(Summarize the method to verify carry-over & results) 7.5 Standard curves (State location in submission of tabulated raw data and back calculated data with descriptive statistics) a) List number and concentration of calibration standards used b) Describe the regression model used including any weighting c) List the back-calculated concentrations of the calibration standards of the validation runs (highlight the values outside of the acceptance range, e.g., 15%, except 20% for LLOQ) 7.6 Quality control samples a) Identify the concentrations of the QC samples and the storage conditions employed prior to their analysis 7.7 Precision and accuracy during validation a) Summarize inter-day/inter-run accuracy and precision of the calibration standards during assay validation b) Summarize inter-day/inter-run accuracy and precision of the calibration standards during assay (If applicable) c) Summarize inter-day/inter-run and intra-day/intra-run accuracy and precision of the QC samples during assay validation d) Summarize inter-day/inter-run and intra-day/intra-run accuracy and precision of the QC samples during assay re-validation (If applicable)
(Summarize the method to verify carry-over & results) 7.5 Standard curves (State location in submission of tabulated raw data and back calculated data with descriptive statistics) a) List number and concentration of calibration standards used b) Describe the regression model used including any weighting c) List the back-calculated concentrations of the calibration standards of the validation runs (highlight the values outside of the acceptance range, e.g., 15%, except 20% for LLOQ) 7.6 Quality control samples a) Identify the concentrations of the QC samples and the storage conditions employed prior to their analysis 7.7 Precision and accuracy during validation a) Summarize inter-day/inter-run accuracy and precision of the calibration standards during assay validation b) Summarize inter-day/inter-run accuracy and precision of the calibration standards during assay (If applicable) c) Summarize inter-day/inter-run and intra-day/intra-run accuracy and precision of the QC samples during assay validation d) Summarize inter-day/inter-run and intra-day/intra-run accuracy and precision of the QC samples during assay re-validation (If applicable)
BTIF_Sept2018.docx