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PubMed Journals Articles About "Human Medicines European Public Assessment Report EPAR Buccolam" RSS

00:37 EDT 26th March 2019 | BioPortfolio

Human Medicines European Public Assessment Report EPAR Buccolam 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 Buccolam articles that have been published worldwide.

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Showing "Human medicines European public assessment report EPAR Buccolam" PubMed Articles 1–25 of 44,000+

Estimation of total prescription weights of active pharmaceutical ingredients in human medicines based on a public database for environmental risk assessment in Japan.

The distribution of active pharmaceutical ingredients (APIs) in prescription medicines for human consumption in Japan was estimated using the public database of the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB). From the latest NDB, 2058 APIs were identified, and the prescription weight exceeded 1 tonne/year for 711 APIs. Of these, 298 APIs were selected for further analysis after removing 413 APIs that were not covered by current environmental risk assessment (ERA...


Recombination hotspots in an extended human pseudoautosomal domain predicted from double-strand break maps and characterized by sperm-based crossover analysis.

The human X and Y chromosomes are heteromorphic but share a region of homology at the tips of their short arms, pseudoautosomal region 1 (PAR1), that supports obligate crossover in male meiosis. Although the boundary between pseudoautosomal and sex-specific DNA has traditionally been regarded as conserved among primates, it was recently discovered that the boundary position varies among human males, due to a translocation of ~110 kb from the X to the Y chromosome that creates an extended PAR1 (ePAR). This e...

Comparing Use of Health Technology Assessment in Pharmaceutical Policy among Earlier and More Recent Adopters in the European Union.

To examine and compare the use of health technology assessment (HTA) for the reimbursement of new medicines in selected European Union member states with decades of experience in the use of HTA and in countries that have used it regularly since 2000.


Impact of Brexit on UK and EU Drug Regulation and Patient Access.

The chronology of U.K. leaving the European Union Is presented together with its implications for medicines regulation, including the move of the European Medicines Agency from London to Amsterdam, The legal and political options for the UK and the EU are discussed, which at the time of writing (October 2018) are both uncertain, Of importance is the response of the pharmaceutical industry and the possible consequences for UK patients, including delays in access to innovative medicines and an increase in dru...

Rapid assessment of enhanced safety surveillance for influenza vaccine.

The enhanced safety surveillance for seasonal influenza vaccines established by the European Medicines Agency is required each season. Therefore, a registry capable of rapidly detecting and evaluating potential new safety concerns is needed. The aim of the study is to demonstrate the effectiveness of the vaccine information system of the Valencia region to make a rapid assessment of the influenza vaccine safety and describe the safety of the two vaccine types used in the 2017/2018 season.

European Medicines Agency-Health Technology Assessment Parallel Consultation Platform: An Industry Perspective.

Storage of prescription veterinary medicines on UK dairy farms: a cross-sectional study.

Prescription veterinary medicine (PVM) use in the UK is an area of increasing focus for the veterinary profession. While many studies measure antimicrobial use on dairy farms, none report the quantity of antimicrobials stored on farms, nor the ways in which they are stored. The majority of PVM treatments occur in the absence of the prescribing veterinarian, yet there is an identifiable knowledge gap surrounding PVM use and farmer decision making. To provide an evidence base for future work on PVM use, data ...

Evolution of Average European Medicine Prices: Implications for the Methodology of External Price Referencing.

There are indications of staggered market entry of medicines in the national markets, with medicines being marketed first in countries with high prices. This study aimed to analyse the availability and evolution of medicine prices in the European Union (EU).

Optimized Medical Product Regulation in Mexico: A Win-Win for Public and Economic Health.

Medicines regulators, while performing a vital public health activity, are often perceived as both negative cost centers for governments and as impediments to innovation and economic development. The Mexican government recently undertook a regulatory optimization program focused on transforming the Mexican medicines regulatory pathway into one that is efficient, value-added, aligned with international norms, resource accountable, and one that protects and promotes public health, while also facilitating econ...

Lost medicines: a longer view of the pharmaceutical industry with the potential to reinvigorate discovery.

It is widely understood that the 1962 Kefauver-Harris Amendment to the Food, Drug and Cosmetics Act ushered in the modern regulation of medicines requiring a combination of safety and efficacy. However, fewer appreciate the amendment was applied retroactively to virtually all medicines sold in the USA. For various reasons, many medicines faded into history. Here, we identify and analyze >1600 medicines (including over-the-counter drugs) and their innovators prior to the enactment of Kefauver-Harris. We repo...

Access to innovative medicines for metastatic melanoma worldwide: Melanoma World Society and European Association of Dermato-oncology survey in 34 countries.

According to data from recent studies from Europe, a large percentage of patients have restricted access to innovative medicines for metastatic melanoma. Melanoma World Society and European Association of Dermato-oncology conducted a Web-based survey on access to first-line recommended treatments for metastatic melanoma by current guidelines (National Comprehensive Center Network, European Society for Medical Oncology [ESMO] and European Organization for Research and Treatment of Cancer/European Association...

Perceptions of Kenyan adults on access to medicines for non-communicable diseases: A qualitative study.

In Kenya, noncommunicable diseases (NCDs) account for 27% of all deaths. Adult Kenyans have an 18% chance of dying prematurely from cancers, diabetes, cardiovascular diseases or chronic respiratory diseases. A Novartis Access Initiative is making medicines available to treat cardiovascular diseases, diabetes, chronic respiratory diseases, and breast cancer in 30 countries, including Kenya. Little is known about patients' perceptions of access to medicines for NCDs in Kenya. The study objective was to unders...

Monitoring evidence on overall survival benefits of anticancer drugs approved by the European Medicines Agency between 2009 and 2015.

The introduction provisional approval strategies increases the approval of anticancer drugs with ambiguous benefit-risk profiles. Thus, in many instances, there is lacking evidence about overall survival (OS) at the time of marketing authorisation. Our objective was to monitor and characterise therapies with ambiguous benefit-risk profiles and identify any postapproval updates on median OS after at least 3 years of approval by the European Medicines Agency (EMA).

The availability, prices and affordability of essential medicines in Malawi: A cross-sectional study.

The Malawian government recently introduced cost-covering consultation fees for self-referral patients in tertiary public hospitals. Previously, patients received medicines free of charge in government-owned health facilities, but must pay elsewhere. Before the government implements a payment policy in other areas of health care, it is important to investigate the prices, affordability and availability of essential medicines in Malawi.

Stock-outs of antiretroviral and tuberculosis medicines in South Africa: A national cross-sectional survey.

HIV and TB programs have rapidly scaled-up over the past decade in Sub-Saharan Africa and uninterrupted supplies of those medicines are critical to their success. However, estimates of stock-outs are largely unknown. This survey aimed to estimate the extent of stock-outs of antiretroviral and TB medicines in public health facilities across South Africa, which has the world's largest antiretroviral treatment (ART) program and a rising multidrug-resistant TB epidemic.

"You've got to breathe, you know" - asthma patients and carers' perceptions around purchase and use of asthma preventer medicines.

To explore influences on patients' purchase and use of asthma preventer medicines and the perceived acceptability of financial incentives via reduced patient co-payments.

An insight into Z-drugs abuse and dependence: an examination of reports to the European Medicines Agency (EMA) database of suspected Adverse Drug Reactions (ADR).

Although originally marketed as safe alternatives to the habit-forming benzodiazepines, growing numbers of zaleplon, zolpidem, and zopiclone ('Z-drugs') clinical concerns relating to their potential of abuse, dependence and withdrawal have been reported overtime.  We aimed here at assessing these issues analysing datasets of Adverse Drug Reactions (ADR) provided by the European Medicines Agency (EMA) through the EudraVigilance (EV) system.

Biosimilar medicines used for cancer therapy in Europe: a review.

This article provides an updated review of the biosimilar medicines approved for cancer therapy in the European Union (EU). First we discuss the most relevant aspects for the development and approval of biosimilar medicines. We then present the oncological biosimilar drugs currently used, which include epoetins (alpha and zeta), filgrastim, and monoclonal antibodies (rituximab, trastuzumab and bevacizumab). Among the clinical applications of biosimilar medicines, cancer therapy remains the main target area ...

HIV in Canada-Surveillance Report, 2017.

Human immunodeficiency virus (HIV) is a global public health issue with an estimated 1.8 million people newly infected in 2017.

The State Scientific Automated Medical Registry, Kazakhstan: an important resource for low-dose radiation health research.

Direct quantitative assessment of health risks following exposure to ionizing radiation is based on findings from epidemiological studies. Populations affected by nuclear bomb testing are among those that allow such assessment. The population living around the former Soviet Union's Semipalatinsk nuclear test site is one of the largest human cohorts exposed to radiation from nuclear weapons tests. Following research that started in the 1960s, a registry that contains information on more than 300,000 individu...

Key enablers and barriers to implementing adaptive pathways in the European setting.

In 2016, the European Medicines Agency (EMA) published the conclusions of its pilot on adaptive pathways, with products in early stages of development still building up to their marketing authorisation. Adaptive pathways rests on three principles: iterative development; gathering evidence through real-life use to supplement clinical trial data; and early engagement of patients, payers and health technology assessment bodies in discussions on a medicine's development. While the pilot has now finished, the pr...

Evaluation of the factor structure of the Canine Behavioural Assessment and Research Questionnaire (C-BARQ) in European Portuguese.

The human-dog relationship is thought to be the oldest domestic animal partnership. These relationships are complex and can become problematic when they become dysfunctional. The most common signs of dysfunctional human-dog partnerships are behaviour problems that, when unidentified and uncorrected, can be a clear danger to both species and the public. The Canine Behavioural Assessment and Research Questionnaire (C-BARQ) is a widely implemented instrument to evaluate dog behaviour proven to be useful across...

Rats can predict aversiveness of Active Pharmaceutical Ingredients.

Taste is crucial for patient acceptability and compliance with prescribed medicines, in particular with pediatric patients. Evaluating the taste of new active pharmaceutical ingredients (APIs) is therefore essential to put in place adequate taste-masking techniques, if needed, which will lead to acceptable palatable formulations. Thus, there is an urgent need to develop and optimize taste assessment methods that could be used at different stages of the drug development process. The aim of this study was to ...

Bacteriological assessment of some vegetables and ready-to-eat salads in Alexandria, Egypt.

Fresh vegetables and ready-to-eat salads (RTES) are essential components of human diet. Despite their benefits, they remain a major public health concern, because they have been implicated in foodborne illness outbreaks in numerous countries.

Lifestyle determinants of behavioural outcomes triggered by direct-to-consumer advertising of prescription medicines: a cross-sectional study.

Direct-to-consumer advertising of prescription medicines encourages individuals to search for or request advertised medicines, can stimulate taking medications rather than making lifestyle behaviour changes, and may target individuals with poorer demographic and socioeconomic status and riskier health-related behaviours. This study thus explored whether responses to medicine advertising vary as a function of lifestyle behaviours, and demographic and socioeconomic factors.


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