Bioequivalence and Bioavailability Forum

Hi all,
Would like to know your opinion regarding the biowaiver of the Simvastatin oral suspension.

Linear PK is reported in the mentioned dose range
Site of action of the drug is liver and is mainly getting accumulated in the liver
It is reported that, plasma concentration of the drug is correlated with the adverse event of the drug but not with the efficacy
In reported literature, 30 % increase in AUC did not cause change in the efficacy
Excipients in the formulation are unlikely to affect the GI absorption
Drug is not getting accumulated in the body
Absorption is constant over the dose range of 20-80 mg for small particles (20 µm)
BCS class II

If the 90 % or more particles in the formulation have particle size less than 20 µm and test drug shows similar invitro disso with the ref can biowaiver be applied in this particular case?

Regards,
PJS

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Edit: Category changed. [Helmut]