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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 ...
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 ...
Aiuti Alessandro A Gene Therapy Working Party of the Committee for Advanced Therapies, European Medicines Agency, 7 Westferry Circus E14 4HB, London, United Kingdom. - - 2013
In the European Union, the Committee for Advanced Therapies of the European Medicines Agency takes the lead in the scientific assessment for marketing authorization applications for advanced therapy medicinal products, which include gene therapy medicinal products, somatic cell therapy medicinal products, and tissue-engineered products. The Committee for Advanced Therapies also ...
Nutt David J - - 2013
Despite enormous progress in defining, diagnosing and treating mental disorders, EU health systems face a mounting challenge in responding to 'unmet need'. Mental illnesses produce a societal burden that exceeds that for either cancers or cardiovascular conditions. Leveraging advances in science and medicine to make available new innovative medicines is ...
Tremblay Michael - - 2013
The paper begins by asking why there is a market for counterfeit medicines, which in effect creates the problem of counterfeiting itself. Contributing factors include supply chain complexity and the lack of whole-systems thinking. These two underpin the author's view that counterfeiting is a complex (i.e. wicked) problem, and that ...
- - 2013
All prescribers will be familiar with the issues associated with the use of branded and generic 'chemical' medicines.(1) For biological products (e.g. epoetin, filgrastim), a biosmilar medicine is a new biological product that is similar to a medicine that has already been authorised to be marketed in the EU (the ...
Ehmann Falk - - 2013
Over the last three decades many first-generation nanomedicines have successfully entered routine clinical use and it is now important for medicines regulatory agencies to consider the mechanisms needed to ensure safe introduction of 'follow-on' nanomedicine products, 'nanosimilars'. Moreover, drug regulators need to ensure that 'next'-generation nanomedicines enter clinical development and ...
Karadimitriou Nikos - - 2013
This paper explores the transformations of the housebuilding industry under the policy requirement to build on previously developed land (PDL). This requirement was a key lever in promoting the sustainable urban development agenda of UK governments from the early 1990s to 2010 and has survived albeit somewhat relaxed and permutated ...
Xu Juncai - - 2013
As human civilization develops, biomedicine stays robust. Faced with the challenge of Europe Union's Traditional Herbal Medicinal Products Directive, if traditional Chinese medicine (TCM) wants to be still used as one kind of medicine to treat patients, China should be in line with scientific law, that is, each claim that ...
Gottesman Wesley - - 2013
The OR code, which is short for quick response code, system was invented in Japan for the auto industry. Its purpose was to track vehicles during manufacture; it was designed to allow high-speed component scanning. Now the scanning can be easily accomplished via cell phone, making the technology useful and ...
Stahl Stephen M - - 2013
Guidelines for treating various conditions can be helpful in setting practice standards, but the presence of several sets of guidelines from different countries, experts, and settings, written at different times, can also create confusion. Here we provide a "guideline of guidelines" for the treatment of schizophrenia, or "meta-guidelines," which not ...
Street R A - - 2013
ETHNOPHARMACOLOGICAL RELEVANCE: Traditional medicines in the form of plants, animals and/or minerals are used by millions of South Africans. There is currently no data regarding the commonly used mineral elements thus the potential benefits or hazards of such products remain unclear. MATERIALS AND METHODS: Metal and crystalline salts were purchased ...
Tsiftsoglou Asterios S - - 2013
Biologic medicinal products developed via rDNA technology as recombinant protein-based medicines that have been in clinical use since the early 1980s as original biopharmaceuticals have greatly contributed to the therapy of severe metabolic and degenerative diseases. The recent expiration of the data protection or patents for most of them created ...
Wixon Christopher L - - 2013
The shift in employment options for vascular surgeons in the current era of major health care reform is being widely debated. After the decision to seek hospital employment or independent practice, the choice of then practicing in a single-specialty or a multispecialty practice remains a difficult decision. Although the trend ...
Zimmermann Agnieszka - - 2013
On January 1, 2012, the law of 12 May 2011 on the reimbursement of medicines, food products of special nutritional purpose and medicinal products, intended to tighten up the reimbursement system, came into force in Poland. The new legislative act has significantly altered the previous principles of retail marketing of ...
Abraham Ivo - - 2013
A 'biosimilar', or 'similar biological medicinal product', is a biologic agent that is similar in terms of quality, safety and efficacy to an authorized reference biological medicine. Since the expiration of the filgrastim patent in Europe, three agents have received marketing authorization from the EMA: Tevagrastim, Zarzio and Nivestim. Tevagrastim ...
Gemmiti Christopher - - 2013
Guest Editorial of TEB-2011-0678, "Meeting the Need for Regenerative Therapies: Translation-Focused Analysis of US Regenerative Medicine Opportunities in Cardiovascular and Peripheral Vascular Medicine Using Detailed Incidence Data"
Dégardin Klara - - 2013
Medicine counterfeiting is a serious worldwide issue, involving networks of manufacture and distribution that are an integral part of industrialized organized crime. Despite the potentially devastating health repercussions involved, legal sanctions are often inappropriate or simply not applied. The difficulty in agreeing on a definition of counterfeiting, the huge profits ...
O'Connell Kathryn A - - 2013
In recent years an increasing number of public investments and policy changes have been made to improve the availability, affordability and quality of medicines available to consumers in developing countries, including anti-malarials. It is important to monitor the extent to which these interventions are successful in achieving their aims using ...
Kebriaeezadeh Abbas - - 2013
So far, no detailed study of the Iranian pharmaceutical market has been conducted, and only a few studies have analyzed medicine consumption and expenditure in Iran. Pharmaceutical market trend analysis remains one of the most useful instruments to evaluate the pharmaceutical systems efficiency. An increase in imports of medicines, and ...
Cheraghali Abdol Majid - - 2013
Iran in recent decade faced several regional and international sanctions in foreign trade, financial and banking services. Iran national pharmaceutical industry has always played a major role in providing medicines to the Iranian patients. However, following the sanctions it has faced profound difficulties for importing of both finished products and ...
Tsou Hsiao-Hui - - 2013
Recently, biosimilars have attracted much attention from sponsors and regulatory authorities, while patents on early biological products will soon expire in the next few years. The European Medicines Agency (EMEA) of the European Union (EU) published a guideline on similar biological medicinal products for approval of these products in 2005 ...
Csupor Dezs┼Ĺ - - 2013
Classical homeopathy is based on the therapeutic application of highly diluted homeopathic stocks. The indications of such medicines are determined by proving, i.e. by applying the remedies in healthy subjects. However, there are several complex homeopathic medicinal products on the market with approved therapeutic indications. The efficacy of these medicines ...
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