Estudos de medicamentos biosimilares

In Brazil, the registration of new drugs is carried out only when the regulatory agency (Anvisa, acronym in Portuguese) is fully satisfied with the evidence of their quality, efficacy and safety, presented by a pharmaceutical industry that strive for this registration. With the patent expiration, pharmaceutical companies are attracted to produce biological medicines called biosimilar or biogenerics or simply generics, whose approval may result in reduced treatment costs. But it is necessary that the biosimilar be, at least, equally efective and safe and without contaminants in relation to the original. Recent consensus guidelines aim to establish criteria for efcacy and safety of these medicines. Preclinical studies in vitro and in vivo, the origin of raw materials and clinical studies phase I, II and III are recommended for biosimilar medicine registration in the international market. Low molecular weight heparins are found in this situation. In this review we specifcally addressed this type of medicine, which could serve as a benchmark for other biosimilar medicines.

Committees for ethics in research involving human subjects

In Brazil since October 1996 there have been guidelines for research involving human subjects. Now human subjects know when their treatment is part of research. Deceit is no longer tolerated. But is not enough to say we offer an explanation to the potential subject and we offer a choice before he or she is confronted with an informed consent form. As in all professional activity, scientific investigation needs social controls. In Brazil, the ultimate responsibility of an investigation lies on the investigator, but in every institution where research is carried out there is a Committee for Ethics in Research. All Committees are subordinated to the National Commission of Ethics in Research, which is submitted to the Brazilian Institute of Health. During 2005 around 17,000 protocols involving 700,000 human subjects were revised by 475 Committees distributed all over the country. Approximately 7,000 people are now working in these Committees.

Integration of Genomics in Cancer Care

Purpose: The article aims to introduce nurses to how genetics-genomics is currently integrated into cancer care from prevention to treatment and influencing oncology nursing practice. Organizing Construct: An overview of genetics-genomics is described as it relates to cancer etiology, hereditary cancer syndromes, epigenetics factors, and management of care considerations. Methods: Peer-reviewed literature and expert professional guidelines were reviewed to address concepts of genetics-genomics in cancer care. Findings: Cancer is now known to be heterogeneous at the molecular level, with genetic and genomic factors underlying the etiology of all cancers. Understanding how these factors contribute to the development and treatment of both sporadic and hereditary cancers is important in cancer risk assessment, prevention, diagnosis, treatment, and long-term management and surveillance. Conclusions: Rapidly developing advances in genetics-genomics are changing all aspects of cancer care, with implications for nursing practice. Clinical Relevance: Nurses can educate cancer patients and their families about genetic-genomic advances and advocate for use of evidence-based genetic-genomic practice guidelines to reduce cancer risk and improve outcomes in cancer management. © 2013 Sigma Theta Tau International.

Diretrizes de práticas para transferência de tecnologia de gestão entre Clusters industriais

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Acesso vascular definitivo em usuários de hemodiálise: construção e validação de uma escala de conhecimento

Pós-graduação em Enfermagem (mestrado profissional) - FMB

Como se forja o menor: tramas da atenção psicossocial e da proteção social

This essay aims to contribute to discuss public policies of social protection and practice guidelines for psychosocial care. Targeting children and underage adolescents whose documents, even though permeated with egalitarian discourses and promoted actions aimed at the construction of autonomy, continue endorsing welfare guardianship and addressed to the people classified as at-risk through biopolitical, disciplinary and security technologies based on a minority logic. The essay problematizes the ways in which psychology has found legitimacy in practices that eventually looms confinement practices which aspire to move away from, as was evidenced by documents and practices.

Trabalho de campo como contribuição para a disciplina geografia no ensino fundamental: uma leitura em documentos oficiais

Pós-graduação em Geografia - IGCE

Choosing the right journal for your systematic review

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Implantes tipo plataforma modificada: revisión de literatura

The purpose of this revision was to explore the concept of Platform Switching in implantology and its acting in the clinical practice. The concept of platform switching will be considered together with a revision of pertinent literature, with the purpose of providing guidelines based on scientific evidences. The following databases were used: Pubmed, Library Cochrane and ISI in the last 17 years. The inclusion approaches were: clinical articles, laboratorials and of revision on the topic, in English language. 41 articles were selected, using the describers "platform switching dental implants", "platform shifting and dental implants", "expanded platform dental implant". In accordance with this revision, implant them platform switching they present a rate of more favorable bony remodeling that you implant them conventional. This fact seems to be resulting of a group of biological factors and mechanics. The concept of platform switching has important relevance in the aesthetic area.

Pharmaceutical care in Brazilian community pharmacies: knowledge and practice

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

How to progress from discourse to practice? a new agenda for change in medical schools into the next decade

In the context of medical school instruction, the segmented approach of a focus on specialties and excessive use of technology seem to hamper the development of the professional-patient relationship and an understanding of the ethics of this relationship. The real world presents complexities that require multiple approaches. Engagement in the community where health competence is developed allows extending the usefulness of what is learned. Health services are spaces where the relationship between theory and practice in health care are real and where the social role of the university can be revealed. Yet some competencies are still lacking and may require an explicit agenda to enact. Ten topics are presented for focus here: environmental awareness, involvement of students in medical school, social networks, interprofessional learning, new technologies for the management of care, virtual reality, working with errors, training in management for results, concept of leadership, and internationalization of schools. Potential barriers to this agenda are an underinvestment in ambulatory care infrastructure and community-based health care facilities, as well as in information technology offered at these facilities; an inflexible departmental culture; and an environment centered on a discipline-based medical curriculum.