{"title":"An Overview on the Third Annual Pharmacovigilance Forum","authors":"I. Magyar","doi":"10.4172/2167-065X.1000E122","DOIUrl":"https://doi.org/10.4172/2167-065X.1000E122","url":null,"abstract":"Pharmacovigilance is the fourth steps (the last phase) in clinical development of the drugs –after the drug is marketed. New prescription drugs are only marketed after carefully controlled clinical trials have shown them to be safe and effective. Farmacovigilance is the postmarketing surveillance and study of ADRs, with the ultimate goal of preventing or minimizing their occurrence. It is a continuous process that involve both health authorities and pharmaceutical industry. It is a necessary interface between therapeutics and clinical epidemiology. The costs (billions of dollars annually) includes collection, compilation, quality control, and analysis of the spontaneus reports. Although it is the ′′poor relative′′ of pharmacology and the ′′bogeyman′′ of the sellers of new drugs, pharmacovigilance is, neverthless, very important component for the rational use of drugs [1-3].","PeriodicalId":10410,"journal":{"name":"Clinical Pharmacology & Biopharmaceutics","volume":"99 1","pages":"1-1"},"PeriodicalIF":0.0,"publicationDate":"2015-12-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85780115","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ryosuke Yamazoe, Y. Nishihata, K. Nakagawa, Hiroki Aoyama, K. Shimoke
{"title":"Genomic Control of Upregulation of GRP78 Expression for Promotion of Neurite Elongation and Attenuation of Cell Death via PKA-Mediated Signaling in PC12 Cells","authors":"Ryosuke Yamazoe, Y. Nishihata, K. Nakagawa, Hiroki Aoyama, K. Shimoke","doi":"10.4172/2167-065X.1000150","DOIUrl":"https://doi.org/10.4172/2167-065X.1000150","url":null,"abstract":"Neurodegeneration occurs due to neuronal cell death and subsequently disrupts neuronal networks. In current medicine, methods for interruption of neuronal cell death and avoidance of disruption of neuronal networks have potential as therapy for neurodegenerative disorders. Development of this therapy requires analysis of the molecular mechanism of neurite extension that leads to network formation. Here, we show that forskolin (fsk), an activator of adenylate cyclase, increases the intracellular cAMP concentration and induces neurite outgrowth in PC12 cells. The effect of fsk on neurite outgrowth was diminished by H89, an inhibitor of protein kinase A (PKA), and by PD98059 and U0126, which are inhibitors of the mitogen-activated protein kinase (MAPK) signaling pathway. With fsk treatment in the presence of tunicamycin, an inducer of cell death, the activity of the glucose-regulated protein 78 (GRP78) promoters was upregulated. Interestingly, this effect was completely abolished by H89 and by PD98059 and U0126. This phenomenon was confirmed using a dominant-negative PKA-expressing PC12 cell line, in which the PKA-mediated signaling pathway was completely eliminated. These lines of evidence suggest that GRP78 promotes neuronal elongation that is regulated by fsk and mediated by PKA.","PeriodicalId":10410,"journal":{"name":"Clinical Pharmacology & Biopharmaceutics","volume":"9 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-11-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88416047","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Decreasing Incidence of Gastric Cancer and H. pylori Infection a 10- Year Study from an Asian Population","authors":"J. Sollano, Karen Estelle C de Lunas, F. Marotta","doi":"10.4172/2167-065X.1000E121","DOIUrl":"https://doi.org/10.4172/2167-065X.1000E121","url":null,"abstract":"Worldwide, cancer of the stomach is the fourth most common cancer and is the second leading cause of cancer deaths. Gastric cancer is common in many regions of Asia and one of the many factors associated with it is the high prevalence of Helicobacter pylori [Hp] infection. Hp has been designated by the WHO as a class 1 (definite) carcinogen and the association between chronic Hp infection and the development of gastric cancer has been established by numerous publications. Up to 76-95% of gastric cancers are associated with Hp infection [1-3]. Among the many factors expressed by Hp, gastric carcinogenesis via the cag A pathway is the most studied. In individuals infected with CagA-positive strains, a meta-analysis of 16 case-control studies showed a further increase in the risk for gastric cancer by 1.64 fold [4] However, due to improved sanitation amidst better living conditions, heightened patients and physician awareness and widespread Hp eradication practices, a decreasing prevalence of Hp infection is observed even in previous high-prevalence regions. We have also noted that the number of patients with gastric cancer consulting our institution, a tertiary academic hospital, has diminished remarkably in the last several decades. Thus, we designed a study to determine the incidence of gastric cancer, as well as, Hp infection over a ten-year period as seen in our tertiary referral center and evaluated the relationship between Hp infection and gastric cancer.","PeriodicalId":10410,"journal":{"name":"Clinical Pharmacology & Biopharmaceutics","volume":"17 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79148878","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Assessing prescribing patterns for the prevention of chemotherapy-induced nausea and vomiting in the National Center for Cancer Care and Research","authors":"M. Zaidan","doi":"10.4172/2167-065X.C1.013","DOIUrl":"https://doi.org/10.4172/2167-065X.C1.013","url":null,"abstract":"Purpose: Chemotherapy is the mainstay of cancer treatment; however, chemotherapy treatment may cause nausea and vomiting, which could cause 25 -50% PRESCRIBING PATTERNS FOR PREVENTION OF CHEMOTHERAPY INDUCED NAUSEA AND VOMITING 3 of patients to consider delaying or refusing further cancer treatment. Chemotherapyinduced nausea and vomiting (CINV), can be prevented in 70-80% of patients with evidence. –based anti-emetic regimen. The purpose of this study is to assess prescribing patterns with regard to prevention of CINV, in the national center for cancer care and research (NCCCR), and develop and implement a standardized evidencebased guideline for the management of CINV. Methods: 25 anti-emetic prescriptions were audited to assess their conformity with either of the published guidelines; Multinational Association of Supportive Care in Cancer (MASCC), American Society of Clinical Oncology (ASCO), or the National Comprehensive Cancer Network (NCCN), to establish baseline data. A multidisciplinary team of clinical pharmacists and oncologists developed and implemented a guideline for the prevention of CINV. The guideline was promoted using a variety of strategies; education, pocket cards, academic detailing and pharmacist intervention. Physician antiemetic orders were audited by pharmacists, to assess their conformity with NCCCR antiemetic guidelines. A data collection form was developed to capture relevant information including; patient demographics, type and emetogenic level of chemotherapy, and the conformity of anti-emetic order with NCCCR guidelines. SPSS statistical software was used to analyze the data. Results: The conformity of anti-emetic physician order with NCCCR anti-emetic guidelines increased from 0% baseline in June 2008 to an average of 60.006% (n=331) by December 2010 and consistently increased reaching 94.3827% (n=792) by December 2013, (p value 0.0002). PRESCRIBING PATTERNS FOR PREVENTION OF CHEMOTHERAPY INDUCED NAUSEA AND VOMITING 4 Conclusion: The introduction of anti-emetic guidelines succeeded in standardizing CINV management, towards an evidence-based approach.","PeriodicalId":10410,"journal":{"name":"Clinical Pharmacology & Biopharmaceutics","volume":"45 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90825062","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mst. Marium Begum, K. Biswas, A. Sarker, Tamanna Binte Huq, Abeer Sarwar, Md. Belal Hossain, H. Tarek, Md. Noor A-Alam, Asma Rahman
{"title":"Anticholinesterase and Antioxidant Potentials of a Medicinal Plant Abroma augusta: Implications for the Alternative Treatment Therapy of Cognitive Deficits in Alzheimers disease","authors":"Mst. Marium Begum, K. Biswas, A. Sarker, Tamanna Binte Huq, Abeer Sarwar, Md. Belal Hossain, H. Tarek, Md. Noor A-Alam, Asma Rahman","doi":"10.4172/2167-065X.1000148","DOIUrl":"https://doi.org/10.4172/2167-065X.1000148","url":null,"abstract":"Oxidative stress and low level of neurotransmitter (especially acetylcholine) are main characteristics of Alzheimer’s disease (AD), a progressive neurodegenerative disease. Prolonging the function of acetylcholine by inhibiting acetylcholinesterase or butyrylcholinesterase enzyme and reducing oxidative stress with antioxidants are most effective treatment therapy of AD. Abroma augusta is a well-known medicine plant with a variety of medicinal uses. In this study we examine cholinesterase inhibitory activity as well as antioxidant activity of dried fruit extract including crude methyl extract and its sub fractions (Chloroform fraction, Petroleum ether fraction, Ethyl acetate fraction and aqueous fraction) of A. augusta. Both cholinergic inhibitory activity and antioxidant activity of various fractions suggested that, ethyl acetate fraction are most prominent among all fractions and can be used in symptomatic treatment of AD.","PeriodicalId":10410,"journal":{"name":"Clinical Pharmacology & Biopharmaceutics","volume":"24 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79137972","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Is Kava Safe to Be Used by the Public","authors":"A. Al-Achi","doi":"10.4172/2167-065X.1000E120","DOIUrl":"https://doi.org/10.4172/2167-065X.1000E120","url":null,"abstract":"The use of botanical products in the United States and European countries is extensive. While the original intention of the Dietary Supplements and Health Education Act of 1994 (DSHEA) by the US Congress was to use these products for the purpose of “supplementing” the diet, however many consumers use them for managing their disease states. Among the dietary supplements that have been popular among individuals who suffer from anxiety or insomnia is kava (Piper methysticum Frost F.) (The word “methysticum” is Greek for intoxicant, and “Piper” is for pepper. Taken together, kava is an “intoxicating pepper”) [1]. The herb is native to South Pacific region (Melanesia, Micronesia, Polynesia, and Hawaii) where it has been in use for centuries as a traditional beverage. The natives prepare kava drink by masticating the rhizomes which are further diluted with either coconut milk or water [2]. South Pacific islanders use the drink to connect to their gods and ancestors through religious and ceremonial gatherings, to alleviate fatigue, and as a relaxant [3]. The word kava when used by the natives refers to both the shrub itself and the psychoactive drink that is made from its rhizomes [2]. Kava beverage has a bitter and acrid taste which is known by the natives as ‘awa’ [2].","PeriodicalId":10410,"journal":{"name":"Clinical Pharmacology & Biopharmaceutics","volume":"2 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85065742","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
S. Ayalasomayajula, P. Jordaan, Mbchb, P. Pal, Priyamvada Ch, Ra, D. Albrecht, T. Langenickel, I. Rajman, G. Sunkara
{"title":"Assessment of Drug Interaction Potential between LCZ696, an Angiotensin Receptor Neprilysin Inhibitor, and Digoxin or Warfa rin","authors":"S. Ayalasomayajula, P. Jordaan, Mbchb, P. Pal, Priyamvada Ch, Ra, D. Albrecht, T. Langenickel, I. Rajman, G. Sunkara","doi":"10.4172/2167-065X.1000147","DOIUrl":"https://doi.org/10.4172/2167-065X.1000147","url":null,"abstract":"LCZ696 (sacubitril/valsartan) is a first-in-class angiotensin receptor neprilysin inhibitor that simultaneously inhibits neprilysin and blocks the angiotensin II receptor. LCZ696 has been recently approved for treatment of HF and likely be co-administered with digoxin or warfarin. The drug interaction potential between LCZ696 and digoxin or warfarin was evaluated because of their potentially shared metabolic/elimination pathways. Two separate drug-drug interaction studies were conducted in healthy subjects: LCZ696 200 mg twice daily was co-administered with digoxin 0.25 mg once daily (n=24) and warfarin 25 mg single dose (n=26), respectively. The pharmacokinetic profiles of the LCZ696 analytes (sacubitril, LBQ657 and valsartan), digoxin and R- and S-warfarin, the pharmacodynamic effects of warfarin and the safety and tolerability of the investigational drugs were assessed. The geometric mean ratio (GMR) and 90%confidence interval (90% CI) for Cmax and AUCs of R- and S-warfarin, digoxin, and pharmacologically active LCZ696 analytes were within the bioequivalence range of 0.8-1.25 when co-administered. The GMR and 90% CI of warfarin pharmacodynamics effects were also within 0.8-1.25 range when co-administered with LCZ696. LCZ696 was generally safe and welltolerated when administered alone or in combination with digoxin/warfarin. No drug-drug interaction was observed upon co-administration of LCZ696 with digoxin/warfarin in healthy subjects.","PeriodicalId":10410,"journal":{"name":"Clinical Pharmacology & Biopharmaceutics","volume":"24 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78515326","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Blood brain barrier: Cracking the hard nut","authors":"M. Nounou","doi":"10.4172/2167-065X.C1.011","DOIUrl":"https://doi.org/10.4172/2167-065X.C1.011","url":null,"abstract":"T increase in incidence of brain disease, including cancer is alarming. In the Middle East, the incidence of primary brain cancer and secondary brain metastases originating mainly from breast, lung and/or ovarian cancer is on the rise because of increasing prevalence of these types of cancer. On the other hand, noninvasive drug therapy is hampered by poor access of most drugs to the brain due to the insurmountable blood–brain barrier (BBB). Nanotechnology holds great promise for a non-invasive therapy of severe brain diseases. Indeed, the literature reports provided evidence for enhanced drug transport across the BBB using nanocarriers, especially surface-modified polymeric nanoparticles (NPs).","PeriodicalId":10410,"journal":{"name":"Clinical Pharmacology & Biopharmaceutics","volume":"94 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73298055","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}