Bioequivalence and Bioavailability Forum

❝ If you aimed for a submission in Canada I think the

❝ "Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects" paragraph 2.1.1.6 Critical dose drugs applies.

Thnx a lot for your reply.
As per "Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects" paragraph 2.1.1.6 Critical dose drugs gives criteria of NTI drugs.
Actually for molecule like rivaroxaban(Anticoagulant) its OGD says that,
Applicants should use the average BE approach with BE limits of 80-125%. The within-subject variability of test (T) and reference (R) products should be compared, and the upper limit of the 90% confidence interval for the test-to-reference ratio of the within-subject variability should be ≤ 2.5.

So, should i use "Guidance Document - Comparative Bioavailability Standards: Formulations Used for Systemic Effects" paragraph 2.1.1.6 Critical dose drugs?

Regards,
Nirav

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Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]