Estudo clínico randomizado, aberto e comparativo para avaliação de segurança, tolerabilidade e eficácia analgésica de duas diferentes apresentações de medicamento tópico na realização de curetagem dermatológica de molusco contagioso em pacientes pediátricos

Aim: This study aimed to compare the safety and analgesic efficacy of a new topical drug (in two different presentations: cream and aerosol) consisting of benzocaine, menthol and triclosan, in the curettage of molluscum contagiosum. Method: The study included 296 volunteers in different stages: 256 healthy adult volunteers for the safety evaluation, and 40 volunteers between 2 and 12 years old who presented Molluscum contagiosum, for the evaluation of tolerability and efficacy. Each volunteer represented two experimental units (left and right) where it was applied randomly the tested products (cream or aerosol) 30 minutes before the dermatological curettage, immediately after and twice a day during 7 days. Dermatological evaluations of safety and efficacy were performed immediately after the procedure, 3 and 7 days after the curettage. Results: During safety evaluation, the tested products showed no irritant, sensitizing, phototoxic or photosensitizing potential. Both presentations, cream and aerosol, were considered safe with no statistically significant differences between them. With respect to analgesic efficacy, the results showed that the medication promoted the reduction of painful symptoms and there was no statistically significant difference (p <0.05) between the two presentations. Conclusion: The tested product, in two different presentations, was considered safe and effective in controlling pain symptoms during and after the curettage of molluscum contagiosum. © Copyright Moreira Jr. Editora.

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.

Flexibilidade laboral e segurança do trabalhador: uma perspectiva argentina

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Flexibilidade e segurança no mercado de trabalho: a busca da melhoria da proteçao social dos trabalhadores brasileiros

Incluye Bibliografía

Avaliação da segurança e eficácia de novo preenchedor à base de ácido hialurônico no tratamento dos sulcos nasolabiais e contorno dos lábios

Introduction: The use of dermal filling techniques for soft tissue augmentation has greatly increased in recent years. Hyaluronic acid is one of the most used temporary dermal fillers in the treatment of facial wrinkles, furrows, and folds due to its effectiveness and safety. Objective: To evaluate the efficacy and safety of Perfectha®, a new hyaluronic acid filler, for nasolabial folds and lip correction. Methods: Open, multicenter study comprising 87 women. Efficacy was evaluated by the Global Aesthetic Improvement Scale and the Wrinkle Severity Rating Scale. Safety was evaluated through observation and the reporting of side effects. Results: One week after the injection of the filler, improvement in nasolabial folds and lips was observed in 86% and 89% of the women, respectively. Mild or moderate transient inflammatory reaction and ecchymoses occurred in 15% and 9% of patients, respectively, mainly in nasolabial folds. Two patients presented labial herpes simplex after treatment of the lips. The good results were maintained in 76% and 57% of women for nasolabial folds and in 72% and 45% of women for lips after 3 and 6 months, respectively. Conclusion: Perfectha® was effective and safe for these indications.

Uso do AHP na avaliação do desempenho do sistema de gestão da qualidade, meio ambiente e segurança e saúde ocupacional integrados

The paper analyses the application of the AHP method together with the attach A of ISO 9004:2000 in order to evaluate the performance of two industrial organizations, both possessing quality management systems with ISO 9001:2000 certifications, based on the specific requirements of quality, environment, occupational health and management systems. The evaluated organizations were a government-owned company from the science and technology sector that works in the nuclear area, and a private company that works in the automotive and railroad area. The open software Web-Hipre version 1.22 from Helsinki University of Technology, Finland, was used. The results demonstrated that the AHP method together with the attach A of ISO 9004:2000 is adequate to evaluate organizational performances. Both organizations presented similar performance levels.

Estudos de pré-formulação de cápsulas gelatinosas duras contendo formulação de extrato de Gymnema sylvestre em pó

Gymnema sylvestre extract (GSE) is a plant product widely used as an adjuvant in the treatment of diabetes mellitus and commercially available as a powder. Owing to its low flowability, the manufacturing of hard gelatin capsules containing GSE faces specific problems. The purpose of this study was to investigate the best excipient (starch, lactose or microcrystalline cellulose) for hard gelatin capsules containing GSE. The technological properties such us bulk density (ρβ); tapped density (ρt); inter-particle porosity (Ie); Carr index (CI); Hausner ratio (HR); loss on drying (%LOD) and particle size distribution (%Pf) of the various GSE mixtures were investigated with the aim of identifying the best excipient. The need for lubricants (talc/magnesium stearate) was also assessed. GSE was characterized as a fine powder with more than 50% of its particles between 0.149mm to 0.250mm; furthermore, CI=25.6%; RH=1.3 and Ie = 25.6% and, as expected with such properties, it showed poor flowability. All the excipients investigated were able to change the technological properties of GSE and the powder mixture containing microcrystalline cellulose gave the best results.

Estudo da segurança de cosméticos: Presente e futuro

Cosmetics have been used since ancient times and, recently, their consumption has increased greatly in many countries, including brazil, which is the third largest consumer market in the world. Thus, concern for the safety and efficacy of these products should be heightened, even though these products are rarely related to adverse reactions that damage the health. Brazilian law requires manufacturers to subject their products to safety testing, to assess the possible reactions that could be caused by them (irritation, sensitization, systemic effects). To this end, in general, animals have been used as the experimental model, but this practice is being increasingly controlled, so that the scientific community is looking for alternative tests that do not require experimental in vivo models. Thus, this review aims to describe the main biological assays used to assess the safety of cosmetics, as well as in vitro assays that can replace them.

Programação, conexão e avaliação de psicrômetro aspirado de termopar de baixo custo em micrologger para estudos agrometeorológicos

As the psychrometric method is considered standard for the measurement of relative humidity, many studies have used aspirated thermocouple psychrometers connected to microloggers but, however, they do not detail how the aspiration of the air stream is done. However, one of the major difficulties of aspirated thermocouple psychrometers is to program and to connect it in micrologger, because specific programming and connection are requires, and still some skills in getting accurate measurements. This work aimed to provide the programming and the connection of the aspirated thermocouple psychrometer type T for the CR10X microloggers and CR23X of Campbell Scientific, evaluating the quality of measurements of temperature and air relative humidity in relation the a sensor Vaisala HMP50. The non-continuous measurements were made in the period 2006/09/04 to 2007/07/11 at Jaboticabal, SP. The air temperature measurements were similar between the Vaisala sensors and aspirated thermocouple psychrometer, but the relative humidity measurements were significantly different. The measurements obtained by the aspirated thermocouple psychrometer connected to CR10X micrologger were the most accurate. Using the programming and connection of a micro-fan to suck in the dry and moist bulbs of aspirated thermocouple psychrometer in microloggers models CR10X and CR23X, it is possible to obtain measurements of air temperature with good precision and accuracy, and measurements of air relative humidity with good precision, but accuracy is not always attainable due to the difficulties inherent to the physical processes that occur in the wet bulb, the skill in the use and maintenance of this equipment and the reservoir protection against radiative effects.

Resistência da parede abdominal após a remoção cirúrgica dos músculos retos abdominais: estudos experimental em ratos

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Atlas ambiental como subsídio aos estudos de sustentabilidade - a bacia do Araçuaí no Vale do Jequitinhonha - MG

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

Estudos morfológicos e histoquímicos do tubo digestivo de Hemisorubim platyrhynchos (Valenciennes, 1840)

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Estudos limnológicos de balneabilidade no Parque Natural Municipal Cachoeira da Marta (Botucatu, SP, Brasil): relação com possíveis fontes poluidoras

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Busca de princípios para uma atuação a partir de estudos sobre o griots africanos e os jograis medievais europeus

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

Estudos das regiões de baixas velocidades próximas ao lóbulo de Roche de um planeta gigante

Pós-graduação em Física - FEG