Data reconciliation connected to guard bands to set specification limits related to risk assessment for radiopharmaceutical activity.

Radiopharmaceuticals have been used to diagnose several diseases, particularly because the procedure is non-invasive. However, it is important that the correct amount of radiopharmaceutical is used to avoid inaccurate diagnostic results and suboptimal therapeutic outcomes. The amount of the radiopharmaceutical is measured when produced (by the supplier) and a second time (by the receiver), before it's use. When measured at the receiver, the result is corrected for its normal radioactivity decay. Even then, it is possible that both measurements should be considered nominal different or even statistically different when compared through various statistical tools. This research combines two innovative techniques in the field of clinical metrology. The first technique is data reconciliation, which not only enhances measurement accuracy but also reduces measurement uncertainty. The second technique involves using uncertainty information to establish specification limits for compliance assessments. In this way, our proposal aimed to minimize the risk of making incorrect decisions regarding the conformity of the concentration of radiopharmaceutical activity, that is, rejecting an item or batch that is within specification or accepting an item or batch that is outside of specification. A spreadsheet, based on these metrology fundamentals, is available to help the user with the calculations, presenting numerical and graphical results for some common radioisotopes. Reliable specification limits can be calculated and used to determine if the radiopharmaceutical is in accordance with its proposed application.

Validation of impregnation process for homeopathic globules by spectrophotometric-UV method

We compared the impregnation techniques for globules according to the Manual of Technical Norms for Homeopathic Pharmacies (MNTFH) of the Association of Homeopathic Pharmacists (ABFH), Brazilian Homeopathic Pharmacopoeia (FHB) and variations of these techniques. The variables were evaluated in this procedure, three different sizes of globules (N o . 3, 5 and 7), the hydroalcoholic solution of 70% (v/v) Minoxidil 2% (w/v) was used to impregnate the globules in concentrations of 2, 3, 4, 5% (v/w) and the impregnation at 10 %(v/w) was used hydroalcoholic solutions at 70, 80 and 90% (v/v), and four impregnation techniques various ( A -glass, B -paper, C -cup and D -FHB). As the results of content uniformity did not demonstrate a normal distribution, the one way ANOVA and a nonparametric statistical model were used for evaluation. Considering the average, the standard deviation (SD), the individual variance of each group and the principal components analysis graphs (PCA), it was observed that the “A” impregnation of globules technique, with 5% (v/w) of the impregnation concentrations and the No.5 globule presented the best uniformity of dose. As to the drying, there was a need to use a heat source.

Compararam-se as técnicas de impregnação para glóbulos segundo o Manual de Normas Técnicas para Farmácias Homeopáticas (MNTFH) da Associação Brasileira de Farmacêuticos Homeopatas (ABFH), Farmacopeia Homeopática Brasileira (FHB) e variações destas técnicas. As variáveis avaliadas neste processo foram: três tamanhos diferentes de glóbulos (n.º 3, 5 e 7); a solução hidroalcóolica a 70% (v/v) de minoxidil a 2% (p/v) foi utilizada para impregnar os glóbulos nas concentrações de 2, 3, 4, 5% (v/p) e na impregnação a 10% (v/p) utilizaram-se as soluções hidroalcóolicas a 70, 80 e 90% (v/v); e quatro técnicas de impregnação diferentes ( A -vidro, B -papel, C -copo e D -FHB). A impregnação foi validada através da uniformidade de dose por conteúdo, sendo o minoxidil a substância quantificada. Como os resultados da uniformidade de dose por conteúdo não demonstraram distribuição normal, utilizaram-se o One way ANOVA e um modelo estatístico não paramétrico para sua avaliação. Considerando-se a média, o desvio padrão (DP), a variância individual de cada grupo e os gráficos de análise de componentes principais (ACP), observou-se que a impregnação que utilizou o glóbulo nº5, a concentração para impregnação de 5% (v/p), graduação alcoólica de 70% (v/v) e técnica “A” apresentou a melhor uniformidade de dose. Quanto à secagem, verificou-se a necessidade do uso de uma fonte de calor.