Incurred sample reanalysis: adjusted procedure for sample size calculation
| Autor: | Katarzyna Buś-Kwaśnik, Piotr J. Rudzki, Michał Kaza |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Computer science
Clinical Biochemistry Sample (statistics) 030226 pharmacology & pharmacy 01 natural sciences Specimen Handling Analytical Chemistry 03 medical and health sciences 0302 clinical medicine Tandem Mass Spectrometry Acceptance testing Statistics Humans General Pharmacology Toxicology and Pharmaceutics Chromatography High Pressure Liquid Reliability (statistics) 010401 analytical chemistry General Medicine Models Theoretical Outcome (probability) 0104 chemical sciences Medical Laboratory Technology Imatinib mesylate Sample size determination Imatinib Mesylate Spectrophotometry Ultraviolet Risedronic Acid |
| Zdroj: | Bioanalysis. 9:1719-1726 |
| ISSN: | 1757-6199 1757-6180 |
| Popis: | Aim: The incurred sample reanalysis (ISR) helps to assure bioanalysis reliability. The regulatory guidelines recommend the reanalysis of up to 10% of the study samples for this test, but not all reanalyses are necessary to evaluate the test result. Materials & methods: We have optimized ISR sample size calculation to eliminate negligible reanalyses. Results: Adjusted procedure eliminates negligible reanalyses – up to 66% of currently analyzed ISRs – without affecting the test outcome. Conclusion: The procedure is universal as it may be applied in the studies compliant with EMA and US FDA requirements, for both small and large molecules. It may assist the evolution of bioanalytical method validation as the current ISR sample size recommendations seem to be ill-matched with the acceptance criteria. |
| Databáze: | OpenAIRE |
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