ARISENTO Insights
Practical knowledge for bioanalytical scientists
Guides and free tools for the people who develop, validate, run, review and approve bioanalytical methods - written from experience at the bench and in data review.
ISR calculator (ICH M10)
Number of ISR samples, % difference per pair and the two-thirds rule - in your browser, nothing uploaded.
Open → Data review · 7 minICH M10 run acceptance criteria
The calibration and QC rules every chromatographic run must meet under ICH M10 - with a worked example and the mistakes that cause failed runs.
Read the guide →Study sample analysis · 8 minIncurred sample reanalysis (ISR) under ICH M10
When ISR is required, how many samples to repeat, the % difference formula, the 2/3 rule - and how to investigate a failed ISR.
Read the guide →LC-MS/MS troubleshooting · 7 minCarryover and internal standard response in LC-MS/MS bioanalysis
The ICH M10 carryover limits, how to test for carryover in every run, and how to monitor and investigate internal standard variability.
Read the guide →Method development · 9 minMatrix effect in LC-MS/MS bioanalysis
What causes ion suppression and enhancement, how ICH M10 expects matrix effect to be evaluated, and the practical fixes that work at the bench.
Read the guide →Method development · 9 minStabilising unstable analytes
Why some analytes disappear between the clinic and the mass spectrometer - and the stabilisers and handling steps that keep them intact.
Read the guide →Method validation · 10 minICH M10 bioanalytical method validation checklist for chromatographic methods
Every validation parameter ICH M10 expects for an LC-MS/MS method - with the experiment design and acceptance criteria in one place.
Read the guide →ARISENTO Insights is published by Autofai Technologies Private Limited, the makers of ARISENTO bioanalytical software.