Bioequivalence and Bioavailability Forum

Hi Ashima,

BTW, are you referring to this guideline?

❝ But I want to know t50% AUC(0-8h) (time to 50% of AUC, and my last sample was scheduled at 8 hours).

Just to clarify: Are you interested in the yellow area?

Doesn’t look like your GIR cause that’s a PK profile but you get the idea. IIRC, this was called AUC_apical by the “Two Lászlós” (Endrényi and Tóthfalusi). Have to dig it out.

Or this one?

❝ So next what should I do if I know HVD?

Both are not easy to calculate because HVD is the difference between the two intersections times which you don’t get in Phoenix. I suggest to register at Certara’s forum and post an example project containing the data of one subject.

Ideas:

• Modify one of the R-scripts of this thread and call them from Phoenix.
  
• Preliminary NCA (where we calculated 50%C_max and 75%C_max) > Final Parameters Pivoted > Data Wizard > Exclude Cmax_75
  Custom Function: New Column Name: Baseline, Formula: 0
  Properties: Cmax > Max_Response, Cmax_2 > Threshold
  Rename the Data Wizard to PD limits
  Set up another NCA-object > Options > Model Type Drug Effect (220)
  Therapeutic Response > Drag/drop the Results of PD limits (the mapping should be recognized)
  When you execute the NCA-Object you get
  AUC_Above_T
AUC_Below_T
AUC_Net_T
  I have to figure out which is what (in my example the last was negative).