Regulamentação Sanitária de Medicamentos

A regulamentação sanitária de medicamentos é uma das oito diretrizes da Política Nacional de Medicamentos. Trata-se da fiscalização e regulamentação de registro de medicamentos e da autorização de funcionamento desde os produtores até o varejo de medicamentos, bem como das restrições àqueles sujeitos a controle especial. A regulamentação sanitária de medicamentos tem como objetivo garantir eficácia, segurança, qualidade e custo aos produtos farmacêuticos. Os estudos clínicos dos medicamentos de Referência, a bioequivalência ou biodisponibilidade relativa e testes de equivalência dos medicamentos similares e genéricos são meios de avaliar a eficácia e a segurança. A qualidade é garantida lote a lote pelas Boas Práticas de Fabricação e Controle dos produtos farmacêuticos e a certificação da empresa pela ANVISA. O custo é avaliado pela câmara técnica de medicamento (CMED), que estabelece os critérios para fixação e ajuste de preços dos produtos farmacêuticos. No pós-registro, a efetividade, segurança e qualidade dos produtos são avaliadas por meio das comprovações exigidas na renovação do registro e, principalmente, pelo programa de farmacovigilância. Palavras-chave: Registro de Produtos. Medicamentos de Referência. Medicamentos Similares. Medicamentos Genéricos. Alteração de Registro de Produtos. ABSTRACT Health Regulations for Drugs The health regulation of drugs is one of eight guidelines issued within the National Drug Policy. It refers to the supervision and regulation of drug registration and the approval of operations, from the manufacturers to the retailers of medicines, as well as the restrictions that apply to drugs under special control. The health regulation of medicines is aimed at controlling the effectiveness, safety, quality and cost of pharmaceutical products. Clinical studies of brand-name (innovator) medicines, bioequivalence or relative bioavailability and the equivalence tests of generic and ‘similar’ brand-name drugs are means used to assess efficacy and safety. Quality is assured on a batch-to-batch basis by compliance with the Good Manufacturing Practices and Control of pharmaceutical products and by the certification of companies offered by ANVISA. The cost of a medicine is assessed by the Technical Chamber of Medicine (CMED), which establishes the criteria for setting and adjusting the prices of pharmaceutical products. After registration, the effectiveness, safety and quality of products are monitored by means of the tests required on renewal of registration and especially by the pharmacovigilance program. Keywords: Product Registration. Original Brand-name Drugs. Similar Drugs. Generic Drugs. Modification of Product Registration.

Uma leitura de 26 poetas hoje / A reading of 26 poetas hoje

Este trabalho procura identificar selecionadas produções poéticas da antologia 26 Poetas Hoje as faces da resistência indicada por Alfredo Bosi no ensaio “Poesia Resistência”. Do “grito de alarme” pessoal de poetas pertencentes a gerações diferentes, emerge uma poesia espontânea, autêntica e, sobretudo, resistente, como produto da renovação da expressão poética, impregnado de afetividades e de intimismo e que incorporou o coloquial e os recursos da grande poesia brasileira desde 22. This reading presents a sample from this anthology and tries to identify in it the faces of resistance indicated by Alfredo Bosi in his essay: “ Poesia Resistência”. In the several manners the poets of different generations chose for their personal cry of alert we find a poetry wich is spontaneous, authentic and, above all, “resistent”. This is due mainly to the renewal of the poetical expression, impregnated with affective ness and intimism, which included colloquial language and devices used by all great Brazilian poetry since the modernism of 1922.

Estudo do potencial de diferenciação de células-tronco mesenquimais equinas oriundas do sangue da medula óssea cultivadas sobre um filme multicamadas de biopolímeros: quitosna, HA e CMC

Pós-graduação em Biologia Geral e Aplicada - IBB

Substratos artificiais melhoram a qualidade da água em sistema de cultivo multitróficos e multiespaciais?

Pós-graduação em Aquicultura - FCAV

Initial height of pasture deferred and utilized in winter and tillering dynamics of signal grass during the following spring

Tillering dynamics during regrowth in the spring (September to December 2009) on signal grass (Brachiaria decumbens cv. Basilisk) pastures deferred in the beginning of April 2009 is evaluated. Four pasture heights were evaluated at the beginning of deferment (10, 20, 30 and 40 cm). The experimental design consisted of completely randomized blocks with two replications. Rise in pasture height at the beginning of deferment decreased the appearance rate, increased the mortality rate and reduced the survival rate, the balance between appearance and mortality and the stability index of the tiller population at the beginning of the spring. Pastures deferred at initial height of 30 and 40 cm presented relatively stable tiller appearance rate between the beginning and end of spring. However, these pastures presented greater mortality rate, lower survival rate, lower balance between appearance and mortality and lower stability index of the tiller population at the beginning of spring when compared to rates at the end of spring. Pastures managed with shorter initial heights (10 and 20 cm) provided more tissue renewal in the subsequent growth season after their utilization in the winter.

Avaliação da imunomarcação de células-tronco tumorais em carcinossarcomas mamários e carcinomas em tumores mistos em cadelas

Cancer stem cells belong to a small population of cells within the tumor with properties of self-renewal and differentiation into other cell types. In this study, the behavior of both portions, mesenchymal and epithelial, was evaluated. Six carcinosarcomas (CSs), 11 carcinomas within mixed tumors (CWMTs) grade I, 11 grade II, and 10 grade III were evaluated. In the epithelial portions of the CS and CWMTs was observed immunostaining for antibodies CD44, CD24, Oct-4 and ALDH-1. In the mesenchymal portions of the CS, in the epithelial portions of CMTs grades II and III no immunostaining for ALDH-1 was found. It was concluded that the tumor stem cells are expressed in equal proportions in the epithelial and mesenchymal portions of the CS. No immunostaining in the mesenchymal portions of well-differentiated CWMTs was seen.

Ambiete de tanque-rede aumenta as interações agressivas e o estresse social na tilápia-do-Nilo

Pós-graduação em Aquicultura - FCAV

Um estudo introdutório da literatura de João Carlos Marinho

Pós-graduação em Letras - FCLAS

Avaliação de diferentes espaçamentos, altura e épocas de poda na cultura do pinhão manso na região de Selvíria-MS

Pós-graduação em Agronomia - FEIS

Isolation, Culture and Differentiation of Buffaloes Bone Marrow Mesenchymal Stem Cells Obtained from the Coxal Tuberosity

Currently, much attention has been devoted to the renewal of knowledge about Stem Cells and Cell Therapy in domestic species. In this sense, the present work aimed to develop a methodology for collecting, processing and cultivation of mesenchymal stem cells obtained from bone marrow of coxal tuberosity in buffaloes. The collection was performed using a Komiyashiki needle, which was introduced in the coxal tuberosity and the bone marrow aspirated into a heparinized syringe with the aid of negative pressure. Directly after collection samples were processed at the laboratory at FMVZ - UNESP. The samples took approximately 32 days to reach 80% confluence, when the first passage and differentiation was performed. To confirm the mesenchymal origin, cells were induced to differentiate into adipogenic and osteogenic lineages. Samples showed morphological changes during differentiation protocol, but not all presented production of extracellular deposits of calcium or intracellular fat droplets, observed after staining with Alizarin Red and Oil Red respectively. Compared with the material obtained from other species and processed in the same laboratory, the primary culture was longer. Therefore, more studies are needed to standardize the age of animals used and to test other inducers of cell differentiation.

Automação do manejo alimentar na engorda de tilápias criadas em tanque-rede

Pós-graduação em Zootecnia - FMVZ

Custo de produção e lucratividade da cultura do amendoim no município de Jaboticabal, São Paulo

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

A perspectiva metodológica da resolução de problemas: um estudo sobre enunciados de situações matemáticas na EJA

In this paper we discuss the importance of a methodological perspective of solving problems as a sustaining process of teaching mathematics situated on the perspective of concept formation. Organizing a significant didactic situation for students imposes the need to study the interaction between them and the teacher and between them and their mathematical knowledge, learning environment in which the mere transmission of content gives way to contextualization, to historicizing and handling of topics from intuitive and everyday situations for the student. Thus, we understand mathematics as a fundamental language for the creation of theoretical thinking as a whole. We made use of documental analysis and classroom situations aiming at the use of instructional procedure related to the resolution of problems with the purpose of overcoming some representations about the process of teaching and learning mathematics which is strongly marked by imitative-repetitive algorithmic procedures. Considering mathematics as an investigation discipline, we point out renewal prospects for the curricula of this discipline, which are concrete in the movement of cultural action of the school itself as the cell generating discussion.

Extracellular matrix remodeling of the testes through the male reproductive cycle in Teleostei fish

During the fish reproductive cycle, testes undergo morphological changes related to germinal epithelium and remodeling of extracellular matrix components (ECM). ECM is degraded mainly by action of matrix metalloproteinases (MMPs). Due to the natural renewal of ECM in fish testes, we choose Pimelodus maculatus to study remodeling of ECM throughout reproductive cycle, using picrosirius (to identify type I, II, III collagen) and reticulin (type III collagen), and to immunolocalize MT1-MMP (membrane type 1-matrix metalloproteinase) and MMP-2 in testis cells. Testes were classified in four reproductive phases: regenerating, development, spawning capable and regressing. Picrosirius and reticulin demonstrated a differential distribution of total collagen fibers during the reproductive cycle. Immunohistochemistry showed MT1-MMP only in acidophilic granulocyte cells mainly inside blood vessels, in connective tissue of capsule close to the germinal compartment, and also infiltrated in interstitial connective tissue. MMP-2 was detected in fibroblast and endothelial cells of interstitial and capsule blood vessels, in epithelial cells of capsule, and in acidophilic granulocyte cells at same description for MT1-MMP. The fish testes ECM were remodeled throughout reproductive cycle in according to morphophysiological alterations. During reproductive season (spawning capable), the interstitium increased in total collagen fibers (type I, II, III). After spermiation period (regression and regenerating), the amount of collagen fibers decreased in response to action of MMPs on collagen degradation and other interstitial components (not assessed in this study). MMPs seem to be indispensable components for natural cyclic events of ECM remodeling of fish testes and for guarantee tissue homeostasis throughout reproductive cycle.

Feed digestibility and productive performance of bullfrogs raised in cages and fed in different periods and high frequency

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