Issues about the rationality of subject selection in chemical generic drug registration application:a discussion / 国际药学研究杂志

Some issues about the rationality of subject selection are identified in the registration applications of chemical generic drugs. It should be the sponsor's responsibility to follow the latest information about safety, efficacy and quality control of the proposed drug, and provide a sound basis for subject selection. In this article, issues about the basis of the subject selection of chemical generic drugs are discussed from the aspects of compound, formulation and strength.

Issues about the rationality of subject selection in chemical generic drug registration application:a discussion / 国际药学研究杂志

Some issues about the rationality of subject selection are identified in the registration applications of chemical generic drugs. It should be the sponsor's responsibility to follow the latest information about safety, efficacy and quality control of the proposed drug, and provide a sound basis for subject selection. In this article, issues about the basis of the subject selection of chemical generic drugs are discussed from the aspects of compound, formulation and strength.

Descrição metodológica da seleção de participantes em uma intervenção para a promoção da atividade física pela Estratégia de Saúde da Família / Methodological description of the selection of participants in an intervention to promote physical activity by the Family Health Strategy

Uma das formas de estimular a atividade física da população é por meio de intervenções no Sistema Único de Saúde (SUS). São escassos os estudos de avaliação de promoção da atividade física aplicáveis na Estratégia de Saúde da Família (ESF) e uma das dificuldades desses estudos se referem à seleção dos participantes. O objetivo deste estudo foi descrever o processo de seleção da amostra de uma intervenção para promover a atividade física no SUS/ESF. Utilizando dados pertencentes à ESF de três unidades básicas de saúde (Pedro de Souza Campos, Jardim Keralux e Vila Císper), foram selecionados sujeitos inativos no lazer, insuficientemente ativos no deslocamento e sem apresentar doenças crônicas não transmissíveis. Após quatro meses de coleta foram abordados 966 sujeitos, sendo excluídos 541 sujeitos (29,8% por possuir alguma DCNT, 21,8% por serem fisicamente ativos no deslocamento e 30,3% por realizar alguma atividade física no lazer), ocorreram 147 recusas (15,2%), 25 ausências (2,6%), 243 foram elegíveis (26,2%) e 157 sujeitos iniciaram o estudo (16,3%). Entre os incluídos no estudo, ocorreram diferenças na seleção por gênero (108 mulheres x 49 homens) e, dentre os excluídos, os homens apresentaram maiores proporções de praticantes de atividade física moderada (p<0,001) e vigorosa (p=0,009) no lazer. 45% dos sujeitos foram abordados em dias e períodos sem o atendimento das UBS. O processo de amostragem, considerando as informações existentes em cada unidade básica de saúde, mostrou-se eficaz, pois garantiu a semelhança entre os grupos respeitando a organização da ESF.

The interventions in the Unified Health System (SUS) are a way to encourage physical activity of the population. There are few studies evaluating physical activity promotion applicable on the Family Health Strategy (ESF) and one of the difficulties of these studies refers to the selection of participants. The objective of this study was to describe the process of sample selection of an intervention to promote physical activity in SUS / ESF. Using data pertaining to the FHS three basic health units (Pedro de Souza Campos, Jardim Keralux and Vila Císper), inactive subjects were selected during leisure time, insufficiently active in transportation and without presenting chronic diseases. After four months of collection 966 subjects were approached, 541 subjects were excluded (29.8% for having a chronic diseases, 21.8% for being physically active in transportation and 30.3% by performing some physical activity during leisure time), there were 147 refusals (15.2%), 25 absences (2.6%), 243 were eligible (26.2%) and 157 subjects started the study (16.3%). Among those included in the study, there were differences in the selection of gender (108 women vs. 49 men), with men showing higher proportion of practitioners of moderate physical activity (p< 0.001) and vigorous (p = 0.009) during leisure time, and 45% of subjects were discussed days and periods without the assistance of UBS. The sampling process, considering the information in each primary care unit, proved effective because it ensured the similarity between the groups respecting the organization of the ESF.