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Kim Hyunah H College of Pharmacy, Sookmyung Women's University, Seoul, - - 2014
This study was performed to review studies carried out in Korea reporting toxic reactions to traditional Chinese medicines (TCMs) as a result of heavy metal contamination. PubMed (1966-August 2013) and International Pharmaceutical Abstracts (1965-August 2013) were searched using the medical subject heading terms of "Medicine, Chinese Traditional," "Medicine, Korean Traditional," ...
Dylst Pieter P KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium, Herestraat 49, O&N 2, P.O. Box 521, 3000 Leuven, - - 2014
Italy is among the European countries with the lowest uptake of generic medicines. This paper provides a perspective on the Italian generic medicines retail market. Fast market entrance of generic medicines in Italy is hindered by several factors: the existence of Complementary Protection Certificates in the past, the large market ...
Dylst Pieter P Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Herestraat 49, O&N 2, P.O. Box 521, 3000 Leuven, - - 2014
The market share of generic medicines in France is low compared to other European countries. This perspective paper provides an overview of the generic medicines retail market in France and how the current policy environment may affect the long-term sustainability. Looking at the French generic medicines retail market and the ...
Kroes Burt H BH Medicines Evaluation Board of the Netherlands,. Electronic address: - - 2014
In the European Union a complex regulatory framework is in place for the regulation of (traditional) herbal medicinal products. It is based on the principle that a marketing authorisation granted by the competent authorities is required for placing medicinal products on the market. The requirements and procedures for acquiring such ...
Leopold Christine - - 2014
Objectives: To analyze the impacts of pharmaceutical sector policies implemented to contain country spending during the economic recession - a reference price system in Finland and a mix of policies including changes in reimbursement rates, a generic promotion campaign and discounts granted to the public payer in Portugal - on ...
Maegawa Hikoichiro H Office of OTC/Generic drugs, Pharmaceuticals and Medical Devices Agency, Japan. Electronic address: - - 2014
Kampo medicines are the main traditional herbal medicines in Japan and are classified as pharmaceuticals. They are based on ancient Chinese medicine and have evolved to the Japanese original style over a long period of time. Ethical Kampo formulations are prescribed in general practice by physician under the National Health ...
Claeson Per P Medical Products Agency, P.O. Box 26, 751 03 Uppsala, Sweden. Electronic address: - - 2014
Based on the regulatory requirements on efficacy documentation in the European Union, the herbal medicinal products have been grouped into the following sections: After briefly reviewing the regulatory requirements on efficacy documentation of herbal medicinal products in the European Union, some concluding remarks on the past and future development in ...
van Galen Emiel E PO Box 8275, 3503 RG Utrecht, the Netherlands. Electronic address: - - 2014
Since 2004 the regulatory framework within the European Union has a specific assessment procedure for herbal medicinal products, with a medicinal use based on traditional practice. The main requirement concerning the traditional use is focussed on the period of time for medical use: at least 30 years, including 15 years ...
Peschel Wieland W HMPC secretariat, European Medicines Agency, 7 Westferry Circus, Canary Wharf, London E14 4HB - United Kingdom. Electronic address: - - 2014
The provisions for the simplified registration of traditional herbal medicinal products in the European Union were introduced by Directive 2004/24/sEC amending Directive 2001/83/EC (Chapter 2a) in 2004. Since implementation in the European member states until December 2012 a total of 1015 registrations (traditional use) and 514 authorisations (well-established use) have ...
Towns Alexandra M AM Naturalis Biodiversity Center, Leiden University, Darwinweg 4, P.O. Box 9517, 2300 RA Leiden, The Netherlands. Electronic address: - - 2014
African medicinal plant markets offer insight into commercially important species, salient health concerns in the region, and possible conservation priorities. Still, little quantitative data is available on the trade in herbal medicine in Central Africa. The aim of this study was to identify the species, volume, and value of medicinal ...
Pullirsch Dieter - - 2014
Counterfeit and unapproved medicines are inherently dangerous and can cause patient injury due to ineffectiveness, chemical or biological contamination, or wrong dosage. Growth of the counterfeit medical market in developed countries is mainly attributable to life-style drugs, which are used in the treatment of non-life-threatening and non-painful conditions, such as ...
Chrubasik-Hausmann Sigrun S Institute of Forensic Medicine, University of Freiburg, Albertstr. 9, 79104, Freiburg, - - 2014
The CE marking is a statutory marking for certain products sold within the European Economic Area. Medicinal products with a CE label are not regulated by the European Medicines Agency but are licensed according to the directives of the European Community. We have analysed the proanthocyanin (PAC) content of four ...
Pratt Nicole L - - 2014
Sequence symmetry analysis (SSA) is a potential tool for rapid detection of adverse drug events (ADRs) associated with newly marketed medicines utilizing computerized claims data. SSA is robust to patient specific confounders but it is sensitive to the underlying utilization trends in the medicines of interest. Methods to adjust for ...
Gilardi Daniela D IBD Center, Gastroenterology, IRCCS Humanitas, Rozzano, Milan, - - 2014
The use of complementary and alternative medicine is wide-spread not only in Eastern countries, but also in the Western world. Despite the increasing evidence on the harmful effects induced by several naturopathic/homeopathic products, patients seem to appreciate these remedies, in particular because they consider them to be absolutely safe. This ...
Wonder Michael M Wonder Drug Consulting Pty Ltd, PO Box 470, Cronulla, NSW 2230, - - 2014
New medicines are the lifeblood of the global innovative pharmaceutical industry. Developments in genomics, proteomics, immunology and cellular biology are set to promise a plethora of novel targets for the industry to create and develop innovative new medicines. For a new medicine to fulfill its therapeutic and commercial potential (i.e., ...
Hinsch Michael - - 2014
Medicine price information mechanisms provide an essential tool to countries that seek a better understanding of product availability, market prices and price compositions of individual medicines. To be effective and contribute to cost savings, these mechanisms need to consider prices in their particular contexts when comparing between countries. This article ...
Rubin Mark - - 2014
We believe that no matter where a practice currently is in the EMR process--vetting products or companies to determine what will best meet its needs, implementing the new product just selected, or trying to take maximum advantage of the product already in use--we hope these suggestions, based on our experience, ...
Dylst Pieter P KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Leuven, - - 2014
The use of generic medicines in Spain is traditionally low compared to other European countries, despite efforts of the Spanish government in the past. This paper provides a perspective on the Spanish generic medicines retail market and how the current policy environment may affect the long-term sustainability. The Spanish government's ...
Simões Carla L CL IPC - Institute for Polymers and Composites/I3N, Minho University, Guimarães, - - 2014
Manufacturers have been increasingly considering the implication of materials used in commercial products and the management of such products at the end of their useful lives (as waste or as post-consumer secondary materials). The present work describes the application of the life cycle thinking approach to a plastic product, specifically ...
Farsalinos Konstantinos E KE Onassis Cardiac Surgery Center, Athens, - - 2014
The rapid growth in the use of electronic cigarettes has been accompanied by substantial discussions by governments, international organisations, consumers and public health experts about how they might be regulated. In the European Union they are currently regulated under consumer legislation but new legislation will regulate them under the Tobacco ...
Walsh Jennifer J Jenny Walsh Consulting Ltd, BioCity Nottingham, Pennyfoot Street, Nottingham NG1 1GF United Kingdom. Electronic address: - - 2014
The development of paediatric medicines can be challenging since this is a diverse patient population with specific needs. For example, the toxicity of excipients may differ in children compared to adults and children have different taste preferences. Acceptable palatability of oral paediatric medicinal products is of great importance to facilitate ...
Tsigkos Stelios - - 2014
The use of biomarkers within the procedures of the Committee of Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) is discussed herein. The applications for Orphan Medicinal Product designation in the EU are evaluated at two stages. At the time of orphan designation application, the file undergoes an ...
Zhang Hai-Ping HP 1] State Key Laboratory of Stress Cell Biology, School of Life Sciences, Xiamen University, Xiamen, Fujian, 361102, PR China - - 2014
Today, herb medicines have become the major source for discovery of novel agents in countermining diseases. However, many of them are largely under-explored in pharmacology due to the limitation of current experimental approaches. Therefore, we proposed a computational framework in this study for network understanding of herb pharmacology via rapid ...
Shofuda Ken-Ichi K Global Quality Assurance Department, Takeda Pharmaceutical Company - - 2014
  Global spread of counterfeit medicines is an imminent threat for the patients' safety. Although major targets of counterfeits are still erectile dysfunction (ED) drugs in the industrialized countries, including Japan, anti-cancer agents and some medicines for metabolic syndromes are also being counterfeited and circulated to the market mainly through the ...
Brennan Connie C Connie Brennan, RN, CPSN, CANS, CPC, is currently the Director of Medical Aesthetic Education at the Center for Advanced Aesthetics at Life Time Fitness and President/Founder of Aesthetic Enhancement Solutions, LLC. Connie is a licensed registered nurse in 10 states and has earned advanced certifications in aesthetic injectables, laser resurfacing, skin care, sclerotherapy, and perioperative nursing over the course of 25 years in aesthetic medicine. Connie has worked as an expert alongside the ASPSN task force in creating the first Certified Aesthetic Nurse Specialist - - 2014
Part 2 of this three-part series of articles on becoming an aesthetic provider centers on the steps necessary to build an aesthetic practice. We will discuss the legal (e.g., licensure, scope of practice, malpractice, and documentation) and the business aspects (e.g., "your brand," staff development, networking, marketing, and revenue possibilities) ...
Gerber Leah R - - 2014
Although market-based incentives have helped resolve many environmental challenges, conservation markets still play a relatively minor role in wildlife management. Establishing property rights for environmental goods and allowing trade between resource extractors and resource conservationists may offer a path forward in conserving charismatic species like whales, wolves, turtles, and sharks. ...
Smith Martin D - - 2014
We critique a proposal to use catch shares to manage transboundary wildlife resources with potentially high non-extractive values, and we focus on the case of whales. Because whales are impure public goods, a policy that fails to capture all nonmarket benefits (due to free riding) could lead to a suboptimal ...
Miaskowska-Daszkiewicz Katarzyna - - 2014
Securing the freedoms of the Internal Market by the European Union entails an obligation to implement such mechanisms so that medicinal products placed on the market could be, on the one hand, widely available to the citizens of Member States and, on the other, so that medicinal products could be ...
Pelkonen Olavi O Department of Pharmacology and Toxicology, University of Oulu, Oulu, - - 2014
Research on herbal medicinal products is increasingly published in "Western" scientific journals dedicated primarily to conventional medicines. Publications are concerned mainly not only on the issues of safety and interactions, but also on efficacy. In reviews, a recurring complaint has been a lack of quality studies. In this opinion article, ...
Ricci Alfredo A 0000-0002-6346-0130 Department of Industrial Chemistry "Toso Montanari", School of Science, University of Bologna, V. Risorgimento 4, 40136 Bologna, - - 2014
The application of the most representative and up-to-date examples of homogeneous asymmetric organocatalysis to the synthesis of molecules of interest in medicinal chemistry is reported. The use of different types of organocatalysts operative via noncovalent and covalent interactions is critically reviewed and the possibility of running some of these reactions ...
Davis G G Suspected Adverse Reaction Surveillance Scheme, Veterinary Medicines Directorate, Woodham Lane, New Haw, Surrey KT15 - - 2013
Increase in serious adverse events Increase in reports involving products marketed under the Small Animal Exemption Scheme Decrease in injection site reactions These are some of the results from the surveillance work carried out by the pharmacovigilance unit at the Veterinary Medicines Directorate (VMD), as discussed by Giles Davis and ...
Koski Sari M SM Division of Social Pharmacy, University of Helsinki, Helsinki, - - 2013
The study aim was to explore the progress of legislation relating to herbal medicinal products in the European Union and compare it with the corresponding progress of the legislation in Finland in 1965-2007. The study was carried out using content analysis. Data were searched from publicly available European Union directives ...
- - 2013
Before medicines can be marketed in the UK, they are subject to a system of licensing and the granting of a marketing authorisation that describes the conditions and patient groups for which the medicinal product can be used within the terms of its licence.(1) The licensing process involves an assessment ...
Mammì Maria M Department of Science of Health, School of Medicine, University of Catanzaro and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, - - 2013
Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use and during clinical trials. In the light of the experience acquired and following an assessment by the Commission of the Union system of pharmacovigilance, it has become clear that it is necessary to take measures in order ...
Dodgson Joan E - - 2013
Abstract The importance of breastmilk as a primary preventative intervention is widely known and understood by most healthcare providers. The actions or non-actions that heathcare providers take toward promoting and supporting breastfeeding families make a difference in the success and duration of breastfeeding. Recognizing this relationship, the World Health Organization ...
Calvo Begoña - - 2013
Biosimilars are biological medicines, the active substances of which are highly similar to those of biologics that have already been authorized. As for any other medicine, the applicant of the biosimilar marketing authorization must submit a risk-management plan (RMP)/pharmacovigilance plan. The pharmacovigilance plan should take into account risks identified during ...
Koerber Florian - - 2013
Since the first pioneering scientists explored the potential of using human cells for therapeutic purposes the branch of regenerative medicine has evolved to become a mature industry. The focus has switched from 'what can be done' to 'what can be commercialized'. Timely health economic evaluation supports successful marketing by establishing ...
Osinski Martin M Nephrology/USA, Miami, FL, - - 2013
As one can see, it is not just a matter for you as a nephrology fellow to identify and determine your best options for a career in nephrology, but it is also important to be aware of these factors that will affect your ability to practice medicine and generate satisfactory ...
Adler-Milstein Julia J University of Michigan, School of Information, 4376 North Quad, Ann Arbor, MI 48109. E-mail: - - 2013
Objectives: To examine the impact of the degree of electronic health record (EHR) use and delegation of EHR tasks on clinician productivity in ambulatory settings. Study Design: We examined EHR use in primary care practices that implemented a web-based EHR from athenahealth (n = 42) over 3 years (695 practice-month ...
Flory Egbert E Paul-Ehrlich-Institut, Division of Medical Biotechnology, Langen, - - 2013
Increasing scientific knowledge and technical innovations in the areas of cell biology, biotechnology and medicine resulted in the development of promising therapeutic approaches for the prevention and treatment of human diseases. Advanced therapy medicinal products (ATMPs) reflect a complex and innovative class of biopharmaceuticals as these products are highly research-driven, ...
Picavet Eline - - 2013
The difficulties associated with organising clinical studies for orphan medicinal products (OMPs) are plentiful. Recent debate on the long-term effectiveness of some OMPs, led us to question whether the initial standards for clinical evidence for OMPs, set by the European Medicines Agency (EMA) at the time of marketing authorization, are ...
Swanson Eric - - 2013
The last decade has brought a major challenge to the traditional practice of plastic surgery from corporations that treat plastic surgery as a commercial product and market directly to the public. This corporate medicine model may include promotion of a trademarked procedure or device, national advertising that promises stunning results, ...
Miller Jennifer E - - 2013
This article explores whether the bioethical performance and trustworthiness of pharmaceutical companies can be improved by harnessing market forces through the use of accreditation, certification, or rating. Other industries have used such systems to define best practices, set standards, and assess and signal the quality of services, processes, and products. ...
Smith M V MV International Programs and Product Standards, Center for Veterinary Medicine, Food and Drug Administration, Rockville, Maryland 20855, USA. - - 2013
An effective animal medicine regulatory programme includes a systematic, evidence-based means of documenting the safety and effectiveness of products before they are produced, marketed or used in a particular country or region. The programme must also include adequate monitoring and controls over the use of these substances. It is clearthat ...
Beck Alain - - 2013
In a defining moment for the European Medicines Agency (EMA) and the biopharmaceutical industry, on June 27, 2013 EMA's Committee for Medicinal Products for Human Use adopted a positive opinion for two biosimilar infliximab products (Celltrion's Remsima® and Hospira's Inflectra®), and recommended that they be approved for marketing in the ...
Judd Kyle T - - 2013
: As the number of fellowship trained orthopedic trauma surgeons entering the work force increases, so does the competition for available practice opportunities. The process of finding employment has seemingly become more involved as the relative availability of positions has declined over recent years. In order to manage this new ...
Dylst Pieter - - 2013
Generic medicines offer equally high-quality treatment as originator medicines do at much lower prices. As such, they represent a considerable opportunity for authorities to obtain substantial savings. At the moment, the pharmaceutical landscape is changing and many pharmaceutical companies have altered their development and commercial strategies, combining both originator and ...
Martinez M N - - 2013
Although bioequivalence (BE) concepts date back to the late 1960s, there has been a steady evolution in the tools applied to the assessment of product comparability. Despite these advancements, we continue to face a multitude of unresolved challenges. Several of these challenges are unique to veterinary medicine due to issues ...
Xie Yan-Ming - - 2013
This paper reviewed the situation of regulations and guidelines on post-marketing medicines in the developed countries and in China. The developed countries have accumulated a lot of empirical principles and techniques on postmarketing surveillance (also named pharmacovigilance), therefore, their regulation systems are nearly perfect. In China, the regulations on post-marketing ...
Czerw Aleksandra - - 2013
Similarly to other European countries, the Polish pharmaceutical market is in the phase of maturity characterized by limited speed of increase in sales. In connection with escalation of the competitive struggle, being the result of globalization and development of enterprises producing generic medications, the most important aim for pharmaceutical companies ...
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