Regulação e concorrência no direito portuário : ineficiência regulatória da ANTAQ em relação à THC2

Trabalho de Conclusão de Curso (graduação)—Universidade de Brasília, Faculdade de Direito, 2019.O propósito deste trabalho consiste em entender em que medida a atuação a Agência Nacional de Transportes Aquaviários (ANTAQ) foi ineficiente na regulação da cobrança da Terminal Handling Charge 2 (THC2). O estudo levou em consideração os últimos posicionamentos da agência, a análise concorrencial feita pelo Conselho Administrativo de Defesa Econômica (CADE) sobre a THC2, bem como a coordenação entre a atuação da primeira, enquanto órgão regulador setorial e da segunda, enquanto órgão regulador geral.The goal of the present study is to understand the role of the Brazilian National Agency for Ports and Navigation (ANTAQ) regarding the “Terminal Handling Charge 2” controversy, in order to assess if ANTAQ`s regulation of this matter can be considered legally inefficient. The study considered the last rulings of both ANTAQ and the Administrative Council for Economic Defense (CADE), and the coordination (if any) between these two governmental agencies – as ANTAQ deals with specific regulations of port activities and CADE deals with antitrust matters involving all activities in Brazil

Evaluation of the bioequivalence of two formulations containing the combination of 400 mg of acetaminophen (paracetamol), 4 mg of phenylephrine and 4 mg of chlorpheniramine in capsules: open-label, three-way crossover study, partially replicated in health

This study was carried out in order to compare the relative bioavailability of two different formulations containing 400 mg of acetaminophen + 4 mg of phenylephrine hydrochloride + 4 mg of chlorpheniramine maleate, Test formulation (Cimegripe®) and Reference formulation (Resfenol®) in 84 healthy volunteers of both sexes under fasting conditions. The study was conducted in a single dose, randomized, open-label, crossover 3-way and partially replicated. The tolerability was evaluated by the monitoring of adverse events and vital signs, results of clinical and laboratory tests. Plasma concentrations were quantified by validated bioanalytical methods using the ultra-performance liquid chromatography coupled to tandem mass spectrometry. The Cmax, Tmax, AUC0-t, AUC0-inf, T1/2 and Kel pharmacokinetic parameters were calculated from these obtained concentrations. The 90% confidence intervals were constructed for the ratio reference/test from the geometric average of the Cmax and AUC parameters which were comprised between 80% and 125%. Only the Cmax parameter of the phenylephrine was applied the scaled average bioequivalence due to the intraindividual coefficient of variation > 30% obtained, thus extending the acceptance limits of the interval. It can be concluded that the two formulations were bioequivalent in terms of rate and absorption extent and thus interchangeable

Study of bioequivalence between two formulations containing dipyrone 300 mg + isometheptene mucate 30 mg + caffeine 30 mg: a randomized, open-lable, two period crossover study in healthy adult Brazilian volunteers/ Bioequivalência entre duas formulações contendo 300 mg de dipirona + 30 mg de mucato de isometepteno + cafeína 30 mg: um estudo cruzado randomizado, aberto e de dois períodos, em voluntários brasileiros adultos saudáveis

The combination of dipyrone 300 mg, isometheptene mucate 30 mg and caffeine 30 mg in a single tablet is widely used in Brazil for the acute treatment of various forms of primary headaches. This study aimed to evaluate the bioequivalence between two formulations containing the combination of these active ingredients. An open-label, randomized, single-dose, two-period, two-sequence, two-treatment crossover study was conducted in 80 healthy subjects of both genders. Subjects received a single dose of test coated tablet (Sedamed®, Cimed Indústria de Medicamentos Ltda.) and reference product (Neosaldina®, Nycomed Pharma Ltda.) under fasting conditions according to a randomly assigned order with a 7-day washout period. Serial blood samples were collected up to 24h post-dose. Plasma concentrations of active pharmaceutical ingredients were obtained by a validated liquid chromatography-tandem mass spectrometry method. Pharmacokinetic parameters were calculated using non-compartmental methods. There were no serious adverse events during the study and both formulations were safe and well tolerated during the study. Geometric mean ratios (90% confidence intervals) for Cmax and AUC0-t were 97.04% (94.94 – 99.19) and 98.77% (95.58 – 102.06) for 4-MAA and 100.12% (93.33 – 107.41) and 96.19% (91.24 – 101.42) for isometheptene, respectively. The test formulation of was considered bioequivalent to reference product according to regulatory requirements, and therefore interchangeable

Quantification of dexchlorpheniramine and betamethasone in human plasma by the uplc-ms/ms method and its application in a bioequivalence study containing the two drugs in combination, administered as a single dose in healthy volunteers/ Quantificação de dexclorfeniramina e betametasona em plasma humano pelo método clue-em/em e sua aplicação em um estudo de bioequivalência contendo os dois fármacos em associação, administrados em dose única em voluntários sadios

This study was carried out in order to compare the relative bioavailability of two different formulations containing 2.00 mg of dexchlorpheniramine maleate + 0.25 mg of bethametasona, test formulation (Dexmine®) and reference formulation (Celestamine®) in healthy volunteers of both sexes under fasting conditions. The study was conducted in a single dose, randomized, open-label, crossover 2 x 2. The tolerability was evaluated by the monitoring of adverse events and vital signs, results of clinical and laboratory tests. Plasma concentrations were quantified by validated bioanalytical method employed the ultra-performance liquid chromatography triple quadrupole tandem mass spectrometry, using as the internal standard brompheniramine. Non-compartmental model was applied to determine different pharmacokinetic parameters and these were calculated from the plasma concentrations obtained from the volunteer samples. Bioequivalence between test and reference formulation were demonstrated as the calculated 90 % confidence interval for the corresponding ratios of log transformed pharmacokinetic parameters (Cmax, AUC0-t and AUC0-?) fell within the 80–125 % range, the predetermined criterion for therapeutic equivalence. It can be concluded that the two formulations were bioequivalent in terms of rate and absorption extent and thus interchangeable

Information security management practices: study of the influencing factors in a brazilian air force institution

This article aims at analyzing the factors which influence the staff of the Brazilian Air Force Information Technology Board – DTI in relation to the understanding of the application of the Information Security Management practices. This attempt was based on the hypothetical-deductive method and, as to its objective, it was descriptive in nature. As to the approach of the research problem, it was quantitative in nature. In order to achieve the proposed objective, an adaptation of the Theoretical Technology Acceptance Model – TAM, which allowed the analysis of the relation between sociodemographic profile, perceived ease of use, perceived usefulness, attitude and behavior of the users, and the level of understanding of the Information Security practices. The survey was conducted with 59 military servants and civilians which are part of the Brazilian Air Force Information Technology Board, to whom a questionnaire was applied, submitted and approved by the Committee of Ethics in Research (CAAE: 62636016.7.0000.5111), which was based on the precepts of ISO/IEC 27001 (2013) and 27002, which deal, respectively, with the Information Security Management system and with the code of practice for Information Security controls. Once the data were gathered, they were tabulated and statistically analyzed, which enabled the demonstration of the influence of sociodemographic and behavioral factors and of the precepts of the TAM in the perception of the Information Security practices by the DTI staff

Análise das pesquisas de satisfação dos participantes de estudos clínicos/Analysis of satisfaction surveys of clinical study participants

Objetivo: avaliar o resultado das pesquisas de satisfação aplicadas aos participantes de estudos clínicos. Método: trata-se de um estudo retrospectivo com abordagem quantitativa onde foram utilizados dados secundários, oriundos dos instrumentos aplicados por um centro de pesquisa para avaliar a satisfação dos participantes dos estudos clínicos. Resultados: os participantes dos estudos apresentam-se muito satisfeitos com o atendimento na recepção, com o atendimento médico, com a equipe de enfermagem, com a limpeza dos ambientes e com a estrutura física. Conclusão: notou-se que o nível de satisfação depende da relação cliente-atendimento. Qual seja o tipo de serviço de saúde todos clientes têm expectativas, expressas em necessidades, que devem ser atendidas e, se possível excedidas. É por isso que todos os serviços prestados em saúde devem ter a máxima qualidade e a opinião do cliente deve ser levada à sério, já que é em função dele que a organização existe

IMPLICAÇÕES DO ISOLAMENTO SOCIAL DURANTE A PANDEMIA DO COVID-19 NA COMUNICAÇÃO DE CRIANÇAS

Introduction: With the COVID-19 pandemic, several countries adopted social distancing as a preventive measure, which caused the social isolation of families, consequently, children who were in the course of communication and language development had these processes delayed or not started. Objective: To analyze the impacts of social isolation during the COVID-19 pandemic on children's communication in São Luís - MA. Methods: A retrospective longitudinal observational study was adopted, evaluating the speech-language pathology records, on the communicative behavior, of 15 children treated at a speech-language pathology clinic, considering the last and the first assessment before and after social isolation, respectively. The answers were analyzed in percentage and for statistical analysis, a non- parametric chi-square test was used. Results: It is observed that there were significant differences (P < 0.05) in the results obtained by the evaluations of the medical records regarding the language aspects of the children assisted after social isolation, the children began not to obey orders and auditory and visual commands after isolation. , where an increase of 14% is observed and it differed significantly (P < 0.05) before social isolation. There was a significant change (P < 0.05) in the ratio of children who were sometimes able to communicate by forming sentences of 2 or 3 words correctly in order not to communicate after social isolation, with a   decrease from 36% to 14% of children who were able to communicate and an increase from 14% to 36% in the number of children who cannot. Conclusion: Social isolation during the COVID-19 pandemic negatively influenced the communication of children in São Luís - MA.Introdução: Com a pandemia da COVID-19 vários países adotaram o distanciamento social como medida preventiva, que ocasionou no isolamento social das famílias, consequentemente, as crianças que estavam em curso do desenvolvimento da comunicação e linguagem tiveram esses processos retardados ou não iniciados. Objetivo: analisar os impactos do isolamento social durante a pandemia da COVID-19 na comunicação de crianças em São Luís - MA. Métodos: Adotou-se estudo observacional do tipo longitudinal de caráter retrospectivo avaliando prontuários fonoaudiológicos, sobre o comportamento comunicativo, de 15 crianças atendidas numa clínica fonoaudiológica, considerando-se a última e a primeira avaliação antes e após o isolamento social, respectivamente. As respostas foram analisadas em porcentagem e para análise estatística adotou-se teste não paramétrico quadrado. Resultados: Observa-se que houve diferenças significativa (P < 0,05) nos resultados obtidos pelas avaliações dos prontuários quanto aos aspectos de linguagem das crianças atendidas depois do isolamento social, as crianças passaram a não obedecer a ordens e comandos auditivos e visuais depois do isolamento, onde se observa aumento de 14% e diferiu significativamente (P < 0,05) antes do isolamento social. Ocorreu mudança significativa (P < 0,05) na relação das crianças que conseguiam às vezes se comunicar formando frases de 2 ou 3 palavras corretamente para não se comunicar depois do isolamento social, com diminuição de 36% para 14% das crianças que conseguiam às vezes se comunicar e aumento de 14% para 36% no quantitativo de crianças que não conseguem. Conclusão: O isolamento social durante a pandemia do COVID-19 influenciou negativamente na comunicação de crianças em São Luís – MA

Uso das novas tecnologias para a produção textual do gênero fotopoema em inglês

Este estudo apresenta e discute resultados da aplicação de um produto educacional, elaborado em um Programa de Pós-Graduação em Ensino de Ciências Humanas, Sociais e da Natureza, no que se refere à produção textual em Inglês, a partir do gênero fotopoema, com o uso da rede social Facebook. A investigação caracteriza-se, basicamente, como pesquisa de campo, descritiva, bibliográfica e analítica. Como resultados, foi possível desenvolver em uma turma de alunos do 1º ano do Ensino Médio a habilidade de Writing por meio do gênero fotopoema e divulgar os trabalhos em uma página da rede social Facebook e os alunos se sentiram mais motivados a realizar atividades de Writing na aula de Língua Inglesa