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Incurred sample reanalysis at GSK: what have we learned?
Scott G Summerfield1, Matthew Barfield1, Stephen A White1
1Department of Bioanalysis, Immunogenicity & Biomarkers, GlaxoSmithKline R&D, Park Road, Ware, SG12 0DP, UK.
Bioanalysis
|October 17, 2018
Summary
Incurred sample reanalysis (ISR) studies show that while most bioanalytical assays are reliable, a small fraction fail, impacting data integrity. Future debate should focus on ISR
Area of Science:
- Bioanalysis
- Pharmacokinetics
- Drug Development
Background:
- Incurred sample reanalysis (ISR) is crucial for validating bioanalytical methods in drug development.
- A decade of internal bioanalytical data provides a substantial dataset for evaluating ISR outcomes.
Purpose of the Study:
- To review the outcomes of incurred sample reanalysis (ISR) studies over ten years.
- To identify the root causes of ISR failures and assess the value of ISR across different development stages.
Main Methods:
- Review of over 1000 bioanalytical pharmacokinetic endpoints from internally supported studies.
- Analysis of 26 studies that failed predefined ISR acceptance criteria.
- Categorization of root causes for ISR failures, including assay variability, range, and sample homogeneity.
Main Results:
- 26 out of 1000+ bioanalytical studies failed ISR criteria.
- Five datasets were rejected due to instability or preanalytic contamination.
- Most failures were due to methodological issues, but data variability remained acceptable for decision-making.
Conclusions:
- ISR is valuable in early and late drug development stages for assay reliability and data pivotal to submission.
- The value of ISR in intermediate development stages warrants further discussion, questioning industry conservatism.
- Future debate should address the necessity and application of ISR in intermediate development phases.
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