Bioequivalence and Bioavailability Forum

Dear all,

As per guidelines "Non-compartmental methods should be used for determination of pharmacokinetic parameters in
bioequivalence studies. The use of compartmental methods for the estimation of parameters is not
acceptable"

why the non-Compartmental analysis is preferred over compartmental ones ?

also use of PK/PD models to establish BE, as per my understanding BE is about detecting differences between formulations in healthy volunteers and from that, it can be extended to patients population.

PK/PD models can't be used to detect such differences? and conclude BE?



Also regarding use of pop/INDV BE, most FDA OGD drafts revolve around use of average BE in most cases and in case of HVDP, reference scaling and/or variability comparison -for FDA and SCABEL for EMA- is preferred due to number of subjects that would be needed.

when pop/indv BE is feasible or applicable? does the nature of the drug molecule determine such approach? also any published BE studies based on either of them.

Thanks in advance.