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Pharmaceutical Legislation Changes In Europe - EMA and Member States Prepare
Fri, 03 Feb 2012 10:00:00 -0800
Preparations are underway at the European Medicines Agency together with European Member States and the European Commission, for the introduction of the new pharmacovigilance legislation in July this year. The new legislation will represent the biggest change to the legal framework since The Agency was founded in 1995...
Open Innovation Possibilities To Be Explored By Fleming Europe In Amsterdam, 26 - 27 April 2012
Thu, 02 Feb 2012 01:00:00 -0800
Major blockbuster drugs are facing the end of their era and big pharma companies are bracing for the effect in hopes that they will find a solution for their dwindling pipelines. Thus new opportunities and challenges are rising in the practice of open innovation and Fleming Europe will be there to explore them...
2nd Annual Achieving Clinical & Regulatory Excellence In Turkey, The Middle East & North Africa Conference, 11-14 June 2012, Istanbul, Turkey
Wed, 01 Feb 2012 00:00:00 -0800
NextLevel Pharma's "Advancing clinical research in Turkey, the Middle East and North Africa" conference will bring together the local regulators and ethics committees, alongside experienced investigators and study personnel, as well as clinical trial experts from pharma and CROs...
Pharmaceutical And Medical Device Market Access In Key Asian Markets Conference, 3-4 May 2012, Bangkok, Thailand
Tue, 31 Jan 2012 00:00:00 -0800
Asian markets are increasingly the focus of pharmaceutical companies who are looking for new market opportunities beyond the traditional "rich-world" countries who are facing economic stagnation...
Best Practices In Implementing Green Pharmaceutical Manufacturing Conference, 29-30 March 2012, Vienna, Austria
Mon, 30 Jan 2012 00:00:00 -0800
This unique and timely event will highlight how different frameworks and initiatives have succeeded in developing an efficient, environmentally friendly manufacturing process in the pharmaceutical industry...
Shortages Of Anti-Infective Drugs Pose Threat To Public Health And Patient Care
Mon, 23 Jan 2012 01:00:00 -0800
Shortages of key drugs used to fight infections represent a public health emergency and can put patients at risk, according to a review published in Clinical Infectious Diseases and available online*...
Annals of Pharmacotherapy PAP Articles
Obituary: Lawrence Weaver (February)
Tue, 31 Jan 2012 12:25:17 -0800
BOOKS RECEIVED
Tue, 31 Jan 2012 12:25:17 -0800
Rosiglitazone, Myocardial Ischemic Risk, and Recent Regulatory Actions (February)
Bourg, C. A., Bryles Phillips, B. Tue, 31 Jan 2012 12:25:16 -0800
OBJECTIVE:To review the evidence surrounding rosiglitazone and ischemic cardiovascular risk and discuss the Food and Drug Administration (FDA) decision to revise safety information and restrict access to the drug.DATA SOURCES:A literature search was conducted through MEDLINE (1950-January 2012), PubMed (1966-January 2012), and International Pharmaceutical Abstracts (1970-December 2011) using the search terms rosiglitazone and cardiovascular risk. Regulatory documents from the FDA and the Center for Drug Evaluation and Research, as well as reference citations from publications identified, were reviewed.STUDY SELECTION AND DATA EXTRACTION:All articles in English identified from the data sources were evaluated for inclusion.DATA SYNTHESIS:Literature regarding rosiglitazone and ischemic cardiovascular risk has shown inconsistent results. Meta-analyses by the FDA, GlaxoSmithKline, and several independent research groups suggest an increased risk for myocardial infarction (MI), while others have not. Long-term, controlled trials not designed to evaluate cardiovascular outcomes did not find a significant increase in cardiovascular events and had low event rates overall. The RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes in Oral Agent Combination Therapy for Type 2 Diabetes) trial is the only prospective randomized trial to date designed to evaluate cardiovascular outcomes of rosiglitazone; the results were limited because of issues with study design and event adjudication. The only direct comparisons between rosiglitazone and pioglitazone are observational studies in which pioglitazone had a more favorable MI risk profile.CONCLUSIONS:Data involving rosiglitazone and an association with ischemic cardiovascular risk have yielded variable results. The FDA made the decision to restrict access to rosiglitazone in September 2010 by requiring GlaxoSmithKline to submit a risk evaluation and mitigation strategy (REMS). Drug labeling was revised in February 2011, and the rosiglitazone REMS program took full effect inNovember 2011.
Adult Epilepsy
Andrews, C. O. Tue, 31 Jan 2012 12:25:16 -0800
Serum Potassium Influencing Interacting Drugs: Risk-Modifying Strategies Also Needed at Discontinuation (February)
Uijtendaal, E. V., Zwart-van Rijkom, J. E., van Solinge, W. W., Egberts, T. C. Tue, 31 Jan 2012 12:25:16 -0800
BACKGROUND:Although the discontinuation of a medication may have important clinical consequences, there is generally much less attention given to medication surveillance when a drug is stopped than when it is started.OBJECTIVE:To investigate the consequences on serum potassium levels of discontinuing a drug that increases the serum potassium level (PID) and a drug that decreases the serum potassium level (PLD) in patients taking both.METHODS:Patients who were hospitalized in the University Medical Centre Utrecht in 2004-2009 and were using both a PID and a PLD) were included when one of these drugs was discontinued during hospitalization. Serum potassium levels measured before (potassium1) and after (potassium2) discontinuation were compared in patients who stopped the PLD and in patients who stopped the PID.RESULTS:In the group of patients who stopped the PLD (ie, continued the PID), mean serum potassium levels increased 0.19 mEq/L (range -0.9 to 1.8 mEq/L). After discontinuation of the PLD, serum potassium levels increased in 91 (59%) patients. Five patients (3.2%) developed hyperkalemia (potassium2 >5.5 mEq/L). In the group of patients who stopped the PID (ie, continued the PLD), mean serum potassium levels decreased 0.40 mEq/L (range -2.6 to 0.7 mEq/L). Serum potassium levels decreased in 61 (70%) patients after discontinuation of the PID. Fifteen patients (17%) developed hypokalemia (potassium2 <3.5 mEq/L). Results were not influenced by length of stay, age, sex, renal function, and type of medication discontinued.CONCLUSIONS:The effects of serum potassium-influencing drugs need to be monitored not only after starting but also after stopping the medication. The same may hold true for the effects of other drugs. Clinical risk management should therefore focus on the risks not only when new medication is prescribed, but also when medication is stopped.
Obstetrical Opportunities: Will Pharmacy Ever Realize Them? (February)
Ragland, D., Briggs, G. G., Wasik, M., Kelsey, J. J., Ferreira, E., Abe-Fukushima, W., Forinash, A. B., Kelly, B. D., Nageotte, M. P. Tue, 31 Jan 2012 12:25:16 -0800
Based on a survey of the American College of Clinical Pharmacy Women's Health Practice and Research Network and our own experience, the pharmacy profession has limited involvement in obstetric pharmacotherapy. We believe that such involvement in pregnancies with complicated conditions can result in significant improvement of pregnancy outcomes. Moreover, we believe thisinvolvement would be welcomed by the physicians caring for these patients. This commentary documents current obstetrical pharmacy practices and proposes changes for the profession of pharmacy to consider.
Clinical Pharmacology & Therapeutics - Issue - nature.com science feeds<
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Pharmaceutical Legislation Changes In Europe - EMA and Member States Prepare
Fri, 03 Feb 2012 10:00:00 -0800
Preparations are underway at the European Medicines Agency together with European Member States and the European Commission, for the introduction of the new pharmacovigilance legislation in July this year. The new legislation will represent the biggest change to the legal framework since The Agency was founded in 1995...
Open Innovation Possibilities To Be Explored By Fleming Europe In Amsterdam, 26 - 27 April 2012
Thu, 02 Feb 2012 01:00:00 -0800
Major blockbuster drugs are facing the end of their era and big pharma companies are bracing for the effect in hopes that they will find a solution for their dwindling pipelines. Thus new opportunities and challenges are rising in the practice of open innovation and Fleming Europe will be there to explore them...
2nd Annual Achieving Clinical & Regulatory Excellence In Turkey, The Middle East & North Africa Conference, 11-14 June 2012, Istanbul, Turkey
Wed, 01 Feb 2012 00:00:00 -0800
NextLevel Pharma's "Advancing clinical research in Turkey, the Middle East and North Africa" conference will bring together the local regulators and ethics committees, alongside experienced investigators and study personnel, as well as clinical trial experts from pharma and CROs...
Pharmaceutical And Medical Device Market Access In Key Asian Markets Conference, 3-4 May 2012, Bangkok, Thailand
Tue, 31 Jan 2012 00:00:00 -0800
Asian markets are increasingly the focus of pharmaceutical companies who are looking for new market opportunities beyond the traditional "rich-world" countries who are facing economic stagnation...
Best Practices In Implementing Green Pharmaceutical Manufacturing Conference, 29-30 March 2012, Vienna, Austria
Mon, 30 Jan 2012 00:00:00 -0800
This unique and timely event will highlight how different frameworks and initiatives have succeeded in developing an efficient, environmentally friendly manufacturing process in the pharmaceutical industry...
Shortages Of Anti-Infective Drugs Pose Threat To Public Health And Patient Care
Mon, 23 Jan 2012 01:00:00 -0800
Shortages of key drugs used to fight infections represent a public health emergency and can put patients at risk, according to a review published in Clinical Infectious Diseases and available online*...
Annals of Pharmacotherapy PAP Articles
Obituary: Lawrence Weaver (February)
Tue, 31 Jan 2012 12:25:17 -0800
BOOKS RECEIVED
Tue, 31 Jan 2012 12:25:17 -0800
Rosiglitazone, Myocardial Ischemic Risk, and Recent Regulatory Actions (February)
Bourg, C. A., Bryles Phillips, B. Tue, 31 Jan 2012 12:25:16 -0800
OBJECTIVE:To review the evidence surrounding rosiglitazone and ischemic cardiovascular risk and discuss the Food and Drug Administration (FDA) decision to revise safety information and restrict access to the drug.DATA SOURCES:A literature search was conducted through MEDLINE (1950-January 2012), PubMed (1966-January 2012), and International Pharmaceutical Abstracts (1970-December 2011) using the search terms rosiglitazone and cardiovascular risk. Regulatory documents from the FDA and the Center for Drug Evaluation and Research, as well as reference citations from publications identified, were reviewed.STUDY SELECTION AND DATA EXTRACTION:All articles in English identified from the data sources were evaluated for inclusion.DATA SYNTHESIS:Literature regarding rosiglitazone and ischemic cardiovascular risk has shown inconsistent results. Meta-analyses by the FDA, GlaxoSmithKline, and several independent research groups suggest an increased risk for myocardial infarction (MI), while others have not. Long-term, controlled trials not designed to evaluate cardiovascular outcomes did not find a significant increase in cardiovascular events and had low event rates overall. The RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes in Oral Agent Combination Therapy for Type 2 Diabetes) trial is the only prospective randomized trial to date designed to evaluate cardiovascular outcomes of rosiglitazone; the results were limited because of issues with study design and event adjudication. The only direct comparisons between rosiglitazone and pioglitazone are observational studies in which pioglitazone had a more favorable MI risk profile.CONCLUSIONS:Data involving rosiglitazone and an association with ischemic cardiovascular risk have yielded variable results. The FDA made the decision to restrict access to rosiglitazone in September 2010 by requiring GlaxoSmithKline to submit a risk evaluation and mitigation strategy (REMS). Drug labeling was revised in February 2011, and the rosiglitazone REMS program took full effect inNovember 2011.
Adult Epilepsy
Andrews, C. O. Tue, 31 Jan 2012 12:25:16 -0800
Serum Potassium Influencing Interacting Drugs: Risk-Modifying Strategies Also Needed at Discontinuation (February)
Uijtendaal, E. V., Zwart-van Rijkom, J. E., van Solinge, W. W., Egberts, T. C. Tue, 31 Jan 2012 12:25:16 -0800
BACKGROUND:Although the discontinuation of a medication may have important clinical consequences, there is generally much less attention given to medication surveillance when a drug is stopped than when it is started.OBJECTIVE:To investigate the consequences on serum potassium levels of discontinuing a drug that increases the serum potassium level (PID) and a drug that decreases the serum potassium level (PLD) in patients taking both.METHODS:Patients who were hospitalized in the University Medical Centre Utrecht in 2004-2009 and were using both a PID and a PLD) were included when one of these drugs was discontinued during hospitalization. Serum potassium levels measured before (potassium1) and after (potassium2) discontinuation were compared in patients who stopped the PLD and in patients who stopped the PID.RESULTS:In the group of patients who stopped the PLD (ie, continued the PID), mean serum potassium levels increased 0.19 mEq/L (range -0.9 to 1.8 mEq/L). After discontinuation of the PLD, serum potassium levels increased in 91 (59%) patients. Five patients (3.2%) developed hyperkalemia (potassium2 >5.5 mEq/L). In the group of patients who stopped the PID (ie, continued the PLD), mean serum potassium levels decreased 0.40 mEq/L (range -2.6 to 0.7 mEq/L). Serum potassium levels decreased in 61 (70%) patients after discontinuation of the PID. Fifteen patients (17%) developed hypokalemia (potassium2 <3.5 mEq/L). Results were not influenced by length of stay, age, sex, renal function, and type of medication discontinued.CONCLUSIONS:The effects of serum potassium-influencing drugs need to be monitored not only after starting but also after stopping the medication. The same may hold true for the effects of other drugs. Clinical risk management should therefore focus on the risks not only when new medication is prescribed, but also when medication is stopped.
Obstetrical Opportunities: Will Pharmacy Ever Realize Them? (February)
Ragland, D., Briggs, G. G., Wasik, M., Kelsey, J. J., Ferreira, E., Abe-Fukushima, W., Forinash, A. B., Kelly, B. D., Nageotte, M. P. Tue, 31 Jan 2012 12:25:16 -0800
Based on a survey of the American College of Clinical Pharmacy Women's Health Practice and Research Network and our own experience, the pharmacy profession has limited involvement in obstetric pharmacotherapy. We believe that such involvement in pregnancies with complicated conditions can result in significant improvement of pregnancy outcomes. Moreover, we believe thisinvolvement would be welcomed by the physicians caring for these patients. This commentary documents current obstetrical pharmacy practices and proposes changes for the profession of pharmacy to consider.
Clinical Pharmacology & Therapeutics - Issue - nature.com science feeds<
Sites:
Annual PET Pharmacokinetic Course: Course on application of PET to pharmacokinetics, open to professionals in a wide variety of fields. Held at different locations around the world, next is June 2003 in Montreal, Canada.Cytochrome P450: Identification of a novel transcriptional silencer in the protein-coding region of the human cytochrome P450 2C9 gene.
Department of Pharmacology and Toxicology, School of Medicine, University of Puerto Rico: Department of Pharmacology and Toxicology; University of Puerto Rico; Information about the department and the graduate program in Pharmacology and Toxicology., Department of Pharmacology and Toxicology; University of Puerto Rico; Information about the department and the graduate program in Pharm...
Department of Preclinical and Clinical Pharmacology, University of Florence, Italy: Information on research activities in Pharmacology.
Dissolution Solutions Network: Dissolution Solutions Network: Pharmaceutical scientists providing real answers for one another. The latest news, forum, blog and more...
DrugInfo. Searching the Web for Drug Information: A personal Website based on 30-years experience in pharmacology. Provides help to Web browsers in locating the most relevant drug information on the Web.
Elliot Brown Consulting: MedDRA training, products and pharmacovigilance by Dr Elliot Brown Consultancy.Pharmaceutical regulatory affairs, Adverse experiences, adverse events, drug safety surveillance, post marketing surveillance, EMEA, SPMP, MCA ,
FDA Drug Approvals List: Updated weekly as a service by CDER's Division of Data Management and Services.
Institute of Pharmacology University of Bern Switzerland: Information about the institute, its history, research areas and staff.
Institute of Pharmacology, Polish Academy of Sciences: Information about the Institute and its neuropharmacological research, including psychotropic drugs.
Laboratory of Pulmonary Pharmacology: research in human vascular pharmacology, reactivity of bronchial and vascular tissues, role of the eicosanoids and the cholinergic system
New York University Department of Pharmacology: Teaching of medical and graduate students, with research programs in normal growth and differentiation, development and pathology of the nervous system, and mechanisms of normal and abnormal functions of several key hormones.
Novartis Pharma: Here you'll find expert information about diseases, treatments and the full Novartis US product line, and an inside look at where we're headed.
Optimizing a Unimodal Response Function for Binary Variables: Adaptive designs for optimizing a unimodal response function for binary variables.
Ottosen Site for Drug Safety and Pharmacovigilance: Information about drug safety and clinical studies. Includes discussion forum, news and practical information about issues like safety reporting, licensing, contracts, PSUR, E2B, electronic submission.
Pharmacology and Legal Drugs - About.com: Search the power of About's network of topics
Pharmacology-Info.com: Information about pharmacology, toxicology, getting a new drug to market, and FDA approval.
SMR's Case Histories of Drug Discovery: Drug symposium organized by Society for Medicines Research, drug discovery of infliximab, zanamivir, olanzapine, alosetron, leflunomide and celecoxib.
Social Audit - the Antidepressant Web: social audit
The Lycaeum: An Entheogenic Database: The Lycaeum features an entheogen information database, drug experience archive with over 700 reports, search engine which spiders several major drug information sites, psychedelic graphics, transcribed books, community, software, audio, hosted sites, and much more.
The Ones That Stain Blue: Dr. Albert Hofmann
The Virtual Clinical Pharmacologist: Development of inpatient and outpatient anticoagulation and clinical pharmacology services. In conjunction with this we offer several multi-media CD rom products to assist the user in the development of these services. On line lectures are available .
TICTAC: The CD-ROM for drug identification of tablets & capsules
Toxicology-Info.com: Information on toxicology, drug interactions, toxicity and adverse reactions. Part of the ALtruis Biomedical Network.
University of Colorado Health Sciences Center - Department of Pharmacology: Department of Pharmacology and Graduate Program in Pharmacology at the University of Colorado Health Sciences Center at Denver and information about our pharmacology graduate program, curriculum, and research activities in the Pharmacology department. Research interests include: bioinformatics, m...
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