Bioequivalence and Bioavailability Forum

Hi Loky do,

❝ For certain products, ema product-specific bioequivalence guidance states that the main PK variables: AUC_0-72,...etc (also stated in the study protocol),

Not only the ones in product-specific guidances but all IR products (BE-GL page 9):

A sampling period longer than 72 h is therefore not considered necessary for any immediate release formulation irrespective of the half life of the drug.

❝ Is that mean any subject who miss 72 h will be excluded from AUC_0-72 calculations?

No. If you have a reliable estimate of λ_z (at least three concentrations), you may use an estimate – if the exact method is stated in the protocol. E.g., in Phoenix/WinNonlin specify pAUC72 and you are fine. There are many posts in the forum discussing the details.

❝ if yes, there will be around 25% of subjects missed this interval, is that will be acceptable?

In principle yes but as an assessor I would question the clinical performance of the CRO.