Affiliation:
1. Pharmacology Department, Pharmaceutical Research Institute, 8 Rydygiera Street, Warsaw 01–793, Poland
Abstract
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.
Subject
Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry
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