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Human Medicines European Public Assessment Report EPAR Prevenar PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Human Medicines European Public Assessment Report EPAR Prevenar articles that have been published worldwide.
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Biomedical scientists tend to focus on only a small fraction of the proteins encoded by the human genome despite overwhelming genetic evidence that many understudied proteins are important for human disease. One of the best ways to interrogate the function of a protein and to determine its relevance as a drug target is by using a pharmacological modulator, such as a chemical probe or an antibody. If these tools were available for most human proteins, it should be possible to translate the tremendous advance...
TEM-52 extended-spectrum β-lactamases (ESBLs) have been detected in members of the family Enterobacteriaceae isolated from human and non-human reservoirs, mainly in European countries. We hereby report the first draft genome of a multidrug-resistant TEM-52b-positive Escherichia coli isolated from a companion animal in France.
Estimating the tick-borne encephalitis (TBE) infection risk under substantial uncertainties of the vector abundance, environmental condition and human-tick interaction is important for evidence-informed public health intervention strategies. Estimating this risk is computationally challenging since the data we observe, i.e., the human incidence of TBE, is only the final outcome of the tick-host transmission and tick-human contact processes. The challenge also increases since the complex TBE virus (TBEV) tra...
To facilitate regulatory learning, we evaluated similarities and differences in evidence requirements between regulatory and health technology assessment (HTA) bodies of Alzheimer's disease (AD) approved products. The European marketing authorisation application dossiers and European public assessment reports (EPARs) of the licensed AD drugs were screened to identify the phase III randomised controlled trials (RCTs) and outcomes used. We also screened the assessment reports of the National Institute of Hea...
Assignment of expiry date to homeopathic medicines is a subject of important concern to its pharmacists and practitioners. This study compares the regulatory framework for the expiry of homeopathic medicines in four countries: Brazil, Germany, India and the United States.
Although manufactured cigarettes remain the most popular tobacco product worldwide, the use of other products, including little cigar and cigarillo, has been rising in recent years; however, there is a paucity of data on the correlates of current and ever use of cigarillos in Europe. The aim of this study was to explore the extent and determinants of cigarillo use, as well as to describe the cost and affordability of cigarillos across the EU, in light of the current regulatory framework at a European level.
Human-use probiotics have recently been associated with clinical infections and antibiotic resistance transfer, raising public concern over their safety. However, despite their extensive application in aquaculture and animal husbandry, the safety of animal-use probiotics remains poorly described.
The past fifteen years have witnessed a resurgence of interest in vaginal ring technologies for drug delivery applications, mostly driven by the impetus for development of vaginally-administered antiretroviral microbicides to help reduce the high acquisition rates for human immunodeficiency virus (HIV) among Sub-Saharan African women. Currently, the lead candidate microbicide is a 28-day silicone elastomer vaginal ring releasing dapivirine (Ring-004), an experimental non-nucleoside reverse transcriptase inh...
Virtual reality (VR) simulation surgical skills training is well established, but self-directed practice is often associated with a learning curve plateau. In this study, we investigate the effects of structured self-assessment as a means to improve performance in mastoidectomy training.
Seasonal influenza vaccines are frequently reformulated, leading to specific challenges for continuous benefit/risk monitoring. In 2014, the European Medicines Agency started requiring annual enhanced safety surveillance (ESS). This article provides a perspective on ESS studies conducted ever since and aims to map existing initiatives used to monitor adverse events following influenza immunization. Of 11 ESS studies, reporting surveillance data of at least five different vaccine brands during four seasons, ...
Dang-Gui-Shao-Yao-San () and Gui-Zhi-Fu-Ling-Tang () and among the herbal medicines commonly used to treat primary dysmenorrhea with proven record of effectiveness.
CYP enzyme induction is a sensitive biomarker for phenotypic metabolic competence of in vitro test systems; it is a key event associated with thyroid disruption, and a biomarker for toxicologically relevant nuclear receptor-mediated pathways. This paper summarises the results of a multi-laboratory validation study of two in vitro methods that assess the potential of chemicals to induce cytochrome P450 (CYP) enzyme activity, in particular CYP1A2, CYP2B6, and CYP3A4. The methods are based on the use of cryopr...
Dupilumab is the first targeted biologic therapy for the systemic treatment of atopic dermatitis. It is a fully human monoclonal antibody (mAb) directed against the shared alpha subunit of the interleukin (IL)-4-receptor component of the type I and type II receptors, thereby inhibiting IL-4 and IL-13 signaling. Injection site reactions are among the most common adverse effects reported. We herein report the first case of acquired hypersensitivity to Dupixent confirmed by cutaneous allergy testing necessi...
The field of public health genomics has matured in the past two decades and is beginning to deliver genomic-based interventions for health and health care. In the past few years, the terms precision medicine and precision public health have been used to include information from multiple fields measuring biomarkers as well as environmental and other variables to provide tailored interventions. In the context of public health, "precision" implies delivering the right intervention to the right population at th...
A cross sectional comparison of drug use indicators using WHO methodology in primary level hospitals participating in an Auditable Pharmaceutical Transactions and Services program versus non-APTS primary hospitals in Southern Ethiopia.
Ethiopian pharmaceutical sector has been facing inaccessibility and unaffordability to key essential medicines due to medicines diversion from the public to private health care facilities, lack of transparency, poor inventory management, and poor dispensing workflow. In an effort to improve the pharmaceutical sector, the government of Ethiopia in 2011 introduced Auditable Pharmaceutical Transactions and Services program. This study intended to compare drug use indicators in auditable and non-auditable prima...
Coxiella burnetii is a zoonotic pathogen with a worldwide distribution that is responsible for Q fever in humans. It is a highly infectious bacterium that can be transmitted from cattle to humans through the consumption of unpasteurized milk. We report the molecular identification of C. burnetii in raw cow's milk being sold directly for human consumption in Brazil without official inspection or pasteurization. One hundred and twelve samples of raw milk were analysed by real-time quantitative PCR (qPCR), an...
Atmospheric electrical discharge is an extremely powerful natural phenomenon which can have dangerous and lethal effects on the human body. However, there is no evidence to indicate whether and, if so, to what extent the electric current travelling through the body can affect proper pacemaker function.
Vaccination is one of public health's greatest achievements, responsible for saving billions of lives. Yet, 20% of children worldwide are not fully protected, leading to 1·5 million child deaths annually from vaccine-preventable diseases. Millions more people have severe disabling illnesses, cancers, and disabilities stemming from underimmunisation. Reasons for falling vaccination rates globally include low public trust in vaccines, constraints on affordability or access, and insufficient governmental vacc...
Traditional medicines (TMs) adjunctive to conventional medications are widely used for asthma in east-Asia and have gained popularity in western countries.
Rabies is a fatal disease once contracted, and a serious public health problem. Immunisation was unaffordable and inaccessible for most affected people in India. Omesh Bharti's operational research allows us to reduce the unit dose needed for life saving rabies immunoglobulin (RIG) for class 3 rabid animal bites thereby raising hopes that access to this drug will improve. This study also suggests how public health research should question established guidelines that are rooted in impractical biomedicine wit...
To report clinical and radiographic outcomes, rate of complications and influence on spinal alignment on long-term follow-up (FU) of patients who underwent lumbar total disc arthroplasty (TDR), bringing some evidence to determine the profile of the most well-suited patients for TDR.
The shortage of genomic research data in persons of non-European ancestry is impeding our ability to use genomics in the clinical care of non-European individuals. Improved efforts to utilize data on non-European populations will increase the quality of genomic research and the inferences drawn from it for people of all backgrounds.