PubMed Journals Articles About "Human Medicines European Public Assessment Report EPAR Prevenar" - Page: 5 RSS

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Showing "Human medicines European public assessment report EPAR Prevenar" PubMed Articles 101–125 of 44,000+

Target 2035: probing the human proteome.

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...

Genomic characterization of a multidrug-resistant TEM-52b extended-spectrum β-lactamase-positive Escherichia coli ST219 isolated from a cat in France.

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.

Assessing systemic and non-systemic transmission risk of tick-borne encephalitis virus in Hungary.

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...

Alignment of European Regulatory and Health Technology Assessments: A Review of Licensed Products for Alzheimer's Disease.

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...

Current Status of Expiry of Homeopathic Medicines in Brazil, Germany, India and the United States: A Critical Review.

 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.

Cost, prevalence and correlates of cigarillo use in 28 European countries in 2017.

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.

National safety survey of animal-use commercial probiotics and its spillover effects from farm to human: an emerging threat to public health.

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.

Development and pharmacokinetics of a combination vaginal ring for sustained release of dapivirine and the protein microbicide 5P12-RANTES.

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...

The effect of structured self-assessment in virtual reality simulation training of mastoidectomy.

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.

Challenges in implementing yearly enhanced safety surveillance of influenza vaccination in Europe: lessons learned and future perspectives.

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, ...

An experimental study of the anti-dysmenorrhea effect of Chinese herbal medicines used in Jin Gui Yao Lue.

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.

Validation of in vitro methods for human cytochrome P450 enzyme induction: Outcome of a multi-laboratory study.

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...

Acquired Hypersensitivity to Dupilumab: First Case Report.

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...

Beyond Public Health Genomics: Can Big Data and Predictive Analytics Deliver Precision Public Health?

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...

Real-time quantitative PCR-based detection of Coxiella burnetii in unpasteurized cow's milk sold for human consumption.

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...

Lightning-induced pacing system malfunction: a case report.

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.

The public health crisis of underimmunisation: a global plan of action.

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 for asthma in children and adults: A systematic review of placebo-controlled studies.

Traditional medicines (TMs) adjunctive to conventional medications are widely used for asthma in east-Asia and have gained popularity in western countries.

Exemplary operational research on an important public health problem.

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...

Total disc replacement for lumbar degenerative disc disease: single centre 20 years experience.

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.

Cannabis: harmless recreation or dangerous drug?

Cannabis in Malta-big business or laxing restrictions?

Horizon Europe: Will new or old European Union take to the field?

Using the Data We Have: Improving Diversity in Genomic Research.

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.

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