Skip to main page content
Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2017 Nov;9(21):1719-1726.
doi: 10.4155/bio-2017-0142. Epub 2017 Nov 9.

Incurred Sample Reanalysis: Adjusted Procedure for Sample Size Calculation

Affiliations

Incurred Sample Reanalysis: Adjusted Procedure for Sample Size Calculation

Piotr J Rudzki et al. Bioanalysis. .

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.

Keywords: ISR; bioanalytical method validation; incurred sample reanalysis; pharmacokinetics.

Similar articles

See all similar articles

Cited by 2 articles

LinkOut - more resources

Feedback