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12:50 EDT 23rd March 2018 | BioPortfolio

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Showing "Human medicines European public assessment report EPAR Harvoni" PubMed Articles 1–25 of 45,000+

Sources, distribution, bioavailability, toxicity, and risk assessment of heavy metal(loid)s in complementary medicines.

The last few decades have seen the rise of alternative medical approaches including the use of herbal supplements, natural products, and traditional medicines, which are collectively known as 'Complementary medicines'. However, there are increasing concerns on the safety and health benefits of these medicines. One of the main hazards with the use of complementary medicines is the presence of heavy metal(loid)s such as arsenic (As), cadmium (Cd), lead (Pb), and mercury (Hg). This review deals with the charac...

Pregnancy outcomes after maternal use of thiocolchicoside: A case series.

The 2014 report by European Medicines Agency (EMA) restricted the use of thiocolchicoside for all reproductive-age women. In this study, we aim to expand the systematically-collected human data and discuss it within the frame provided by this report.

Current and future cardiovascular disease risk assessment in the European Union: an international comparative study.

Risk assessment is central to primary prevention of cardiovascular disease (CVD), but there remains a need to better understand the use of evidence-based interventions in practice. This study examines: (i) the policies and guidelines for risk assessment in Europe, (ii) the use of risk assessment tools in clinical practice and (iii) the barriers to, and facilitators of, risk assessment.

Contemporary challenges on access to medicines: beyond the UNSG High-Level Panel.

Within the context of the recently released United Nations Secretary-General´s Report of the High-Level Panel on Access to Medicines, the author reviews issues related to the context and discussions on access to medicines and the conflict between trade and health during the last decades. These issues have been relevant and outstanding in Global Health, especially questioning the current system of innovation, R&D and IP protection. Lessons learned from the HLP Report are highlighted and the need to further ...

Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union: A cohort study.

Few medicines have been approved for children, leading to rates of off-label prescribing reported to be as high as 90%. In 2007, the European Union adopted the Paediatric Regulation, which mandates that pharmaceutical companies conduct paediatric studies for all new medicines, unless granted a waiver. We aimed to evaluate the availability of paediatric trial results from studies required under the Paediatric Regulation for new medicines authorised in the EU.

Safe administration of medicines: learning from our mistakes.

This issue of the Dutch Journal of Medicine (NTvG) features a review article by Van der Veen et al. on safe administration of medicines in hospitals. This topic is part of an increased focus on patient safety that started at the beginning of the 21st century, following publication of the renowned report 'To err is human'. Now, almost 20 years later, we are a little disappointed that there is still no set of interventions that can be implemented to guarantee safe administration of medicines in hospitals. Why...

The effect of cardiorespiratory fitness assessment in preventive health checks: a randomised controlled trial.

Poor cardiorespiratory fitness (CRF) increases morbidity and mortality risks. Routine CRF assessment in clinical practice has thus been advocated, but little is known about the effect. In this study, we investigated the effect of CRF assessment on CRF in a preventive health check programme.

Improving the Safety Assessment of Chemicals and Drug Candidates by the Integration of Bio-informatics and Chemoinformatics Data.

The application of read-across and in silico tools for regulatory decision-making has been limited for pharmaceutical compounds to the assessment of genotoxic impurity. In contrast, the broad availability of toxicity data for industrial chemicals has triggered regulatory frameworks for read-across (e.g. ECHA read-across assessment framework), software tools and public databases for an automated process of gap filling for safety assessment framework. This MiniReview provides an overview of the currently exis...

A Public Health Preparedness Logic Model: Assessing Preparedness for Cross-border Threats in the European Region.

Improving preparedness in the European region requires a clear understanding of what European Union (EU) member states should be able to do, whether acting internally or in cooperation with each other or the EU and other multilateral organizations. We have developed a preparedness logic model that specifies the aims and objectives of public health preparedness, as well as the response capabilities and preparedness capacities needed to achieve them. The capabilities, which describe the ability to effectively...

Community Assessment for Public Health Emergency Response (CASPER): An Innovative Emergency Management Tool in the United States.

To demonstrate how inclusion of the Centers for Disease Control and Prevention's Community Assessment for Public Health Emergency Response (CASPER) as a tool in Public Health Preparedness Capabilities: National Standards for State and Local Planning can increase public health capacity for emergency response.

The development of the public and professional policy committee.

Pet-associated Campylobacteriosis: A persisting public health concern.

Campylobacter is regarded as a leading cause of human bacterial gastroenteritis in the United States. We report on a case of laboratory-confirmed Campylobacter jejuni infection in the Commonwealth of Pennsylvania among members of a household living with a laboratory-confirmed but non-speciated Campylobacter-infected puppy. We describe an outbreak of likely dog-associated campylobacteriosis, the risk factors, potential routes of exposure and the clinical features in the exposed family members, which began sh...

Re: Availability of Evidence of Benefits on Overall Survival and Quality of Life of Cancer Drugs Approved by European Medicines Agency: Retrospective Cohort Study of Drug Approvals 2009-2013.

A Right to Access to Emergency Health Care: The European Court of Human Rights Pushes the Envelope.

This article argues that the European Court of Human Rights (ECtHR) seems to have recently acknowledged that there is a right to access to emergency health care in the member states of the Council of Europe. The Chamber of the ECtHR found that a state's failure to design a regulatory framework that guarantees access to health care in emergency situations violates the substantial limb of Article 2 European Convention on Human Rights (ECHR) that protects the right to life. It is argued that the newly establis...

Assessment of informal caregiver's needs by self-administered instruments: a literature review.

Clinicians, researchers and politicians are seeking to better assess caregiver's needs. Challenges exist in broadly implementing this so as to provide appropriate support. The aim of this review was to compile self-administered instruments for assessment of caregiver's needs that are deemed to be scientifically robust.

Availability and affordability of blood pressure-lowering medicines and the effect on blood pressure control in high-income, middle-income, and low-income countries: an analysis of the PURE study data.

Hypertension is considered the most important risk factor for cardiovascular diseases, but its control is poor worldwide. We aimed to assess the availability and affordability of blood pressure-lowering medicines, and the association with use of these medicines and blood pressure control in countries at varying levels of economic development.

What is the future of Public Health Policy within the European Union?

Public procurement of hepatitis C medicines in Brazil from 2005 to 2015.

This paper analyzes the Minister of Health's (MoH) procurement of medicines for hepatitis C from 2005 to 2015. Data sources were the Integrated General Services Administration (SIASG), to estimate annual expenditure for selected medicines of the MoH Clinical Protocols and Therapeutic Guidelines (PCDT) for Hepatitis C. All presentations and strengths recorded on SIASG were included. The unit prices were estimated based on the purchase with the highest volume each year. There was a 159.5 fold increase in expe...

Fake news of baby booms 9months after major sporting events distorts the public's understanding of early human development science.

In France on 27/6/16, Iceland's men's national football team won 2-1, knocking England out of the UEFA European Championship.

A Cost Analysis of the Jan Aushadhi Scheme in India.

Medicines constitute a substantial proportion of out-of-pocket (OOP) expenses in Indian households. In order to address this issue, the Government of India launched the Jan Aushadhi (Medicine for the Masses) Scheme (JAS) to provide cheap generic medicines to the patients ( These medicines are provided through the Jan Aushadhi stores established across the country. The objective of this study was to do a quick assessment for policy-makers regarding the objec...

Development of an on-line solid phase extraction ultra performance liquid chromatography technique coupled to tandem mass spectrometry for quantification of bisphenol S and bisphenol S glucuronide: Applicability to toxicokinetic investigations.

Regulatory measures and public concerns regarding bisphenol A (BPA) have led to its replacement by structural analogues, such as Bisphenol S (BPS), in consumer products. At present, no toxicokinetic investigations have been conducted to assess the factors determining human internal exposure to BPS for subsequent risk assessment. Toxicokinetic studies require reliable analytical methods to measure the plasma concentrations of BPS and its main conjugated metabolite, BPS-glucuronide (BPS-G). An efficient on-li...

Does access to clinical study reports from the European Medicines Agency reduce reporting biases? A systematic review and meta-analysis of randomized controlled trials on the effect of erythropoiesis-stimulating agents in cancer patients.

Since 2010, the European Medicines Agency (EMA) has provided access to clinical study reports (CSRs). We requested CSRs for randomized controlled trials (RCTs) of erythropoiesis-stimulating agents (ESAs) in cancer patients from EMA and identified RCT publications with literature searches. We assessed CSR availability and completeness, the impact of unreported and unpublished data obtained from CSRs on the effects of ESAs on quality of life (QoL) of cancer patients, and discrepancies between data reported in...

A modified Delphi study to determine the level of consensus across the European Union on the structures, processes and desired outcomes of the management of polypharmacy in older people.

Inappropriate use of multiple medicines (inappropriate polypharmacy) is a major challenge in older people with consequences of increased prevalence and severity of adverse drug reactions and interactions, and reduced medicines adherence. The aim of this study was to determine the levels of consensus amongst key stakeholders in the European Union (EU) in relation to aspects of the management of polypharmacy in older people.

A comparison of new drugs approved by the FDA, the EMA, and Swissmedic: an assessment of the international harmonization of drugs.

This study compared the characteristics of new human drugs approved by the Food and Drug Administration (FDA), the European Medicine Agency (EMA), and Swissmedic (SMC) in the period 2007 to 2016.

When is a medicine unwanted, how is it disposed, and how might safe disposal be promoted? Insights from the Australian population.

Objective The aim of the present study was to explore disposal practices of unwanted medicines in a representative sample of Australian adults, compare this with previous household waste surveys and explore awareness of the National Return and Disposal of Unwanted Medicines (RUM) Project.Methods A 10-min online survey was developed, piloted and conducted with an existing research panel of adult individuals. Survey questions recorded demographics, the presence of unwanted medicines in the home, medicine disp...

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