Coffee Chat Q&A follow up: reporting requirements for ICH M10

Thank you to everyone who attended our Coffee Chat ‘Reporting requirements for ICH M10. Below are the responses from our speakers to the questions posed by our audience during the live event. We hope this is a useful resource and thank those who submitted these thoughtful questions.

(Q) Do you recommend performing incurred sample reanalysis (ISR) for pharmacodynamic (PD) analysis?

(A) Biomarkers are outside the scope of the M10 document, so we recommend setting a procedure in your standard operating procedures (SOPs).

(Q) You mentioned that ICH M10 was targeted to bioavailability / bioequivalence (BA/BE). Are some of the requirements such as dilution quality control (QC) on each run and all chromatograms in the report not required for all clinical trials as was the case for the FDA (if not explicitly written)?

(A) The ICH M10 calls out to report more data for BA/BE study than the Bioanalytical Method Validation (BMV) required. For instance, the BMV stated 20% of serially selected subjects, versus the ICH M10 that calls for 100% of all chromatograms. The delineation in Table 1 of the M10 clearly states where BA/BE has additional requirements.

(Q) Are there now clear pass/fail criteria for cross-validation? The European Medicines Agency (EMA) had simple ISR rules to judge this.

(A) While EMA lists accuracy and precision requirements for the QC samples utilized between methods, no such definitive pass/fail criteria are included in the ICH M10 (Section 6.2). The M10 only states bias is to be assessed and lists multiple methodologies for determining bias.

(Q) Documentation: how do you interpret the reporting requirement for sample tracking to have “Analytical site storage condition and location”?

(A) The language didn’t change between BMV Table 2 and M10 Table 1; the report should include where the samples were stored during bioanalytical sample analysis and under what condition(s).

(Q) In Table 1 in ICH M10, where it references Reanalysis/Repeat Analysis and requires reporting of original and reassay values; does that include samples that have been reassayed due to the original run being rejected overall?

(A) As it is not entirely clear what is required by the M10, we suggest that the reporting of reassays is defined in your SOP pertaining to reporting of regulated studies.

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