(edited by mittyri on 2018-10-25 20:29)
Posting: # 19493
I have problem how to calculate the Cmax1 Cmax2 Cmin Tmax1 Tmax2 and Tmin Auc0-tau1 Auc0-tau2 and Auct in phoenix for each subject.
Here i tried one method
dosing ( dose-20mg/ time of dosing-0/ and tau-24hr)
i got cmin and tmin.... but we manually know that o.oo hr is tmin and BLQ=0.000, so it will be the Cmin.
But sponsor want 1st cmax1 and cmin then again Cmax2. by the same way he want tmax1 and tmin and again tmax2.
kindly give some idea how to solve this
Edit: Category changed; see also this post #1. Please follow the Forum’s Policy [Mittyri]
Posting: # 19494
If you want to show your project with a problem, get the detailed answer, please try to submit your question to Certara forum.
Bebac platform is good place for discussion and some coding, but I really doubt that someone is ready to help you with simple Data/NCA manipulation in Phoenix here.
Posting: # 19515
Rufus, Mittyri is absolutely right. If you can't understand the examples; (C:\Program Files (x86)\Certara\Phoenix\application\Examples\WinNonlin), discussed in the user manuals; (Help menu or C:\Program Files (x86)\Certara\Phoenix\docs); for Phoenix I would email Certara Support or ask on their user forum with an example Project attached.
Further more I'm not sure what you would mean my Cmax2 and Tmax2; there can only be one maximum... (and if there are two values *exactly* the same in a dosing profile, then NCA will report the first occurence).
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Posting: # 19520
» Further more I'm not sure what you would mean my Cmax2 and Tmax2; there can only be one maximum...
Haha, „There can be only one” of the Highlander? For multiphasic or pulsatile MR products the EMA wants a pre-specified cut-point for the AUC (like the FDA does). So far, so good.
In its eternal wisdom the EMA wants not only the (global) Cmax but also the Cmax within each interval (GL Section 188.8.131.52).
@Robin: Trivial in Phoenix. Perform NCA on the entire data set (PHX will do the interpolation of pAUCs if actual times ≠ scheduled times). Split the original data set by the cut-off time (scheduled, not actual time). Run NCA on both (deselect everything except Cmax and tmax). Rename Cmax to Cmax1, Cmax2. Join or merge the results.
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