MTS HELPDESK:
ICH Q2(R2) directs that for the results of accuracy and precision, the confidence interval should be compared to the acceptance criteria. How are these confidence intervals calculated?
Author: MTS
JPAG Symposium: Analytical Method Transfer Case Studies
The MTS consultant, Oona McPolin, delivered a presentation entitled: ‘Case Studies from Analytical Method Technology Transfer Studies: Learning from Experience’, as part of the JPAG Symposium on ‘Analytical Method Technology Transfers’ at the Royal Society of Chemistry in London on Thursday 9th July 2026. Click on the button below to view the slides for the presentation. Six AMT case studies are detailed with associated learning points.
Reporting OOS Phase 2 Retest Results
MTS HELPDESK:
What results should be reported on the Certificate of Analysis for an inconclusive OOS phase 2 investigation where the retest results are acceptable?
Why not Retest in Phase 1 OOS Investigation?
MTS HELPDESK:
Why does the guidance from MHRA regarding investigation of out of specification (OOS) results not allow retesting in phase 1?
JPAG Symposium: Analytical Method Technology Transfers
The MTS consultant, Oona McPolin, will be presenting at the upcoming JPAG symposium at the RSC in London on the topic of analytical method transfer.
New dates in 2026 for the course, ‘What’s New in ICH Q2(R2) and Q14?’
We have added two new dates in 2026 for our course, ‘What’s New in ICH Q2(R2) and Q14?’ in September and November. On this course you will learn about the recent changes to the ICH guidance, Q2(R2), ‘Validation of Analytical Procedures’, and about the new guidance Q14, ‘Analytical Procedure Development’.