Bioequivalence and Bioavailability Forum

Dear Astea,

I think this thread should be useful

❝ We've got CI for Cmax of about 115-140% that is far from the required.

It would be a main problem. The λz calculation doesn't make any sense in this case.

❝ We've got curves similarily to those pointed in the article Upadhyaya V., et al., Determination of mycophenolic acid in human plasma by ultra performance liquid chromatography tandem mass spectrometry, Journal of Pharmaceutical Analysis 2014; 4(3):205-216)

The mean plasma profiles look very well in the mentioned article. May be I didn't understand something...

❝ ❝ Yes. It might well be possible that you see in some patients no second peak, the second one smaller than the first one or vice versa. This behavior may even change within the same patient. For a nice PK model see Prémaud et al. (2005).*

❝

❝ All the patients have second peak in the profile of the curve and this peak is significally smaller than the first.

❝ Thank you for the link but full text of the article is not available.

I can help you with this article, please contact me. By the way no new information is presented there

❝ Are there any official documents (like FDA recommendations or something else) where I can find the statement that half life calculation is incorrect and isn't neccessary in the case when we have lack of information about the terminal phase of the curve?

Half life isn't a primary metric, I doubt there's one.
The good solution is to provide two parts of AUC analysis: with and without estimable λz (as Helmut wrote).