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FDA (1) Forced Degradation (1) HPLC (8) ICH (18) Lifecycle (11) Method development (3) Methods (1) MHRA (2) MTS (8) MTS Helpdesk (18) OOS/OOT (3) Procedures (1) Stability (3) Transfer (1) Troubleshooting (1) Validation (21) Verification (1) Video (5) Webinar (2)
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Confidence Intervals for Method Validation Data
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?
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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…
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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?
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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?
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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.
FDA (1) Forced Degradation (1) HPLC (8) ICH (18) Lifecycle (11) Method development (3) Methods (1) MHRA (2) MTS (8) MTS Helpdesk (18) OOS/OOT (3) Procedures (1) Stability (3) Transfer (1) Troubleshooting (1) Validation (21) Verification (1) Video (5) Webinar (2)