An exact test for analytical bias detection

The Role of and the Place of Method Validation in Drug Analysis Using Electroanalytical Techniques

“…If the proposed electroanalytical method and the reference method agree, this is good evidence they both work for the studied compound and application media such dosage forms, biological material etc [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][59][60][61][62]. For obtaining the accuracy from these results, student-t and F tests are generally used for statistical comparison methods [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][59][60][61][62]. Accuracy should be reported as percent recovery by the assay of known amount addition of analyte in the sample or as the difference between the mean and the accepted true value together with the confidence intervals and calculated student-t and F results.…”

“…Analyte reference standard is added to a blank matrix media which can be called as placebo, at different concentration levels. Using this technique, the possible interferences and potential effects between the inactive ingredients and pharmaceutically active compound can be investigated [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][59][60][61][62]. The recovery at each working concentration level is determined by comparison to the known amount added.…”

“…A minimum of three repeated experiments should be realized at each level. Furthermore, the results which are obtained using spiked into the blank matrix method can be converted as percent recovery results and they reported with their RSD% and bias% values for showing the accuracy of the proposed method [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][59][60][61][62].…”

“…The difference between the spiked and unspiked sample results is the recovered part of the added analyte, which can be compared with the known amount added. In general, for standard addition using this technique, a good approach is to add 25, 50 and 100% of the expected working compound concentration to the matrix in different experiments [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][59][60][61][62]. The measured amounts are reported versus the amount added with the average percent recovery results, RSD% and bias% results.…”