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5.
J Leg Med ; 39(2): 177-211, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31503531

RESUMO

The federal government subsidizes the research and development of prescription medications. Thus, a captivating critique of expensive medications is that prices are too high because of taxpayer co-financing. This critique is often framed in terms of "paying-twice"-first for the research and second through the above market pricing of resulting products. Reasonable pricing clauses-which place some kind of pricing limitation on the exercise of license or patent rights governing a federally funded medication-are one proposed policy tool for addressing the pay-twice critique. This article provides increased analytical clarity as well as historical context to present-day debates about the privatization of federally funded research and prescription drug pricing. It makes three arguments. First, despite its pervasiveness and intuitive plausibility, the pay-twice critique is subject to differing interpretations which has important implications for the appropriateness of proposed solutions. Second, despite their initial attractiveness, the costs, necessity, and effectiveness of reasonable pricing clauses render the wisdom of this policy tool uncertain. However, third, given continued interest in reasonable pricing clauses, the NIH's previous experience with such a policy offers some useful lessons.


Assuntos
Custos de Medicamentos/legislação & jurisprudência , Controle de Medicamentos e Entorpecentes/economia , Controle de Medicamentos e Entorpecentes/legislação & jurisprudência , Legislação de Medicamentos/economia , Medicamentos sob Prescrição/economia , Honorários por Prescrição de Medicamentos/legislação & jurisprudência , Custos e Análise de Custo/economia , Custos e Análise de Custo/legislação & jurisprudência , Governo Federal , Financiamento Governamental , National Institutes of Health (U.S.) , Pesquisa Farmacêutica/economia , Pesquisa Farmacêutica/legislação & jurisprudência , Privatização/economia , Privatização/legislação & jurisprudência , Estados Unidos
6.
J Pharm Biomed Anal ; 164: 598-606, 2019 Feb 05.
Artigo em Inglês | MEDLINE | ID: mdl-30469109

RESUMO

Nowadays, Design of Experiments (DoE) approach is a very popular methodology of planning and conducting experiments, where the effect of each tested factor on the studied responses is systematically examined and documented. The results obtained in such manner represent the design space more precisely than in the case of One-Variable-At-Time (OVAT) approach, leading to reliable and comprehensive results, while saving time and resources. Despite such a large increase of interest in this approach recently, its implementation in metabolomics research seems to be limited. Therefore, in this short overview, apart from summarizing some basic concepts of DoE, we wanted to provide a guideline for those who are about to plan metabolomics-related experiments. This overview is divided into four sections. In addition to the first section, which will introduce the history and basics of DoE, second part will provide concise description of the most popular experimental designs. Furthermore, third section will describe examples of DoE application in metabolomics and related studies. We will conclude with fourth section, providing you briefly with opportunities and trends in metabolomics research utilizing experimental design.


Assuntos
Metabolômica/métodos , Pesquisa Farmacêutica/métodos , Projetos de Pesquisa/normas , Guias como Assunto , Metabolômica/economia , Metabolômica/normas , Metabolômica/tendências , Pesquisa Farmacêutica/economia , Pesquisa Farmacêutica/normas , Pesquisa Farmacêutica/tendências , Fatores de Tempo
8.
Pharm Res ; 35(3): 52, 2018 Feb 07.
Artigo em Inglês | MEDLINE | ID: mdl-29417233

RESUMO

In wealthy nations, non-profit drug R&D has been proposed to reduce the prices of medicines. We sought to review the ethical and economic issues concerning non-profit drug R&D companies, and the possible impact that their pricing strategy may have on the innovation efforts from for-profit companies targeting the same segment of the pharmaceutical market. There are two possible approaches to pricing drugs developed by non-profit R&D programs: pricing that maximises profits and "affordable" pricing that reflects the cost of manufacturing and distribution, plus a margin that ensures sustainability of the drug supply. Overall, the non-profits face ethical challenges - due to the lack of resources, they are unable to independently commercialize their products on a large scale; however, the antitrust law does not permit them to impose prices on potential licensees. Also, reduced prices for the innovative products may result in drying the for-profit R&D in the area.


Assuntos
Comércio/ética , Desenvolvimento de Medicamentos/ética , Organizações sem Fins Lucrativos/ética , Pesquisa Farmacêutica/ética , Comércio/economia , Desenvolvimento de Medicamentos/economia , Desenvolvimento de Medicamentos/métodos , Modelos Econômicos , Organizações sem Fins Lucrativos/economia , Pesquisa Farmacêutica/economia , Pesquisa Farmacêutica/métodos
10.
Drugs Today (Barc) ; 53(3): 203-207, 2017 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-28447077

RESUMO

As the political backdrop changes in both the U.S. and Europe, volatility in the pharma industry is beginning to be felt as the sector becomes sensitive to the uncertainty. U.S. President Trump has stated he will pursue an agenda against high U.S. drug prices and is expected to seek to repeal the Affordable Care Act, while in Europe, Brexit casts further unknowns in regulatory authorization procedures, trade and external reference pricing. With these factors in mind, Terrapin's Evidence Europe meeting provided for a very topical discussion on the use of evidence to define and communicate value in healthcare. With a particular focus on real-world evidence, the conference used presentations, panel briefings and roundtable discussions to foster debate on the challenges faced by industry as it negotiates the current fragile environment.


Assuntos
Medicamentos Biossimilares/uso terapêutico , Descoberta de Drogas/legislação & jurisprudência , Indústria Farmacêutica/legislação & jurisprudência , Legislação de Medicamentos , Licenciamento/legislação & jurisprudência , Pesquisa Farmacêutica/legislação & jurisprudência , Formulação de Políticas , Medicamentos Biossimilares/economia , Ensaios Clínicos como Assunto/legislação & jurisprudência , Comércio/legislação & jurisprudência , Custos de Medicamentos/legislação & jurisprudência , Descoberta de Drogas/economia , Descoberta de Drogas/tendências , Indústria Farmacêutica/economia , Indústria Farmacêutica/tendências , Registros Eletrônicos de Saúde/legislação & jurisprudência , Europa (Continente) , Humanos , Legislação de Medicamentos/economia , Legislação de Medicamentos/tendências , Licenciamento/economia , Licenciamento/tendências , Pesquisa Farmacêutica/economia , Pesquisa Farmacêutica/tendências , Estados Unidos
11.
Drugs Today (Barc) ; 53(1): 75-82, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-28387386

RESUMO

During the fourth quarter of 2016, Cortellis Competitive Intelligence had 889 new deals added as part of its ongoing coverage of pharmaceutical licensing activity. This was an increase on both the last quarter (865) but a decrease from the same quarter for the previous year (915). This article will focus on highlighting a number of the most valuable and notable deals forged during the quarter, as well as a selection of deals from some of the most prolific deal makers. An update on milestones, options and terminated deals of significance will also be presented, along with an early outlook on the next quarter's pharmaceutical licensing activity.


Assuntos
Comércio/economia , Indústria Farmacêutica/economia , Drogas em Investigação/economia , Pesquisa Farmacêutica/economia , Apoio à Pesquisa como Assunto/economia , Comércio/tendências , Custos de Medicamentos/tendências , Indústria Farmacêutica/tendências , Humanos , Pesquisa Farmacêutica/tendências , Apoio à Pesquisa como Assunto/tendências , Fatores de Tempo
12.
Expert Rev Anti Infect Ther ; 15(5): 425-433, 2017 05.
Artigo em Inglês | MEDLINE | ID: mdl-28306360

RESUMO

INTRODUCTION: The combination of growing antimicrobial resistance with a dry pipeline has resulted in infections that can no longer be treated. Specific reasons have led to companies' exit from the antibacterial space, however recent incentives are spurring interest to reinvigorate the pipeline. Areas covered: This article summarizes the available information on the discovery, developmental, and regulatory challenges in antibacterial development that have led to disinterest in the space, as well as ongoing incentives such as public-private partnerships and streamlined pathways to mend these challenges and bring new antibiotics to patients in need. Expert commentary: Clinicians should not only understand the reasons for the decline in antibiotic development that have resulted in the dry pipeline, but also the ongoing initiatives in place to build an appropriate supply. Doing so will result in greater appreciation and prudent use of these life-saving drugs when they become available.


Assuntos
Antibacterianos/economia , Descoberta de Drogas/métodos , Indústria Farmacêutica/economia , Farmacorresistência Bacteriana Múltipla , Drogas em Investigação/economia , Pesquisa Farmacêutica/economia , Antibacterianos/síntese química , Antibacterianos/farmacocinética , Infecções Bacterianas/tratamento farmacológico , Ensaios Clínicos como Assunto , Aprovação de Drogas/métodos , Descoberta de Drogas/economia , Indústria Farmacêutica/legislação & jurisprudência , Drogas em Investigação/síntese química , Drogas em Investigação/farmacocinética , Humanos , Pesquisa Farmacêutica/legislação & jurisprudência
17.
Salud Colect ; 11(1): 49-65, 2015 Mar.
Artigo em Espanhol | MEDLINE | ID: mdl-25853830

RESUMO

Since 1931, and especially since the Nuremberg Code of 1947, an increasing number of declarations, regulations, norms, guidelines, laws, resolutions, and rules intended to create conditions for better protection of subjects participating in research studies have been published, although some have meant setbacks in the human rights of vulnerable populations. As such, violations of the dignity of experimental subjects in clinical trials continue. What researchers investigate and how the research is done, the quality and transparency of the data, and the analysis and the publication of results (of both raw and processed data) respond to the financial interests of the pharmaceutical companies, coming into permanent tension with bioethical principles and the needs of society. The active participation of civil society is necessary to make it so that pharmaceutical research, results and applications subordinate economic benefits to the protection of human rights.


Assuntos
Ensaios Clínicos como Assunto/ética , Experimentação Humana/ética , Violações dos Direitos Humanos/ética , Cooperação Internacional , Pesquisa Farmacêutica/ética , Má Conduta Científica/ética , Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/legislação & jurisprudência , Países em Desenvolvimento/economia , Europa (Continente) , Experimentação Humana/legislação & jurisprudência , Violações dos Direitos Humanos/economia , Violações dos Direitos Humanos/legislação & jurisprudência , Humanos , Cooperação Internacional/legislação & jurisprudência , Pesquisa Farmacêutica/economia , Pesquisa Farmacêutica/legislação & jurisprudência , Má Conduta Científica/legislação & jurisprudência , Estados Unidos
18.
Salud Colect ; 11(1): 67-86, 2015 Mar.
Artigo em Espanhol | MEDLINE | ID: mdl-25853831

RESUMO

This article explains the difficulties innovative pharmaceutical firms have in repaying shareholders with attractive dividends. The problem is the result of the expiration of the patents of blockbuster drugs and the difficulties that the firms have in bringing new blockbuster drugs to the market. One of the solutions companies have found has been to accelerate the implementation of clinical trials in order to expedite the commercialization of new drugs. Doing so increases the period in which they can sell drugs at monopoly prices. We therefore discuss how innovative pharmaceutical firms shorten the implementation time of clinical trials in Latin America and the consequences such actions have on the quality of the collected data, the protection of human rights of the subjects of experimentation, and compliance with the ethical principles approved in international declarations.


Assuntos
Ensaios Clínicos como Assunto/ética , Ensaios Clínicos como Assunto/normas , Conflito de Interesses , Indústria Farmacêutica/ética , Pesquisa Farmacêutica/ética , Pesquisa Farmacêutica/normas , Pesquisadores/ética , Ensaios Clínicos como Assunto/economia , Conflito de Interesses/economia , Indústria Farmacêutica/economia , Comitês de Ética em Pesquisa/ética , Comitês de Ética em Pesquisa/normas , Experimentação Humana/ética , Direitos Humanos , Humanos , Consentimento Livre e Esclarecido/ética , América Latina , Patentes como Assunto/ética , Pesquisa Farmacêutica/economia , Pesquisadores/economia
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