Quality by design approaches for pharmaceutical development and manufacturing of Chinese medicine / 中国中药杂志

The pharmaceutical quality was built by design, formed in the manufacturing process and improved during the product's lifecycle. Based on the comprehensive literature review of pharmaceutical quality by design (QbD), the essential ideas and implementation strategies of pharmaceutical QbD were interpreted. Considering the complex nature of Chinese medicine, the "4H" model was innovated and proposed for implementing QbD in pharmaceutical development and industrial manufacture of Chinese medicine product. "4H" corresponds to the acronym of holistic design, holistic information analysis, holistic quality control, and holistic process optimization, which is consistent with the holistic concept of Chinese medicine theory. The holistic design aims at constructing both the quality problem space from the patient requirement and the quality solution space from multidisciplinary knowledge. Holistic information analysis emphasizes understanding the quality pattern of Chinese medicine by integrating and mining multisource data and information at a relatively high level. The batch-to-batch quality consistence and manufacturing system reliability can be realized by comprehensive application of inspective quality control, statistical quality control, predictive quality control and intelligent quality control strategies. Holistic process optimization is to improve the product quality and process capability during the product lifecycle management. The implementation of QbD is useful to eliminate the ecosystem contradictions lying in the pharmaceutical development and manufacturing process of Chinese medicine product, and helps guarantee the cost effectiveness.

Unnecessity of Integrating Metabolic Indices into the Diagnosis of Polycystic Ovary Syndrome / 昆明医科大学学报

Objective To discuss whether it is necessary to integrate metabolic indices into diagnosis of polycystic ovary syndrome (PCOS).Methods Taking ESHRE/ASRM diagnosis as the gold standard,51 women with PCOS and 47 women without PCOS were selected and divided into the intervention group and control group respectively from the Department of Gynecology in the Second Affiliated Hospital of Kunming Medical University between January 2013 and July 2014.Logistic regression based on principal component analysis and significant variables chosen through single factor analysis were used to establish the new diagnostic model which combined reproductive indices and metabolic indices.We evaluated the validity and reliability of the new diagnostic model by using ROC curve analysis.Finally,we analyzed the consistence and difference between the new diagnostic model and the gold standard.Results Thirteen significant variables were chosen using single factor analysis.ROC analysis showed that an area under the curve was 0.976 (P＜0.001) and the optimal cut-off point was 0.526 with a sensitivity of 96.08％,a specificity of 93.62％ and a consistency of93.88％.The new diagnostic model had superior validity and reliability.The two diagnostic methods had strong consistence (Kappa=0.877,P＜0.001) and no difference (x2=0.167,P=0.688).Conclusion Considering that the integration of metabolic indices does not change the diagnosis result,we come to a conclusion that it is unnecessary to integrate metabolic indices into diagnosis of PCOS.

Modelagem estrutural fatorial e consistência Interna da escala de autoestima de Rosenberg em adolescentes brasileiros / Factorial structure modeling and internal consistence in the Rosenberg self-esteem scale in Brazilian teenagers

A autoestima é o processo avaliativo do autoconceito e deve ser mensurada com instrumentos fdedignos e confáveis. Adicionalmente, a avaliação dessa característica vem sendo considerada uma ferramenta importante na identifcação e na prevenção de problemas psicológicos. Foi objetivo de este trabalho realizar de forma mais robusta, a partir da análise de modelo de equação estrutural efetuada no Amos a avaliação fatorial da escala de autoestima, elaborada por Rosenberg em diferentes amostras etárias de 12 a 20 anos. A amostra foi composta por 1864 sujeitos, onde 49% destes eram do sexo masculino e 51% feminino. De acordo com os resultados obtidos, a escala de autoestima apresentou indicadores estatísticos que justifcam a sua consistência fatorial para amostra de jovens brasileiros, confrmando os dois fatores propostos: autoestima negativa e autoestima positiva. Considerando os indicadores estatísticos do modelo fatorial, estes, revelaram-se satisfatórios dentro dos intervalos que têm sido considerados como aceitáveis na literatura vigente.(AU)

The self-esteem is the evaluation process of self-concept and must be measured with real and reliable tools. Additionally, the evaluation of that characteristic has been considered an important implement in identifcation and in prevention of psychological problems. It was objective of this work to perform in more robust way, through Confrmatory Factor Analysis and an analysis of Structural Equation Modeling made based in Amos Graphics, the factorial structure of the scale of self-esteem, created by Rosenberg in different age line samples from 12 to 20 years. The sample was composed by 1864 subjects, where 49% of these were males and 51% were females. According results obtained in these analyses, the scale of Rosenberg presented statistical indicators that justify its factorial consistence for Brazilians teenagers These indicators corroborate suitability of structure of scale of self-esteem for the sample context analyzed composed by two factors: negative self-esteem and positive self-esteem. Considering the indicators they have proved satisfactoryinthe intervalswhich have beenconsideredacceptablein thecurrent literature.(AU)

Efeito da aprendizagem no desempenho de repetidos testes de Wingate / Learning effect in the performance in Wingate repeated tests / Efecto del aprendizaje nel desempeño de repetidas evaluaciones de Wingate

O objetivo do estudo foi verificar a existência do efeito aprendizagem nos resultados de repetidos testes de Wingate. Doze ciclistas foram submetidos a dois testes de Wingate (TW1 e TW2) com intervalo de uma semana. A resistência adicionada foi equivalente a 10% da massa corporal e as rotinas foram planejadas para reproduzir as mesmas condições em ambos os testes. Os resultados revelaram grande amplitude nos limites de concordância dos testes 1 e 2 em todas as variáveis, bem como diferenças significantes para Potência Média (PM), em valores absolutos (TW1: 579,7 ± 91,0 W vs TW2: 616,9 ± 102,2 W) e valores relativos (TW1: 8,3 ± 0,8 W/kg vs TW2: 8,8 ± 0,9 W/kg). A evidência demonstra a existência do efeito aprendizagem causando influência nos resultados da potência anaeróbica.

The purpose of this study was to verify the existence of learning effect in results of Wingate repeated tests. Twelve cyclists were submitted to two Wingate Tests (TW1 and TW2) with an interval of a week. The added resistance was equivalent to 10% of body mass, the routines were planned to reproduce the same conditions in both tests. Even though the high correlation (0,92), the results showed significant difference for Mean Power (PM), in absolute values (TW1: 579,7 ± 91,0 W vs TW2: 616,9 ± 102,2) and relative values, (TW1: 8,3 ± 0,8 W/kg vs TW2: 8,8 ± 0,9 W/kg) favoring the second test. The evidence demonstrated the existence of learning effect affecting results of anaerobic power.

El objetivo del estudio fue investigar la existencia del efecto del aprendizaje en los resultados de repetidas evaluaciones de Wingate. Doce ciclistas fueron sometidos a dos evaluaciones de Wingate (TW1 e TW2) con intervalo de una semana. La resistencia adicionada fue equivalente a 10% de la masa corporal y las rutinas fueron planeadas para reproducir las mismas condiciones en las dos evaluaciones. Mismo con la correlación de 0,92, los resultados revelaran diferencias significativas para la Potencia Media (PM) en valores absolutos (TW1: 579,7 ± 91,0 W vs TW2: 616,9 ± 102,2 W) y valores relativos (TW1: 8,3 ± 0,8 W/kg vs TW2: 8,8 ± 0,9 W/kg), favoreciendo la segunda evaluación. Eso demuestra la existencia del efecto del aprendizaje influyendo la potencia anaeróbica.

Homogeneidade espacial da precipitação pluvial na bacia hidrográfica do Rio Vacacaí, RS / Spatial homogeneity of pluvial precipitation in Vacacaí river watershed, RS, Brazil

O objetivo, neste trabalho, foi determinar o número mínimo de anos com observações necessários para a obtenção de valores médios dos totais mensais de precipitação pluvial consistentes e a área de abrangência das estações pluviométricas, localizadas na bacia hidrográfica do Rio Vacacaí, estado do Rio Grande do Sul. Foram utilizadas as séries históricas de dados dos totais mensais de 13 estações pluviométricas localizadas na área e no entorno da referida bacia hidrográfica. O número mínimo de anos foi calculado pela relação entre o número de anos com observações e a estabilidade dos coeficientes de determinação. A abrangência das estações foi determinada pela relação dos coeficientes de determinação dos totais mensais de precipitação pluvial entre cada estação e a estação base, no caso Santa Maria, e as distâncias lineares entre a estação base e essas estações. A partir dessas equações, foram determinadas as distâncias entre estações em que há 80%, 85%, 90%, 95% e 99% de concordância dos valores. Constatou-se que, para ter uma razoável precisão nos totais mensais de precipitação pluvial na área da bacia hidrográfica do Rio Vacacaí, são necessários em torno de 30 a 40 anos de observação e que, nos meses de dezembro, janeiro e fevereiro, a abrangência das estações pluviométricas é menor do que 1,0km e nos outros meses uma concordância de 99% é obtida para distâncias de 1,3 a 2,2km, de 95% para distâncias de 6,3 a 11,1km e de 90% para distâncias de 12,5 a 22,2km.

The objective of this research was to determine the minimum number of years with observations needed to obtain the medium number of total monthly consistent precipitation values and the area of coverage of the pluviometric station located in the Vacacaí river watershed, in the Rio Grande do Sul state, Brazil. It were used the historic series of precipitation data of 13 pluviometric stations located in the area and around the watershed. The minimum number of years was calculated from the relation between the number of years with observations and the stability of coefficients of determination. The station's area of coverage was determined from the relation between the coefficients of determination of the total monthly precipitation between each station and the base station (Santa Maria), and the linear distances between the base station and each station. From those equations, the distance between stations in which 80%, 85%, 90%, 95% e 99% of the values has concordance was determined. It was found that, to have a reasonable precision in the total monthly precipitation in the Vacacaí river watershed, it is necessary between 30 and 40 years of observation and, in December, January and February months the coverage of the pluviometric stations is less than 1.0km and on the other months to achieve a precision of 99% distances between 1.3 and 2.2km, 95% distances between 6.3 and 11.1km and 90% for distances between 12.5 and 22.5km.