Bioequivalence and Bioavailability Forum

Dear Ladi

To satisfy EMEA guideline which states that minimum two QC covered within Cmax of that particular period you can take following steps

Firstly monitor around 20% of first subject of the study. if Cmax of both periods of that subjects (at least 67% among them) will cross two QC than no need of additional QC and if its not cross than add one more QC between LQC and MQC. The all procedure must be incorporated in SOP prior to analysis

E.g. if you have to perform analysis of 100 subjects then you can monitor first twenty subjects among them

20% of 100 subjects is 20

if Cmax of both period in 14 (67% of 20) subjects out of that 20 subjects cross two QC level than no need of additional QC and if its not than add one more QC between LQC and MQC. so, in remaining subjects cmax cross two QC levels

Regards,
Ritesh Korat