Ministry of Health, Khartoum, Sudan

Abstract

Objectives To evaluate plasma kisspeptin-10 (KP-10) and assess its relation to alteredreproductive hormones in preeclampsia (PE) pregnant women. Design: Cohort study Setting: Primary Health Care Centers, Antenatal Care, and the Department of Obstetrics and Gynecology. PatientsFirst time pregnant women (N=100) at 20 weeks of gestation participated in this study and divided into preeclamtics (N=60) and normotensives (N=40). Intervention(s): Collection of venous blood samples during 2nd and 3rd - trimesters of gestation from both groups. Main Outcome Measuret(s): KP-10, luteinizing hormone (LH), follicle stimulating hormone (FSH), beta- human chorionic gonadotropin (β-HCG), estradiol (E2), and progesterone (PRG). ResultsKisspeptin-10 levels were reduced in PE women compared with normotensive pregnancies.In 2nd trimester, area under ROC curve was 0.662 (P=0.003), positive and negative predictive values were 32.8 and 94.6 and test sensitivity and specificity were 55% and 87.5% respectively. Likewise, in the 3rd trimester, area under ROC curve was 0.747 (P≤0.001) positive and negative predictive values were22.2 and 97.3 and test sensitivity and specificity were83.3% and 67.5%respectively.In the 2nd trimester, plasma KP-10 in normotensive women demonstrated a significant (P<0.01) positive correlation (r = 0.44) with FSH as well as a significant (P<0.01) inverse correlation with E2 and PRG (r = - 0.52, - 0.49, respectively).In PE patients, plasma KP-10 demonstrated a significant (P<0.05) inverse correlation with E2 (r = -0.25).In the 3rd trimester, plasma KP-10 in normotensive women demonstrated a significant (P<0.01) inverse correlation with FSH (r = - 0.49), β-hCG (r = - 0.43), E2 (r = - 0.49), and PRG (r = - 0.488; P<0.05).Likewise, in the same period, plasma KP-10 in PE patients demonstrated significant (P<0.01) inverse correlation with LH (r = - 0.34) and FSH (r = - 0.58), and positively correlated with β-hCG (r = 0.39, P< 0.01). Conclusions Relatively high KP-10 sensitivity with the largest area under the ROC curvesduring 2nd and 3rd trimester of pregnancy, suggesting that is statistically acceptable as a diagnostic screening tool to rule out the PE especially in 3rd trimester. Keywords: estradiol,follicle stimulating hormone, Kisspeptin-10, luteinizing hormone, preeclampsia, progesterone.

Biography

Professor of Physiology – Faculty of Pharmacy-Petra University; teaching human physiology & anatomy courses. 9/2013-9/2014: Professor of Physiology and HOD for Medical Sciences– Faculty of MedicineRoyal University for Medical Colleges- Amman - Jordan An Najah National University award for Scientific Research 2011 Funded research projects from the University of Applied Sciences and Al-Ahliyya Amman University 2009 and 2010 Awarded the dedicated work plaque from the Faculty of Pharmacy -University of Applied Sciences 2008 Australian Research Council Ph.D. scholarship 2005

Speaker
Hisham Al-Matubsi / Petra University,Jordan

Abstract

Toxicovigilance is the active process of identifying and evaluating the toxic risks existing in a community, and evaluating the measures taken to reduce or eliminate them. Herbal medicines are now in great demand in the developing world for primary health care not because they are inexpensive but also for better cultural acceptability, better compatibility with the human body and minimal side effects. However, recent findings indicate that all herbal medicines may not be safe as severe consequences are reported for some herbal drugs. Most herbal products on the market today have not been subjected to drug approval process to demonstrate their safety and effectiveness. Thus, Toxicovigilance can contribute for toxicological screening, quality control and regulation of herbal drugs including hazard identification and risk assessment by providing medically validated data which are often overlooked in the process of risk assessment. Toxicovigilance is a critical evolution, which should be viewed as a useful accompaniment for the analyzing, monitoring and reporting of adverse drug reactions (ADRs) and toxicity of herbal drugs. Quality control for efficacy and safety of herbal products is of utmost importance and debated issue in clinical practice. As pharmacist and researchers continue to explore the safety and effectiveness of herbal medicines, more is learned about both their promises and their pitfalls. At the same time, legislators at the International level should continue to press for effective laws to protect consumers from potentially harmful herbal Medicines.

Biography

Working as Associate Professor & Head, Department of Pharmacology, Oriental University, Indore since 30 September 2013 to till date. Additionally Working as Principal, Diploma in Pharmacy since 20th August 2016 to till date in Oriental University, Indore. Worked as Asst. Professor & Head, Research Cell in Dept. of Pharmacy, Oriental University, Indore since April 2011 to September 2013. Working as Incharge for various inspection like PCI, UGC , AICTE, BCI, NCTE and have the sound knowledge for the preparation of Detailed Project Report (DPR) for starting the D.Pham, B.Pharm, M.Pharm, Ph.D etc. followed by preparation of Ordinance, BOS, Academic council minutes etc. Approved Ph.D Guide in Oriental University, Indore and six students registered under my supervision. Worked as Asst. Professor and Team Leader for Pharm D students for their training in hospitals and research center since July 2009 to March 2011 in PIPSAR & RNS Institute of Pharmaceutical Science & Research, Gwalior (M.P.)-India. Worked as Lecturer in Department of Pharmacology and Toxicology, College of Pharmacy, IPS Academy, Indore (M.P.). Since 27/06/2008 to 18/07/2009

Speaker
Neetesh Kumar Jain / Oriental University, Indore

Abstract

Nermeen Magdy is a demonstrator at pharmaceutics department, faculty of pharmacy, Nahda University Beni-suef, Egypt and reviewer in the journal of Pharmaceutical research (Springer) that has an experience in formulation and evaluation of different dosage forms besides ability of teaching different courses. Foundation is based on phytosome as a nanotechnology advanced preparation that is perfect in interaction with natural active constituents to yield a high entrapment efficiency and high ability of transdermal drug delivery.

Biography

Nermeen Magdy is a demonstrator at pharmaceutics department, faculty of pharmacy, Nahda University Beni-suef, Egypt and reviewer in the journal of Pharmaceutical research (Springer) that has an experience in formulation and evaluation of different dosage forms besides ability of teaching different courses. Foundation is based on phytosome as a nanotechnology advanced preparation that is perfect in interaction with natural active constituents to yield a high entrapment efficiency and high ability of transdermal drug delivery.

Speaker
Nermeen Magdy Abd El-Sater Khalil / Nahda University Beni-suef, Egypt

Abstract

Due to lack of stringent regulations and standards from regulatory authorities, Ayurvedic formulations available in the market are not properly standardized and assessed for their quality. Asava and arishta are very important fermented and commonly used dosage forms of Ayurveda. Information on the quantitative parameters of the ayurvedic fermented preparations is very poor. These formulations contain naturally self generated alcohol that acts as the medium for extraction of active ingredients of the herbs. Hence alcohol content becomes a point of concern as well as important parameter for standardization of the asava and arishta and it becomes important for manufacturers to mention alcohol content on the label. In addition, as per ASU GMP guidelines, it is mandatory to carry out the ethanol content to ensure the quality of the product. However manufacturers escape to comply the guidelines because of complexity, cost and time consuming available methods. Hence there was a need to develop a novel method. This study is intended to develop a simple, efficient, less time consuming, economic and accurate gas chromatography method and estimate the ethanol content in marketed ayurvedic formulations of asava and arishta. The detection was carried out using flame ionization detector. The retention time for ethanol was found to be 1.53min. The correlation coefficient (r2) of ethanol was found to be 0.9990. The limit of detection and limit of quantification was found to be 0.4 and 1.1µg/mL for ethanol. The % ethanol content obtained by the proposed method was found to be between 3.05% and 11.53%.

Biography

Harpreet Grover is pursuing "Assesment of compliance level of ASU GMP guidelines and ethanol content in fermented ayurvedic formulations i.e. Asava and arishta. I have also won first prize by APTI for the best paper in International Conference on Clinical research -2017 at Baba Farid University of Health Sciences, Faridkot, Punjab. I am also a registered pharmacist by punjab government as i have done my graduation in pharmacy. masters in clinical research from Baba Farid University of Health Sciences,Faridkot.

Speaker
Harpreet Grover / Clinical Research from Baba Farid University of Health Sciences,Faridkot

Abstract

The plant Conyza sumatrensis is used in traditional medicine in parts of Africa for the treatment of numerous health ailments like inflammation, skin diseases as well as cancers. Bioassay-guided fractionation of the methanol extract of the leaves of Conyza sumatrensis against breast cancer (MCF-7), lung cancer (NCI-H460) and NIH 3T3 (mouse embryonic fibroblast normal cell line) at 1-250 µg/mL was carried out. Fractions and isolated compounds were as well tested at 1-100 µg/mL and 1-100 µM against the cell lines. Extracts of C.sumatrensis was partitioned into aqueous and chloroform fractions and both fractions were tested for their effects on MCF-7 and NCI-H460. Further chromatographic and biological studies of the active chloroform fraction yielded two compounds whose identities were revealed as Stigmasterol 3-O-beta-D-glucoside (A) and 2, 3-dihydroxylpropyl hexacosanoate (B) through NMR and MS studies. These compounds were observed to give –16.50 ± 0.14 and –21.71 ± 0.23 % cytotoxicities against MCF-7 at 100 µM with GI50 and TGI of 40 ± 0.10, 50 ± 6.0 µM and 22.67 ± 1.33 and 69.33 ±1.33 µM respectively. These compounds were also cytotoxic against NCI-H460 cell lines but less than doxorubicin, the anticancer drug used.The overall results showed that the plant can be used to prevent the proliferation of breast and lung cancer cells and hence justify the ethnomedicinal uses of the plants in treating tumor-related ailments.

Biography

Speaker
Ikpefan Emmanuel / University of Nigeria

Abstract

Abstract Objectives: This study was designed to isolate the active constituents from B. procumbens against methicillin resistant Staphylococcus aureus (MRSA). Methods: Methanol extract of the whole plant of B. procumbens (BPM) was fractionated on escalating polarity; [n-hexane (BPH), ethyl acetate (BPE), n-butanol (BPB) and the residual aqueous fraction (BPA)] and evaluated against MRSA through agar well diffusion method. The activity based isolated compounds were characterized by spectroscopic and with relevant literature. Results: Among the extract/fractions only BPE (40 µg/well) inhibited the growth 6.33±0.57 mm of MRSA. Further fractionation and reverse phase HPLC of BPE yielded two pure compounds (C1 and C2) N-trans-feruloyltyramine and N-trans-feruloyl-4-O-methyldopamine, respectively by spectroscopic analysis. Conclusion: The potential of B. procumbens to inhibit the MRSA provides a scientific rationale for the use of this plant as blood purifier and other infectious conditions. Keywords: Methicillin resistant Staphylococcus aureus (MRSA), alkamides, N-trans-feruloyltyramine, N-trans-feruloyl-4-O-methyldopamine, Boerhavia procumbens

Biography

The aim of present study was to investigate the cardioprotective effect of Digera muricata (L) Mart. against the cardiotoxicity induced by acrylamide in rats. Forty eight healthy female albino rats, weighing 190-200 g, divided into eight groups with six rats in each, group I as control, while group II were administered with dimethylsulphoxide (DMSO) 5.0 ml/kg b.w. orally once a day for four weeks. Group III was given 200 mg/kg b.w. of methanolic extract dissolved in DMSO once a day for four weeks. Rest of the rats were divided into five groups and were treated with aqueous solution of acrylamide 6 mg/kg b.w. intraparetoneally once a day for two weeks. Group IV was sacrificed after 15 days of the acrylamide treatment to collect the serum and heart gland. Group V remained untreated as such for the rest of the experiment Group VI, VII and VIII were given 100, 150 and 200 mg/kg b.w. methanolic extract dissolved in DMSO once a day for two weeks. After four weeks all the animals were disected and the blood was collected by cardiac puncture and 5-7 ml blood was taken in falcon tube and was centrifuged to collect the serum and stored at -20şC for biochemical studies. Co-treatment with Digera muricata extract at 100, 150 and 200 mg/kg prevented the elevation of serum marker enzymes creatinine kinase (CK), cardiac creatinine kinase (CK-MB), lactate dehydrogenase (LDH), aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), hydrogen peroxidase (H2 O2 ), total cholesterol, LDL and alterations in protein, superoxide dismutase (SOD), peroxidase (POD), catalase (CAT), glutathione (GSH), glutathione-S-transferase (GST), Gluthaione peroxidase (GSHPx), γ-glutamyl transpeptidase (γ- GT), HDL, creatine and urea caused by acrylamide in rats. The protective effect was confirmed by the histological findings and was more prominent at 200 mg/kg. Hence we conclude that methanolic extract of Digera muricata protects against acrylamide induced cardiac toxicity. j

Speaker
Jasia Bokhari / Quaid-i-Azam University, Pakistan

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