Bioequivalence and Bioavailability Forum

Dear All,

With regard to TGA submission studies;

As per Australian regulatory guidelines for prescription medicines Appendix 15: Biopharmaceutic studies, under section 6.3.1 Daily calibration standards, it states that "Calibration standards and a sample blank (for example, plasma) are analysed with each batch of study samples on a daily basis"

And

in sec 6.3.2 Quality control samples states that "Control samples at three or more concentrations covering the expected concentration range (for example, one within 3x of the LOQ, one in the mid-range, and one at the high end of the range) are prepared in plasma in bulk at the time of pre-study assay validation, or at the time of study sample collection, and are aliquoted into storage vessels and stored deep frozen"

We have performed one Precision and accuracy batch with freshly spiked calibration standards and four levels of bulk spiked quality control samples (LOQQC, LQC, MQC and HQC) under method validation.

Please let us know for study sample analysis, is it required to spike calibration standards on a daily basis or can we use bulk spiked calibration standards, because now European Union guidelines adopted for TGA submissions

Thanks & regards,
Avinash