RESUMO
A eritropoietina humana recombinante (rhEPO) é um hormônio glicoproteico. Diante da gama de produtos contendo rhEPO disponíveis no mercado, da abrangência da indicação terapêutica e das características dos usuários de rhEPO, o ensaio de atividade biológica é de grande importância para o processo de liberação de lotes deste produto. O teste de potência é uma avaliação laboratorial para averiguar a eficácia do produto final, recomendada pela Farmacopeia Europeia (Ph. Eur.). Este trabalho teve como objetivo avaliar a concordância entre os valores de potência biológica obtidos quando a linhagem de camundongos preconizada pela Ph. Eur. (B6D2F1) foi utilizada em comparação com a Swiss Webster (SW). Vinte e dois lotes foram testados usando-se estas duas linhagens, e 44 ensaios válidos foram obtidos com resultados satisfatórios. Em nenhuma das análises houve necessidade de efetuar repetição de ensaios, bem como a combinação de resultados. A variação entre linhagens e a veracidade foram avaliadas, obtendo-se os seguintes resultados: Coeficiente de Variação (CV) < 10 %; Erro Relativo % (ER %) < 10 %, respectivamente. As linhagens testadas geraram resultados homogêneos sem diferença estatisticamente significativa entre elas. A linhagem SW mostrou características adequadas para ser empregada como alternativa à linhagem B6D2F1 na avaliação da potência biológica de rhEPO...
Assuntos
Animais , Camundongos , Eritropoetina , Linhagem , Vigilância SanitáriaRESUMO
In this study, we compared the results of potency determination of recombinant human erythropoietin (rhEPO) obtained between 2010 and 2012 by the National Institute of Quality Control in Health (INCQS/Fiocruz), i.e., the National Control Laboratory (NCL), and by a manufacturer of rhEPO. In total, 47 different batches of commercially prepared rhEPO (alpha isoform) were analyzed. All results, including those of the control and warning limits, remained within the limits recommended by European Pharmacopoeia (Ph. Eur.). All relative error (RE) values were less than ± 30%, wh ereas most were approximately ± 20%. Applying the Bland-Altman plot, only two of 47 values remained outside the limits of agreement (LA). In addition, agreement of potency determination between INCQS and the manufacturer coefficient of variation of reproducibility (% CVR) was considered satisfactory. Taken together, our results demonstrate (i.) the potency assay of rhEPO performed at INCQS, is standardized and controlled, (ii.) the comparison of our results with those of the manufacturer, revealed an adequate inter-laboratory variation, and (iii.) the critical appraisal proposed here appears to be a feasible tool to assess the reproducibility of biological activity, providing additional information regarding monitoring and production consistency to manufacturers and NCLs.
RESUMO
The aim of this work was to determine the correlation between results obtained from the Draize test and from the Total Protein Content Determination (TPC) to assess the ocular irritancy potential of 20 shampoos. For TPC, two established cell lines (SIRC and 3T3) were used. The concentration that induced 50 percent inhibition relative to controls (IC50) was calculated for each product. Among shampoos tested with SIRC, only one had a false positive result. However, for the 3T3, three false-negative results were found. Pearson coefficient related to the in vivo value of maximum average score (MAS) was -0.58 (p=0.007) with SIRC and -0.73 (p=0.007) with 3T3. These results showed that the TPC assay was capable to predict the ocular irritant potential of shampoos, and therefore was a promissory tool to be used as a preliminary assay for the detection of irritant products and to be part of a battery of screening tests to minimize the animal use in the Draize Test.