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.

Estudo de perfil de dissolução dos medicamentos de referência, genérico e similar contendo cefalexina na forma farmacêutica cápsula

With recent advances in technology and research into drug delivery, the modernization of tests and greater emphasis on the predictability of therapeutic effect by means of in vitro tests, the dissolution test and the study of dissolution profiles are gaining more and more importance. Though introduced initially as a way of characterizing the release profile of poorly soluble drugs, dissolution tests are currently part of pharmacopoeial monographs on almost all the oral solid pharmaceutical forms. The objective of this study was to determine the dissolution profile (percent drug dissolved versus time) of the pioneer brand, generic and similar pharmaceutical capsules containing 500mg cephalexin. Three pharmaceutical brands (reference, generic and similar) were subjected to the dissolution test and in vitro dissolution profiles were recorded. From the results of the dissolution test, it was concluded that the samples met the acceptance criterion, as no difference was observed in the percentage of the drug dissolved in a standard time. The dissolution profile indicated that this medicine, in this pharmaceutical form, dissolves readily (85% of the drug dissolved in 15 minutes) and the curves showed great similarity, suggesting that the 3 brands are pharmaceutically equivalent.

Polimorfismo na produção de medicamentos

Polymorphism can cause quality deviations during the production of medicines and can influence their effectiveness. Therefore, an understanding of this phenomenon and its implications opens a wide field of possibilities to be explored in the pharmaceutical field, including the emergence of new paradigms and tools for the quality assurance of medicines. This paper presents an introduction to basic aspects of the polymorphism phenomenon and its implications for the production and control of medicines, with emphasis on drug polymorphs.

Contaminação das águas por resíduos de medicamentos: Ênfase ao cloridrato de fluoxetina

The objective of this paper was to review data on residues of medical products in aquatic environments and at wastewater treatment plants. Secondarily the paper presents a discussion about the need for a good management of drugs residues and effluents generated by this sector. Bringing the evidences of environmental possible damages reported by ecotoxicity data on the effects of fluoxetine to Vibrio fischeri and H. azteca, aquatic organisms daily exposed to environmental contaminants. From the results we observed that 0.3 mg.l-1 of fluoxetine hidrochloride induced lethality to H. azteca and 30 mg.l-1 reduced the luminescence of Vibrio fischeri. This assay evidenced higher toxicity when we used the generic product.

Intervenções educativas com usuários de medicamentos como estratégias terapêuticas

A review and analysis of the literature on educative interventions (EI) for medicine users was carried out. For this purpose, databases were searched by employing descriptors related to pharmaceutical care, education and health, covering the period from 1997 to early 2011. A set of 21 articles related to EI with medicine users were selected, 18 (85.7%) of which referred to studies on basic health care. The EI most commonly reported in the articles were: talks, group discussions and educative material. The positive outcomes reported were: improvement in quality of life (better acceptance of the disease), economic advantages (reduction in number of medical consultations) and clinical improvement (risk reduction, prevention of complications).

Validação do glicosímetro portátil para avaliação, prescrição e monitoramento do treinamento aeróbio

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

Gestão de desvios técnicos no recebimento de medicamentos na Central de Abastecimento Farmacêutico

Pós-graduação em Pesquisa e Desenvolvimento (Biotecnologia Médica) - FMB

Influência da expectativa do consumidor sobre a aceitação de suco tropical e de cachaça

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Terapêutica medicamentosa em odontologia: antibióticos

Pós-graduação em Odontologia - FOA

Prescrição e decadência nas relações obrigacionais privadas

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Patentes e licenciamentos compulsórios de medicamentos: o marco regulatório internacional e a ação dos países em desenvolvimento

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Ação in vitro do extrato glicólico de gengibre e medicamentos sobre Candida albicans, Enterococcus faecalis, Escherichia coli e sua endotoxina em canais radiculares

Pós-graduação em Odontologia Restauradora - ICT

Processo de prescrição e aplicação de adaptações de acesso ao computador na paralisia cerebral

Pós-graduação em Educação - FFC

Protocolo para prescrição ou adaptação de recursos pedagógicos para alunos com paralisia cerebral

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Processo de prescrição e confecção de recursos de tecnologia assistiva para educação infantil

Pós-graduação em Educação - FFC