Bioequivalence and Bioavailability Forum

Hi Helmut,

Thank you for the reply..,

❝ ❝ […] the agency …

❝

❝ May I ask: Which agency?

The FDA

❝ … recommend to demonstrate comparative PK in the absence of bioequivalence.

❝

❝ Do I get you right: The study was planned to demonstrate BE, failed, and now you were asked about ‘comparative PK’? I never came across such a term.

The following is the guidance....

To use pharmacokinetics (PK) bridging only, you should establish bioequivalence between test drug the listed drug under both fasting and fed conditions.

If the bioequivalence cannot be established due to different food effect or other reasons, you should demonstrate comparable PK and pharmacodynamics (PD) between Test and reference.

To establish "comparable PK" between test and reference, the active drug exposure (AUC, Cmax and Ctrough) of test at the proposed dosing regimen should be comparable with the listed drug.

Thanks