Bioequivalence and Bioavailability Forum

Dear Compliance
In general in-study method performance is evaluated using data generated from accepted calibration curves, which are used to determine the concentration of the analyte in the study samples. I guess your calibration curve parameters (slope, y-intercept, correlation coefficient) from the accepted analytical batches as well as back-calculated concentrations of calibration standards, between-run accuracy and precision of quality control samples yield reliable results. If the number of failed analytical runs, QC results outside acceptance criteria and reassays is low and if your method has produce 98% ISR results then the robustness and reproducibility of your method is demonstrated. In this context I do not understand your concern: "however the RLD performance is different in all two pilot study and last conducted pivotal study." In comparison to the test drug? Absolute values? Please explain.
Kind regards
Dan