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Abstract The Department of Acute Kidney Injury (IRA) of the Brazilian Society of Nephrology prepared this document for the purpose of standardizing AKI terminology and dialysis modalities in the Portuguese language for Brazil. Several terms with similar meanings have been used in AKI and its dialysis modalities, causing confusion and disparities among patients, nephrologists, health institutions, private care companies, insurance companies and government entities. These disparities can impact medical care, hospital organization and care, as well as the funding and reimbursement of AKI-related procedures. Thus, consensual nomenclature and definitions were developed, including the definitions of AKI, acute kidney disease (AKD) and chronic kidney disease (CKD). Additionally, we addressed all dialysis modalities and extracorporeal procedures related to AKI, currently approved and available in the country. The Brazilian Society of Nephrology hopes that this Consensus can standardize the terminology and provide technical support to all involved in AKI care in Brazil.
Resumo O Departamento de Injúria Renal Aguda (IRA) da Sociedade Brasileira de Nefrologia elaborou o presente documento para fins de padronização da terminologia em IRA e modalidades dialíticas na língua portuguesa para o Brasil. Diversos termos com significados semelhantes têm sido empregados em IRA e suas modalidades dialíticas, causando confusão e disparidades entre pacientes, nefrologistas, instituições de saúde, empresas privadas de assistência, seguradoras e entidades governamentais. Essas disparidades podem impactar a assistência médica, a organização e o atendimento hospitalares, assim como o financiamento e reembolso dos procedimentos relacionados com a IRA. Assim, nomenclatura e definições consensuais foram elaboradas, incluindo-se as definições de IRA, doença renal aguda (DRA) e doença renal crônica (DRC). Adicionalmente, todas as modalidades dialíticas e os procedimentos extracorpóreos relacionados a IRA, atualmente aprovados e disponíveis no país, foram abordados. A Sociedade Brasileira de Nefrologia espera que este Consenso possa padronizar a nomenclatura e prover suporte técnico para todos os atores envolvidos na assistência à IRA no Brasil.
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Background: The World Health Organization (WHO) recommended that the toxicity data of a traditional medicine (TM) product that has been in use for 20 years or more without untoward effects should be determined, as the first step in its research and development (R&D). Such data in conjunction with efficacy data would be used to develop an appropriate dosage form of the product. A key objective in researching such a product is to validate the basis of the therapy, including the formula. Such validation, and any attempt to modernize the product, should be guided by an understanding of the traditional know-how. The Nigerian National Institute for Pharmaceutical Research and Development (NIPRD) utilized this approach in developing Niprisan, an antisickling drug, based on a TM product used since antiquity in Yoruba Medicine. Aim: This article aimed to advocate the continuance and improvement of the WHO model of herbal drug research and regulation (HDRR) as the most logical approach for adoption by researchers and regulators. Methodology: NIPRD’s adoption of the WHO model since 1989 was reviewed in parallel with trends in herbal drug research worldwide; and within the contexts of regulatory practices by Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) and the European Medicines Evaluation Agency (EMEA), with a view to identifying more effective strategies within the WHO paradigm for HDRR. Conclusion: Drug regulatory agencies (DRAs) like NAFDAC require effective laws, policies and quality management systems (QMS) to execute their mandates effectively. On the other hand, NIPRD’s output depends upon proper actions by a seasoned and responsive DRA. Therefore, noting that NIPRD and NAFDAC were both created by military decrees in 1989 and 1992 respectively, rather than by parliament acts, it is recommended that in addition to instituting more effective laws and policies to regulate NAFDAC, both NIPRD and NAFDAC need to adopt and implement suitable QMS for self-regulation, eg: ISO 9001 for whole organizations; and ISO/IEC 17250 for the laboratories.
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Introducción: El entorno regulatorio mundial es cada vez más exigente para establecer, implementar y mantener el cumplimiento de las buenas prácticas clínicas (BPC). En Cuba, una respuesta necesaria derivada del desarrollo creciente de la industria farmacéutica y biotecnológica nacional fue la creación del Centro Nacional Coordinador de Ensayos Clínicos (CENCEC). Una de las misiones del CENCEC es preparar a las unidades-sitios clínicos seleccionados que realizan investigaciones clínicas, para su posterior certificación en BPC por la autoridad reguladora nacional, con la finalidad de avalar la calidad que corresponde al proceso de investigación clínica que redunda en una esmerada atención y protección al paciente objeto de estudio. Objetivo: Describir la estrategia del CENCEC para la preparación en BPC de los sitios clínicos seleccionados del Sistema Nacional de Salud (SNS) que participan en ensayos clínicos. Métodos: Se revisan más de 250 documentos normativos emitidos por Europa, Estados Unidos, Japón y los países nórdicos relacionados con aspectos prácticos y éticos para la implementación de las BPC...
Background: The global regulatory environment is increasingly demanding to establish, implement, and maintain the compliance with Good Clinical Practices (GCP). In Cuba, The National Coordinating Center for Clinical Trials (CENCEC) was created as a necessary response derived from the increasing development of the national pharmaceutical and biotechnological industry. One of the missions of the CENCEC is to prepare selected clinical units/sites that conduct clinical research for a further certification in GCP by the national regulatory authority in order to guarantee the quality that corresponds to the process of clinical research, resulting in a careful attention and protection of the patient under study. Objective: To describe the strategy of the CENCEC for the preparation of good clinical practices in the selected clinical sites of the National Health System (SNS) that participate in clinical trials. Methods: More than 250 regulatory documents issued by Europe, the United States, Japan and the Nordic countries, related to ethical and practical aspects for the implementation of good clinical practices, were reviewed...
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Clinical Trials as Topic/methods , Practice Guidelines as Topic/standards , Health Facilities/standards , Evidence-Based Practice/methods , Enacted StatutesABSTRACT
Tendo em vista que crianças com necessidades educacionais especiais necessitam atenção diferenciada quanto aos métodos utilizados nas instituições de ensino, o objetivo do presente trabalho foi capacitar professores em intervenção comportamental, contribuindo assim para o processo de inclusão. Essa capacitação consistiu em ensinar princípios da análise do comportamento, análise funcional e o procedimento de reforço diferencial de comportamentos alternativos (DRA), por meio de um programa informatizado de ensino. Participaram do processo quatro professoras de uma escola municipal. Com os dados obtidos, observou-se que as professoras aprenderam, de modo geral, princípios da análise do comportamento, análise funcional e DRA, colocando-se propensas à utilização dos procedimentos em sala de aula.
It is recognized that, during schooling, children with special educational needs require additional attention from educational institutions relative to the education methods. The proposal of this study was to capacitate teachers in behavioral techniques in order to contribute to the inclusion process of children with special needs. This training consisted in teaching behaviour analysis principles, functional analysis and the procedure of differential reinforcement of alternative behaviors (DRA) utilizing an educational software. Four teachers from municipal schools were submitted to this training. Our data demonstrate that trained teachers, in general, learned the behavior analysis principles, functional analysis and DRA suggesting that they will be able to use these procedures in classroom.
Dado que los niños con necesidades educativas especiales requieren atención especial con relación a los métodos utilizados en las instituciones educativas, el objetivo de este estudio fue el de capacitar a los docentes en el manejo de comportamiento, contribuyendo así al proceso de inclusión. Esta formación tubo como objetivo enseñar los principios de análisis de comportamiento, análisis funcional y el procedimiento de refuerzo diferencial de conductas alternativas (DRA) por medio de um programa computarizado. Cuatro maestros participaron del proceso en una escuela municipal. Con los datos obtenidos, se observó que los maestros aprendieron, en general, los principios de análisis de comportamiento, análisis funcional y DRA, y están dispuestos a utilizar los procedimientos en el aula.
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Humans , Child , Education, Special , Mainstreaming, Education , Professional TrainingABSTRACT
In this paper the application of DNA fingerprints to evaluate the efficiency of DNA extraction was studied DNA mixtures of landfill leachate and active sludg e were extracted using three different methods and the DNA extraction was evalua ted by ARDRA and RISA fingerprints The results showed that RISA is a effecti ve way to evaluate DNA extraction