999 resultados para Regulação Sanitária de Medicamentos
Resumo:
Neste trabalho são apresentados os achados observados na tomografia computadorizada de alta resolução de um paciente com talcose pulmonar, com a doença adquirida pelo uso de drogas orais injetadas por via venosa. O principal aspecto observado na tomografia computadorizada de alta resolução foi o de nódulos centrolobulares, associados a massas conglomeradas. Havia também enfisema e áreas de atenuação em vidro fosco. Estes achados são bastante sugestivos de talcose pulmonar.
Resumo:
OBJETIVO: Avaliar o impacto das ações de vigilância sanitária sobre a qualidade das imagens mamográficas no Estado da Paraíba. MATERIAIS E MÉTODOS: Em 17 serviços de mamografia do Estado foi exigida pela Vigilância Sanitária a aplicação de testes de qualidade de acordo com a Portaria 453/98 do Ministério da Saúde. Foram utilizados simuladores específicos de mama para a avaliação da qualidade. Uma pontuação foi utilizada para classificar a qualidade de imagem de cada serviço. Considerou-se como critério mínimo e imprescindível o atendimento de uma pontuação 70% dos itens de qualidade. Entre os anos de 1999 e 2003 foi analisada a pontuação de qualidade de imagens desses serviços. Foi realizado um programa de educação de controle de qualidade de imagem pela Vigilância Sanitária da Paraíba. RESULTADOS: Os percentuais de serviços de mamografia que atingiram critério imprescindível de qualidade foram: 1999 (25%), 2000 (77%), 2001 (82%) e 2003 (81%). CONCLUSÃO: Os resultados obtidos demonstram haver uma significativa evolução na qualidade das imagens diagnósticas produzidas pelos serviços de mamografia após a implantação de programas de controle de qualidade da imagem.
Resumo:
Objetivo: Conocer la opinión de los estudiantes sobre un seminario que enseña la interacción de los médicos con las fuentes comerciales de información de los medicamentos. Sujetos y métodos: Se realizó una encuesta a los estudiantes de tercero de medicina sobre un seminario que trataba de las fuentes comerciales de información de medicamentos. El seminario incluyó una videograbación de un representante comercial de una empresa farmacéutica que presentaba un nuevo medicamento a un médico, y ejemplos de información sobre medicamentos incluida en el catálogo comercial Vademécum Internacional y en los anuncios publicitarios. Se preguntó a los estudiantes el grado de interés y de satisfacción con el seminario y qué nivel de utilidad creían que podían tener las actividades desarrolladas en el seminario en su futuro profesional. En la valoración de la opinión se utilizó una escala de Likert (de 0 a 10 puntos). Resultados: De 107 estudiantes que asistieron a los seminarios, 101 (94%) participaron en la encuesta. La edad media de los estudiantes fue de 21 años (desviación estándar-DE-: 2,2 años) y 75 fueron mujeres (74%). La puntuación media del grado de interés fue de 7,4 (DE: 1,5), del grado de satisfacción de 7,5 (DE: 1,6) y del grado de potencial utilidad de 7,6 (1,6). Conclusión: Los estudiantes de medicina están interesados en las actividades docentes sobre las fuentes de información comercial, y consideran que pueden ser potencialmente útiles para su futuro profesional. Es necesario formar y preparar a los estudiantes de medicina para la interacción con las fuentes comerciales de medicamentos.
Resumo:
Photodynamic Therapy (PDT) is a clinical procedure, which utilize a photosensitive compound and light. This is a new modality of treatment for cancer, aged related macular degenerescence (AMD), psoriasis, arthritis, arterial restenosis, etc which exhibits efficiency, less traumatic effects, low recovery time and few co-lateral effects. The first officially approved drug for PDT by the Food and Drug Administration (EUA) is Photofrinâ, which is applied for cancer. A new generation drug for PDT, Visudyneâ was recently approved to treat AMD; its photoactive compound is BPDMA, a benzoporphyrin mono-acid derivative (chlorin-type molecule). A concise history, technical information and some drugs for PDT are reported.
Resumo:
Different agencies that supply validation guidelines worldwide establish almost the same parameters to be evaluated in the validation process of bioanalytical methods. However, they recommend different procedures, as well as establish different acceptance criteria. The present review delineates and discusses the stages involved in the validation procedures of bioanalytical methods designed for determining veterinary residues in food, explaining the main differences in the guidelines established for this purpose by the main regulatory agencies in the world.
Resumo:
Una de las prácticas de laboratorio de Tecnología Farmacéutica requiere la elaboración de comprimidos en la asignatura de Farmacia Galénica II siguiendo el mismo flujo de fabricación al empleado en la industria farmacéutica (pesada, tamización, mezclado, amasado, granulación, secado, mezclado y compresión). Estos comprimidos se analizan en la asignatura de Farmacia Galénica III (entre 6 y 12 meses más tarde) por los mismos alumnos según las directrices de la Real Farmacopea Española.En el trabajo se exponen gráficamente los resultados hallados y se comentan los principales puntos de mejora ya que el producto elaborado no es conforme en la mayoría de los casos (sólo alrededor del 50% de los productos elaborados por los alumnos podrían ser conformes, aún siendo un proceso validado). Realmente, la experiencia de los operadores es el punto más crítico que influye en los resultados de estos lotes de comprimidos, sobre todo en el laboratorio analítico. Esta hipótesis ha sido confirmada en lotes analizados por el personal cualificado del departamento de control de calidad del Servei de Desenvolupament del Medicament de la Facultat de Farmàcia de la Universitat de Barcelona, ya que en todos los casos los resultados obtenidos fueron más exactos, repetitivos y cercanos a los teóricos.
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The importance of natural products as a source of new high value-added drugs has, no doubt, transformed Brazilian megadiversity into one of the country's most valuable and strategic assets. Thus the rational exploration of the Brazilian flora on an economic basis should be considered as part of a national development strategy. In this respect, governmental mechanisms to stimulate regulation on the access, bioprospection and industrial use of natural products represent a crucial issue. The aim of this paper is to show how the incentives and institutional arrangements that led to one of the greatest breakthroughs in the pharmaceutical industry, the development and commercialization of the anti-cancer agent Taxol, could be applied to the Brazilian case.
Resumo:
Regulatory pressure is increasingly focusing on the use and disposal of substances hazardous to human health and environment. In the last years efforts have also been made to introduce green chemistry concepts in undergraduate courses. In this paper we present an experiment on the oxidation reaction of borneol to camphor with bleach in acetone. This experiment is important to show undergraduate students that a cheap and non hazardous commercial product can be a useful oxidation agent of alcohols.
Resumo:
This paper proposes a methodology for spectrophotometric determination of hexamethylenetetramine (HMT) by using chromotropic acid in a phosphoric acid media employing a domestic microwave oven as a source of heating. The reddish-purple soluble product is quantitatively formed after 30 s of irradiation and obeys the Beer´s law in the range between 0.1-1.2 mg L-1 HMT (r = 0.99925). The method was applied successfully in commercial pharmaceutical preparations containing dyes in their composition. The results showed that the method proposed is feasible for simplicity, speed, low cost, precision and accuracy when compared with United States Pharmacopeia official method.
Resumo:
In this work the evaluation of the dissolution profile of captopril-hydrochlorothiazide and zidovudine-lamivudine associations were carried out by multivariate spectroscopic method. The models were developed by partial least square regression from 20 synthetic mixtures using mean-centered spectral data. The external validation was accomplished with 5 synthetic mixtures shown mean prevision error of about 1%. Good agreement was observed in the analyses of commercial drugs (content uniformity and dissolution profile), considering the results obtained by the standard chromatographic method, with prevision error lower than 10%.
Resumo:
Two methods for the determination of Ivermectin in veterinarian medications were developed and compared. One of the methods was based on UV spectrometry and the other on HPLC-UV. The former method was shown to be positively biased regarding the nominal concentrations of Ivermectin in different medications. The method of standard addition was unable to correct this bias, indicating significant matrix effects. The HPLC-UV method showed good linearity, throughput, recovery and limits of detection and quantitation adequate for its application in the evaluation of Ivermectin in medications. Several medications were evaluated and good agreement between our results and their nominal concentrations was found.
Resumo:
History shows that public health actions to combat epidemics are most effective when there is constant synergy of both government and society, exemplified by prevention actions in the fight against dengue fever, H1N1 influenza etc. Private-public-partnerships (PPP) can also provide more dynamic and consistent results in production through interaction among Government, University and Enterprise actors. This article puts forward proposals to tackle the problem of neglected tropical diseases via the formation of a Management Council using Etzkowitz's Triple Helix concept to attenuate this public health issue in Brazil.
Resumo:
This paper reports the evaluation of extraction strategies for the treatment of medicine samples to determine chromium and nickel by GFAAS. Different approaches for extraction were evaluated and the most efficient involved magnetic stirring. The metals were quantitatively extracted by stirring 0.20 g samples with 25 mL of 2.0 mol L-1 HCl solution for 60 min. The developed method was successfully applied for the determination of Cr and Ni in tablets containing antibiotics and raw materials, with cephalexin and ciprofloxacin as active ingredients.