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| Nascimento,Michele Cardoso do; Abreu,Clarice Lima do Canto; Costa,Rodrigo Netto; Delgado,Wlamir Correa de Moura; Fernandes,Isabella. |
| 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... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: Recombinant Human Erythropoietin; Biological; Quality Control; Sanitary Surveillance. |
| Ano: 2015 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1516-89132015000400562 |
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| Nóbrega,Andréa Martins da; Alves,Eloisa Nunes; Presgrave,Rosaura de Farias; Costa,Rodrigo Netto; Delgado,Isabella Fernandes. |
| In an attempt to build the evaluation strategies to assess the human eye irritation, a reassessment of some in vitro tests is necessary, particularly concerning the non-irritants, mild and moderate irritants. Thus, the correlations between results obtained from the Draize test with the in vitro methods HET-CAM (Hens Egg Test-Chorion Allantonic Membrane) and RBC haemolysis assay to assess the ocular irritancy potential of 20 eye drops were examined. Parameters such as accuracy (%) and specificity (%) were determined. All results were correlated with RBC correctly with the results obtained in the Draize test. The HET-CAM presented four false-positive results, showing a tendency of data overestimation. Despite the high specificity provided mainly by the RBC,... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: Alternative methods; Eye irritation; Draize Test; Low-irritant; HET-CAM; RBC. |
| Ano: 2012 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1516-89132012000300008 |
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| Costa,Rodrigo Netto; Abreu,Clarice Lima do Canto; Presgrave,Rosaura Farias; Alves,Eloisa Nunes; Presgrave,Octavio Augusto França; Delgado,Isabella Fernandes. |
| 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% 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... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: Draize test; Ocular irritation; TPC; Shampoos; SIRC; 3T3. |
| Ano: 2011 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1516-89132011000600008 |
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