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Galli Maria Cristina - - 2012
This paper discusses EU requirements for long term follow up of Advanced Therapy Medicinal Products and how they can be applied to cancer patients treated with Gene Therapy Medicinal Products in the context of clinical trials, as described in a specific guideline issued by Gene Therapy Working Party at the ...
Knöss Werner - - 2012
The European legislation on medicinal products also addresses the medicinal use of products originating from plants. The objective of the legislation is to ensure the future existence of such products and to consider particular characteristics when assessing quality, efficacy, and safety. Two categories are defined: i) herbal medicinal products can ...
Wang Xuan-Bin - - 2012
Liver fibrosis is a common cause of chronic failure of liver function, which is characterized by extracellular matrix accumulation and disruption of normal tissue architecture. Liver fibrosis-dependent mechanisms of hepatocarcinogenesis have drawn much attention. Herbal medicines are one of the strategies against liver fibrosis and a way to prevent hepatocellular ...
Calhoun Anne H - - 2012
As menstrual-related migraine (MRM) has been reported to be longer, more disabling, less responsive to acute therapy, and more prone to recurrence than nonmenstrual migraine attacks, effective preventive strategies are key to their management. Some combined hormonal contraceptives have been suggested as specific preventives for MRM. This article takes a ...
Ruiter Rikje - - 2012
The objective of this study was to analyze to what extent potentially teratogenic medicinal products are dispensed concomitantly with contraceptives. Data on dispensed medicinal products in this population-based study were obtained from the Dutch Foundation for Pharmaceutical Statistics. For over 178 potentially teratogenic medicinal products, concomitant use of contraceptives was ...
Verbeken Gilbert - - 2012
For practitioners at hospitals seeking to use natural (not genetically modified, as appearing in nature) bacteriophages for treatment of antibiotic-resistant bacterial infections (bacteriophage therapy), Europe's current regulatory framework for medicinal products hinders more than it facilitates. Although many experts consider bacteriophage therapy to be a promising complementary (or alternative) treatment ...
López-Vallejo Fabian - - 2012
Analysis of marketed drugs and commercial vendor libraries used in high-throughput screening suggest that the medicinally relevant chemical space may be expanded to unexplored regions. Novel regions of the chemical space can be conveniently explored with structurally unique molecules with increased complexity and balanced physicochemical properties. As a case study, ...
Marion H - - 2012
The International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) is an international tripartite cooperation programme that brings together regulatory authorities and industry representatives from the European Union, Japan and the United States, with Australia, New Zealand and Canada as observers. VICH aims to improve ...
Vuk Tomislav - - 2012
The aim of the study is to present the results and experience in the management of complaints in a transfusion service in order to draw attention to the importance of this segment of quality management and to stimulate publication of other studies on the topic. This study is based on ...
Li Li - - 2012
UDP-glucuronosyltransferases (UGTs) play important roles in the disposition of many drugs and xenobiotics. Herbal medicine, an important group of multicomponent therapeutics, is widely and increasingly used. Drug metabolism of herbal medicine mediated by cytochrome P450s has been extensively studied; however, herbal medicine metabolism mediated by UGTs has not been adequately ...
Liu Chang-Xiao - - 2012
Over the past few years, nanoscale Chinese medicine has become one of focus in modern Chinese medicine research. There is an increasing need for a more systematic study of the basic issues involved in traditional Chinese medicine and a more active participation of researchers in the application area of nanoscale ...
Amadou Hamadoun - - 2012
We undertook a comparative analysis of (peri-)urban livestock production strategies across three West African cities. Using a semi-structured questionnaire, livestock-keeping households (HH) were interviewed in Kano/Nigeria (84 HH), Bobo Dioulasso/Burkina Faso (63 HH) and Sikasso/Mali (63 HH). Questions covered livestock species kept, herd sizes and structure, feeds used, manure management, ...
Vendrell Daniel - - 2012
Erythromycin is an antimicrobial agent recommended for the control and treatment of diseases caused by Gram-positive bacteria. Few studies, however, have determined the metabolic and pharmacokinetic aspects of this antimicrobial agent in fish. The aim of the present study, therefore, was to determine the accumulation and depletion time of erythromycin ...
Massin Sophie - - 2012
This article aims to help resolve the apparent paradox of producers of addictive goods who claim to be socially responsible while marketing a product clearly identified as harmful. It advances that reputation effects are crucial in this issue and that determining whether harm reduction practices are costly or profitable for ...
Havas Karyn A - - 2012
CONTEXT: Brucellosis is endemic in the country of Georgia, with the highest incidence of disease in the east of Georgia, in the Kakheti region - which is also home to the majority of sheep and a large portion of the national cattle herd (two species that are natural hosts of ...
Wong Wendy W - - 2012
The utilization of complementary and alternative medicine has increased tremendously in the last two decades. Herbal products, homeopathic medicines, and dietary supplements are extremely popular and are available without a prescription (which likely contributes to their popularity). Despite their "natural" characteristics, these remedies have the potential to cause bleeding in ...
Fan Tai-Ping - - 2012
BACKGROUND AND AIM: GP-TCM is the first EU-funded Coordination Action consortium dedicated to traditional Chinese medicine (TCM) research. One of the key deliverables of the Work-Package 7 in GP-TCM was to investigate information of the existing requirements for registration of TCM products listed by global regulatory bodies. The paper aims ...
Nielsen T D - - 2012
Studies reporting on how to control Salmonella in cattle herds have mainly been theoretical simulation models or case reports describing control of clinical salmonellosis outbreaks. The objective of this observational study was to investigate which management routines were associated with successful control of Salmonella Dublin in calves in dairy herds ...
Kargo M - - 2012
The economic benefit of crossbreeding has been well known for many years within dairy production. However, in most countries with an intensive dairy production, an extended use of systematic crossbreeding has not occurred. This may be due to the myth that heterosis is expressed mainly in low-producing herds. The aim ...
Heinrichs Jan-Hendrik - - 2012
Non-invasive brain stimulation promises innovative experimental possibilities for psychology and neuroscience as well as new therapeutic and palliative measures in medicine. Because of its good risk-benefit ratio, non-invasiveness and reversibility as well as its low effort and cost it has good chances of becoming a widespread tool in science, medicine ...
Wang Qinggui - - 2012
Beauvericin is a cyclic hexadepsipeptide mycotoxin, which has insecticidal, antimicrobial, antiviral and cytotoxic activities. It is a potential agent for pesticides and medicines. This paper reviews the bioactivity, fermentation and biosynthesis of the fungal product beauvericin.
de Oliveira Luciana Aparecida - - 2012
The furniture ergonomic evaluation was carried out through the use of questionnaires and forms in industries. For the ergonomic product analysis, it was used the methodology "Object Ergonomics - Ergonomic System Technical Reading" (design goals and management actions), and measurements of products. The values achieved were compared with the standard ...
Jiang Hong - - 2012
The use of complementary and alternative medicine (CAM) as a therapy and preventative care measure for cardiovascular diseases (CVD) may prove to be beneficial when used in conjunction with or in place of conventional medicine. However, the lack of understanding of a mechanism of action of many CAMs limits their ...
Klug Bettina - - 2012
Taking into account the complexity and technical specificity of advanced therapy medicinal products: (gene and cell therapy medicinal products and tissue engineered products), a dedicated European regulatory framework was needed. Regulation (EC) No. 1394/2007, the "ATMP Regulation" provides tailored regulatory principles for the evaluation and authorization of these innovative medicines. ...
Romano M - - 2012
Natural medicinal products have been used for millennia for the treatment of several ailments. Although many have been superseded by conventional pharmaceutical approaches, there is currently a resurgence in the interest in natural products by the general public and the use of complementary and alternative medicine is increasing rapidly in ...
McPhee Derek J - - 2012
Molecules start to institute the "Best Paper" award to recognize these outstanding papers in the area of natural products, medicinal chemistry and molecular diversity published in Molecules. We are pleased to announce the first "Molecules Best Paper Award" for 2012. Nominations were selected by the editor-in-chief and selected editorial board ...
- - 2012
The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: Development of monographs ...
Gluud Christian - - 2012
In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe. We conducted a survey in order to identify the national regulatory requirements for major categories of clinical research in ten European ...
Van Wilder Philippe - - 2012
The market authorization procedure for medicinal products for human use is relying on their demonstrated efficacy, safety, and pharmaceutical quality. This applies to all medicinal products whether of chemical or biological origin. Since October 2009, the first advanced therapy medicinal product (ATMP) has been authorized through the centralized procedure. ATMPs ...
Ancans Janis - - 2012
Advanced therapy medicinal products (ATMPs), including cell therapy products, form a new class of medicines in the European Union. Since the ATMPs are at the forefront of scientific innovation in medicine, specific regulatory framework has been developed for these medicines and implemented from 2009. The Committee for Advanced Therapies (CAT) ...
Hackett Allan - - 2012
Many products claiming to promote weight loss are freely available to purchase over the counter and are used by a substantial proportion of the population in many countries, who are often seeking rapid weight loss without long-term lifestyle changes. While there are multiple outlets for these products, surveys in England ...
Zhang Junhua - - 2012
The popularity of herbal medicines has risen worldwide. This increase in usage renders safety issues important. Many adverse events of herbal medicines can be attributed to the poor quality of the raw materials or the finished products. Different types of herbal medicines are associated with different problems. Quality issues of ...
Numerato Dino - - 2011
In the last three decades, medical doctors have increasingly been exposed to management control measures. This phenomenon has been reflected in a number of studies in various disciplines, including sociology, organisation studies, management, and health service research. This article seeks to provide a comprehensive overview of the studies dealing with ...
Ogwang P E - - 2011
Medicinal plants in Uganda and other developing countries have been scientifically demonstrated to have medicinal benefits but few or none have been translated to products for clinical use. Most herbal products developed by local herbalists and sold to the public are not standardized and lack efficacy and safety data to ...
Kupsch Andreas - - 2011
Early postoperative management in deep brain stimulation-treated patients with dystonia differs from that of patients with essential tremor and Parkinson's disease, mainly due to the usually delayed effects of deep brain stimulation and the heterogenous clinical manifestation and etiologies of dystonia. The present chapter summarizes the available data about and ...
Townsend Timothy G - - 2011
Issues surrounding the impact and management of discarded or waste electronic and electrical equipment (WEEE) have received increasing attention in recent years. This attention stems from the growing quantity and diversity of electronic and electrical equipment (EEE) used by modern society, the increasingly rapid turnover of EEE with the accompanying ...
Mandal Manisha Deb - - 2011
Indeed, medicinal importance of honey has been documented in the world's oldest medical literatures, and since the ancient times, it has been known to possess antimicrobial property as well as wound-healing activity. The healing property of honey is due to the fact that it offers antibacterial activity, maintains a moist ...
Eloff J N - - 2011
Three of the factors limiting the rational use of herbal medicine are uncertainty on effectivity, uncertainty on safety and variation in quality of the product. Because many herbal medicines have been used over centuries by indigenous peoples, the safety and effectivity is frequently not such a big concern. With more ...
Broemling Natasha - - 2011
This article reviews (a) risk factors and preoperative considerations of the patient with tracheoesophageal fistula, (b) anesthetic management, including (i) airway management, (ii) induction of anesthesia and monitoring and (iii) postoperative disposition, (c) considerations for concomitant congenital heart disease, (d) considerations for thoracoscopic repair and (e) long-term outcomes and considerations ...
Ciofetta G - - 2010
Gastroesophageal reflux represents a physiological phenomenon in the first year of life. The reflux associated with clinical complications is defined as "gastroesophageal reflux disease" (GERD), that may be esophageal or extra-esophageal, as is for respiratory problems. Nuclear medicine investigations have given an important contribution to the diagnostic assessment and therapeutical ...
Gogia P - - 2010
In recent years successful bronchoscopic management of bronchopleural fistulas (BPFs) by locating its site and then blocking the leaking segment with any of the several agents available has gained recognition. It is now considered as an alternate mode of management of BPF. Here we present a case of non-resolving pneumothorax ...
Ross Andrew S - - 2010
Although the common indications for therapeutic pancreatic endoscopy - management of ductal strictures and calculi - have remained constants, the last decade has witnessed the emergence of several new endoscopic techniques for managing pancreatic disorders. While many of the advances in therapeutic pancreatic endoscopy have paralleled the shift of endoscopic ...
Yoo Kyo-Sang - - 2010
Bile duct stone management has greatly changed in the past 2 decades. Open surgical techniques have mostly been replaced by transoral endoscopic techniques. Routine common bile duct stones can be managed by standard biliary endoscopic sphincterotomy and extraction. Various advanced transoral techniques can also manage most difficult ductal stones. In ...
Lojko Natalia - - 2010
The rules governing the manufacture and trade in medicinal products in the European Union are, to a large extent, harmonized covering almost the entire life cycle of a medicinal product, starting from the conduct of clinical trials (Directive 2001/20, 2005/28), through manufacture (Directive 2003/94), registration, distribution and pharmacovigilance (Directive 2001/83) ...
Shin Ji Hoon - - 2010
An esophagorespiratory fistula (ERF) is an often fatal consequence of esophageal or bronchogenic carcinomas. The preferred treatment is placement of esophageal and/or airway stents. Stent placement must be performed as quickly as possible since patients with ERFs are at a high risk for aspiration pneumonia. In this review, choice of ...
Sarkar Pralay - - 2010
The management of complex bronchopleural fistulas (BPFs) remains a major diagnostic and therapeutic challenge to all chest physicians. Successful management of a fistula revolves around treatment of the associated empyema cavity first. Definitive repair should be accomplished expeditiously to minimize the number of procedures performed. When treatment is protracted, secondary ...
González-Hernández Jessica - - 2010
Esophageal atresia is the most common congenital anomaly of the esophagus in newborns. This review article discusses the incidence, embryological classification, diagnosis and associated anomalies of esophageal atresia. Emphasis is placed in the current guidelines of standard surgical management of this congenital condition.
Katsinelos Panagiotis - - 2009
Management of giant pedunculated polyps can be a challenge for therapeutic endoscopists, mainly because such polyps are not found in commonplace and experience from their management is limited. We describe a novel use of endoclips that induces significant polyp volume reduction, thereby facilitating the endoscopic removal of giant pedunculated polyps.
Walker Robert W M - - 2009
This article looks at the current techniques and equipment recommended for the management of the difficult intubation scenario in pediatric practice. We discuss the general considerations including preoperative preparation, the preferred anesthetic technique and the use of both rigid laryngoscopic and fiberoptic techniques for intubation. The unanticipated scenario is also ...
Tagawa Tsuyoshi - - 2009
Laryngotracheo-esophageal cleft is a rare congenital anomaly that occurs when the trachea and esophagus fail to separate during fetal development. Clinical severity varies greatly in anatomic cleft extent. We report the successful management of the airway of a neonate with type IV laryngotracheo-esophageal cleft for the gastric division surgery by ...
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