Evaluation of measurement uncertainty of the results from dissolution test of letrozole tablets using combined approaches
This paper presents two simple combined approaches for estimating measurement uncertainty of dissolution tests of tablets containing 2.5 mg letrozole. The first approach integrates a top-down approach based on data from the validation study with the data from the qualification of the dissolution a...
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| Format: | Article |
| Language: | English |
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University Ss Cyril and Methodius in Skopje, Faculty of Pharmacy and Macedonian Pharmaceutical Association
2024-12-01
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| Series: | Makedonsko Farmacevtski Bilten |
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| Online Access: | http://bulletin.mfd.org.mk/volumes/Volume%2070_2/70_2_002.pdf |
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| author | Sonja Mandovski Hrisanta Godzo Jelena Acevska Natalija Nakov Jasmina Tonic-Ribarska Katerina Brezovska |
| author_facet | Sonja Mandovski Hrisanta Godzo Jelena Acevska Natalija Nakov Jasmina Tonic-Ribarska Katerina Brezovska |
| author_sort | Sonja Mandovski |
| collection | DOAJ |
| description | This paper presents two simple combined approaches for estimating measurement uncertainty of dissolution tests of tablets containing
2.5 mg letrozole. The first approach integrates a top-down approach based on data from the validation study with the data from the
qualification of the dissolution apparatus. The second top-down approach combines the data from participation in PTS with the uncertainty related to standard and sample solutions preparation. Additionally, a bottom-up approach for estimating the measurement uncertainty was applied to identify the variability sources and to evaluate their contributions to the combined standard uncertainty. The results indicate that the main contributor to the combined standard uncertainty is the standard uncertainty related to the dissolution apparatus (81.5%), followed by the method precision (8.7%). Both combined approaches (validation data with instrument qualification and PTS data with the uncertainty of testing solutions) resulted in similar measurement uncertainty estimates to those obtained with the bottom-up approach, suggesting that either approach can be effectively used for uncertainty estimation, depending on data availability.
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| format | Article |
| id | doaj-art-c8a08d00ac61479090ac2a2a43f08a3b |
| institution | DOAJ |
| issn | 1409-8695 1857-8969 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | University Ss Cyril and Methodius in Skopje, Faculty of Pharmacy and Macedonian Pharmaceutical Association |
| record_format | Article |
| series | Makedonsko Farmacevtski Bilten |
| spelling | doaj-art-c8a08d00ac61479090ac2a2a43f08a3b2025-08-20T02:44:17ZengUniversity Ss Cyril and Methodius in Skopje, Faculty of Pharmacy and Macedonian Pharmaceutical AssociationMakedonsko Farmacevtski Bilten1409-86951857-89692024-12-0170291610.33320/maced.pharm.bull.2024.70.02.002Evaluation of measurement uncertainty of the results from dissolution test of letrozole tablets using combined approachesSonja Mandovski0Hrisanta Godzo1Jelena Acevska2Natalija Nakov3Jasmina Tonic-Ribarska4Katerina Brezovska5Faculty of Pharmacy, Ss. Cyril and Methodius University in Skopje, Mother Theresa 47, 1000 Skopje, Republic of N. MacedoniaFaculty of Pharmacy, Ss. Cyril and Methodius University in Skopje, Mother Theresa 47, 1000 Skopje, Republic of N. MacedoniaFaculty of Pharmacy, Ss. Cyril and Methodius University in Skopje, Mother Theresa 47, 1000 Skopje, Republic of N. MacedoniaFaculty of Pharmacy, Ss. Cyril and Methodius University in Skopje, Mother Theresa 47, 1000 Skopje, Republic of N. MacedoniaFaculty of Pharmacy, Ss. Cyril and Methodius University in Skopje, Mother Theresa 47, 1000 Skopje, Republic of N. MacedoniaFaculty of Pharmacy, Ss. Cyril and Methodius University in Skopje, Mother Theresa 47, 1000 Skopje, Republic of N. MacedoniaThis paper presents two simple combined approaches for estimating measurement uncertainty of dissolution tests of tablets containing 2.5 mg letrozole. The first approach integrates a top-down approach based on data from the validation study with the data from the qualification of the dissolution apparatus. The second top-down approach combines the data from participation in PTS with the uncertainty related to standard and sample solutions preparation. Additionally, a bottom-up approach for estimating the measurement uncertainty was applied to identify the variability sources and to evaluate their contributions to the combined standard uncertainty. The results indicate that the main contributor to the combined standard uncertainty is the standard uncertainty related to the dissolution apparatus (81.5%), followed by the method precision (8.7%). Both combined approaches (validation data with instrument qualification and PTS data with the uncertainty of testing solutions) resulted in similar measurement uncertainty estimates to those obtained with the bottom-up approach, suggesting that either approach can be effectively used for uncertainty estimation, depending on data availability. http://bulletin.mfd.org.mk/volumes/Volume%2070_2/70_2_002.pdfdissolution testmeasurement uncertaintybottom-up approachcombined top-down approach |
| spellingShingle | Sonja Mandovski Hrisanta Godzo Jelena Acevska Natalija Nakov Jasmina Tonic-Ribarska Katerina Brezovska Evaluation of measurement uncertainty of the results from dissolution test of letrozole tablets using combined approaches Makedonsko Farmacevtski Bilten dissolution test measurement uncertainty bottom-up approach combined top-down approach |
| title | Evaluation of measurement uncertainty of the results from dissolution test of letrozole tablets using combined approaches |
| title_full | Evaluation of measurement uncertainty of the results from dissolution test of letrozole tablets using combined approaches |
| title_fullStr | Evaluation of measurement uncertainty of the results from dissolution test of letrozole tablets using combined approaches |
| title_full_unstemmed | Evaluation of measurement uncertainty of the results from dissolution test of letrozole tablets using combined approaches |
| title_short | Evaluation of measurement uncertainty of the results from dissolution test of letrozole tablets using combined approaches |
| title_sort | evaluation of measurement uncertainty of the results from dissolution test of letrozole tablets using combined approaches |
| topic | dissolution test measurement uncertainty bottom-up approach combined top-down approach |
| url | http://bulletin.mfd.org.mk/volumes/Volume%2070_2/70_2_002.pdf |
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