| Full text | |
| Author(s): |
Total Authors: 2
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| Affiliation: | [1] Univ Sao Paulo, Dept Farm, Fac Ciencias Farmaceut, Av Prof Lineu Prestes 580, Cidade Univ, BR-05508000 Sao Paulo, SP - Brazil
Total Affiliations: 1
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| Document type: | Journal article |
| Source: | MEASUREMENT; v. 183, OCT 2021. |
| Web of Science Citations: | 0 |
| Abstract | |
The reliability of qualitative analysis has been much less studied than quantitative analysis. Thus, the aim of the work was to propose a procedure to estimate the risk of false identification of chemical compounds using chromatographic and spectrophotometric analytical procedures. For the chromatography test, the Monte Carlo method was used to simulate the relative retention time of the tested substances considering the chromatographic parameters. For the UV spectrometry test, the spectra of test sample and standard were decomposed, and the simulation of each peak was obtained by using a normally distributed random generator. The probabilities of true positives and false positives were estimated using MS-Excel spreadsheets. The estimation of true positive and false positive results is relevant to guarantee the reliability of qualitative results. In addition, the likelihood ratio was calculated to support the evidence of a positive identification result, which is a relevant issue to distinguish between original and counterfeit or substandard medicines. (AU) | |
| FAPESP's process: | 19/16206-3 - Risks of false decisions due to the measurement uncertainties in the evaluation of pharmaceutical equivalence |
| Grantee: | Felipe Rebello Lourenço |
| Support Opportunities: | Regular Research Grants |