Bioequivalence and Bioavailability Forum

Dear Dan,
Thank you for your reply.

Please find below the requested information:

❝ a. What was the CVintra for Cmax?

25

❝ b. I guess it is a drug with a very long elimination half live, right? Did you use truncated AUC?

Median t1/2: 20.2±16.19h. The product is an IR product and PK sampling was done till 72h.

❝ c. If CVintra for Cmax << AUC and short t1/2, have you performed any outlier testing?

I dont have information on this. Will update when I recive them.

❝ d. What was the point estimator (T/R ratio) for AUC? Maybe the formulation difference is too big to just calculate with CVintra and the usual delta 5%.

116 (T/R ratio) for AUC

Kind regards,
Tina

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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! [Helmut]