Bioequivalence and Bioavailability Forum

Hi pash,

❝ For HVD drugs recently Canada regulatory has published a notice proposing to adopt an average bioequivalence approach to HVDP with expanding limits based on the within-subject variability of the reference product.

Do you have a reference? I only know the archived notice Detlew mentioned. The FDA’s model sometimes fails to converge for data of the partial replicate design. Either use one of the full replicates designs (RTRT|TRTR or RTR|TRT) instead or change the random section where the structure of the variance-covariance matrix is specified from FA0(2) to FA0(1).