Bioequivalence and Bioavailability Forum

Hi Pharma_88,

❝ ❝ ❝ Further, what is the BE limit for such drugs?

❝ ❝

❝ ❝ It depends on \(\small{s_{wR}}\) observed in the study, i.e., reference-scaling is applied. Furthermore – irrespective of passing the scaled limits – the study has to pass 80.00–125.00% as well and the upper confidence limit of \(\small{\sigma_{wT}/\sigma_{wR}}\) has to be ≤2.5.

❝

❝ its common for all NTI or its varies from drug to drug?

The former. Check the guidances I linked above. Maybe there are more, do your homework.

There are exceptions: “Highly variable narrrow therapeutic index drugs”. AFAIK:

• Dabigatran
  
• Rivaroxaban

2×2×4 design, conventional ABE with 80.00–125.00%, upper CL of \(\small{\sigma_{wT}/\sigma_{wR}}\) ≤2.5.
Certain inclusion criteria to decrease risk of bleeding (prothrombin time and activated partial thromboplastin time within their normal ranges, creatinine clearance ≤50 mL/min).