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.

Estabilidade, polimorfismo, dissolução e correlação in vivo-in vitro de Darunavir comprimidos

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

Phytotherapy: an introduction to its history, use and application

There has been a great advance in the pharmacognosy field, which has increased the use of medicinal plants by health professionals and practitioners of folk medicine. This systematic review explored the history and the present day application of phytotherapeutic medicines. We searched the databases Cochrane Library, Embase, Lilacs, PubMed, Scielo and a specialized bibliography. We concluded that there are many therapeutic potentialities in the use of phytotherapeutic medicines and medicinal plants. We also concluded that despite the increasing number of publications in the field each year, there is still a lack of reviews and meta-analyses that could promote a better integration of the knowledge produced. In addition, research about pharmacological interactions and multidisciplinary studies may promote a quicker and safer process from the workbench up to the clinical trials.

Desempenho e aspectos sanitarios de bezerras leiteiras que receberam dieta com ou sem medicamentos homeopaticos

O objetivo deste trabalho foi avaliar, do nascimento até os 120 dias de idade, o desenvolvimento corporal, o consumo de matéria seca (CMS), a conversão alimentar (CA) e os aspectos sanitários de 12 bezerras leiteiras que receberam dieta com ou sem o uso de medicamentos homeopáticos. Foram utilizadas bezerras 3/4 Holandês x 1/4 Gir recém-nascidas, com peso vivo médio inicial de 35,71 kg, distribuídas pelos tratamentos em delineamento inteiramente casualizado, com seis repetições por tratamento. Na fase de aleitamento (0 - 56 dias de idade) os tratamentos consistiram em leite, sendo 2 litros pela manhã e 2 à tarde, adicionado ou não a medicamentos homeopáticos (5 g/animal/dia dos FATORES PRÓ(r), ESTRESSE(r) e C&MC(r)), e concentrado à vontade. Na fase pós-aleitamento (57 - 120 dias de idade), os animais receberam o mesmo concentrado, adicionado ou não com os mesmos medicamentos homeopáticos, e o consumo do concentrado foi limitado a, no máximo, 3 kg/animal/dia. A adição de medicamentos homeopáticos à dieta não afetou (p > 0,05) o desenvolvimento corporal, o CMS e o CA em bezerras leiteiras. Houve menor uso de antibiótico e carrapaticida nos animais que receberam os produtos homeopáticos. Concluiu-se que o uso de medicamentos homeopáticos não afetou o desenvolvimento corporal e reduziu o número de animais tratados com medicamentos alopáticos.

Potencial de óleos essenciais de plantas para o tratamento de enfermidade em peixes

Pós-graduação em Aquicultura - FCAV

Uma análise dos efeitos do uso a longo prazo de antidepressivos

Pós-graduação em Psicologia - FCLAS

Caracterização de poliformos em comprimidos distribuídos pela Secretaria de Saúde de Araraquara por difração de raios X

Pós-graduação em Química - IQ

Estudo químico e avaliação da atividade biológica de Eugenia brasiliensis e Eugenia involucrata (Myrtaceae)

Pós-graduação em Química - IQ

Embalagens de medicamentos: diretrizes para o desenvolvimento

Pós-graduação em Design - FAAC

ANTIDIARRHEAL MECHANISM AND IONIC PROFILE OF CARPOLOBIA LUTEA ETHANOLIC STEM-BARK EXTRACT IN RATS

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

Validation of analytical methodology for quantification of cefazolin sodium pharmaceutical dosage form by high performance liquid chromatography to be applied for quality control in pharmaceutical industry

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

Depression and Cognitive Decline: Factors Related to Demographics and Psycho Pharmacotherapy on Elderly in Nursing Homes

Objectives: To identify the prevalence of neuropsychiatric disorders, especially DP and CD, on a sample of nursing home residents, relating this prevalence with some aspects of the demographics and psycho pharmacotherapy. Methods: 48 elders from two different nursing homes were selected. The collection of demographic and pharmacological data was made utilizing medical records. The medication was classified according to the Anatomical Therapeutic Chemical Code (ATC) criteria. The Geriatric Depression Scale (GDS 30) and the Mini Mental State Examination (MMSE) tests were utilized to determine the prevalence of DP and CD. Results: It was observed in the sample a high incidence of DP and CD among the researched elders. More schooling individuals tend to present less CD. Individuals with less CD indicatives present less symptomatology for DP. Of all the researched elders, 54,2% are submitted to psycho pharmacotherapy. Of all the consumed medicine, 16,5% belonged to the class of neuropsychiatric medicine. The medicated elders present, in average, a larger symptomatology for DP (12 points/average/GDS) than the non-medicated elders (9,9 points/average/GDS). The inverse occurs in relation to the CD indicatives. The use of psychotropics, especially in association, can have negative effects related to depression and cognition. Discussion: The pharmacotherapy, characterized for the polymedication and chronicity, especially of neuropsychiatric medicines, deserves special attention among elders, because the data suggest a significant relation between the utilization of medicines, singly or in association, and the increase of CD and DP. In addition, the data suggest that DP is a risk factor for CD and DM.

Análise da atividade antimicrobiana dos extratos de Cordia verbenacea DC, Mikania laevigata Sch. Bip. ex Baker e Psidium Cattleianum frente a microrganismos endodônticos

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

O discurso do uso de animais nas pesquisas de Educação Física

It is possible in many countries, perhaps all, there is business groups of pharmaceuticals industry, cosmetics together with the universities that use animals in scientific research and testing for the creation of new products and medicines. Currently is growing discussion about standards and criteria for the use of these animals (guinea pigs) and also increases the number of debates on ethical issues in research with animal models. This research seeks to portray the reality of the use of animals in scientific research academic at the University, specifically to research in physical education, as it has used animals in the areas of Physiology of Sport and Physical Activity, Nutrition for Athletes, among others. Initially is shown the pre-reflection, exposing the laws governing the subject, treating the animal experimentation with regard to its history and the issues of speciesism and the methodological mistake. It reveals what it is and as is the use of animals in education and the inability of the student to change that reality, to refuse to participate in the cruel activity, and even they are aware of their rights as in the case of the withdrawal of consciousness. Presents researchers and universities not use animals and ends the pre-debate showing Who is really the most animal research at the university by providing alternatives for them. We conducted a literature survey on animal experimentation, research universities, and alternative methods. The following is the phenomenon in understanding and awareness of the researchers who use animals in their research, conducting a phenomenological analysis of his speeches, revealing the meanings of their animal research. The focus of this study is, therefore, the analysis of discourses of researchers who carried out research using animal experiments (guinea pigs). The phenomenon of understanding of the researchers about their research is made clear... (Complete abstract click ectronic access below)

Atividade antimicrobiana de plantas medicinais e aromáticas pertencentes à CPMA - Coleção de Plantas Medicinais e Aromáticas do CPQBA - UNICAMP

The increase of the antimicrobial resistance and its propagation around the world are the biggest threats to the public health care and to the treatment of diseases caused by microorganisms. Nowadays the antimicrobial resistance has increased abruptly. The essential oils are volatile and aromatic compounds derived from parts of plants as flowers, leafs, fruits, seeds, roots, sprouts, among others. The activity of extracts and essential oils of several plant species have been recognized and studied by empirical methods since a long time, but its antimicrobial activities were confirmed recently. Medicinal plants are used in folk medicine as medicines, antibiotic, analgesic, sedative and anti-inflammatory. The use of medicinal plants like source of medicines is an alternative of therapeutics for diseases treatment. In Brazil, studies with this goal are very important, once medicinal plants have been used as a choice of treatment and prevention of infections and diseases in health areas. Considering the fact that some products from medicinal plants have antimicrobial properties it is expected that using screening programs, new potential medicaments could be developed. Otherwise, scientific researches focused on determining therapeutic potential of plants are limited, there are lack of scientific studies which confirms the potential antibiotics properties of a large number of plants. The aim of the present study is determinate the antimicrobial activity of 10 medicinal species belonging to CPMA - Collection of Medicinal and Aromatic Plants from CPQBA/UNICAMP. The minimal inhibitory (MIC) and minimal bactericidal or fungicidal concentration (MBC) will be determined against the bacteria Escherichia coli, Pseudomonas aeruginosa, Salmonella choleraesuis, Staphylococcus aureus and the yeast Candida albicans. Furthermore, will be conducted chemical identification and fractionation of essential oils and extract with better activity