Defining time to concentration threshold [General Statistics]
I am planning a study where I want to include the time until a pre-defined plasma concentration threshold is reached as a PK parameter. Two options/methods for defining this parameter has been discussed:
- The simplest approach would be to use the first sampling time-point where the concentration exceeds the threshold.
- The other approach would be to use linear interpolation to find a more precise estimate of the time the concentration actually crosses the threshold.
- Option A requires no imputation/assumptions of plasma levels between samples.
- Data based on actual sampling times will be analogous to Tmax and perhaps more recognizable/acceptable by the authorities.
- I also plan to present the percentage of subjects exceeding the threshold value at each sampling timepoint. A definition according to option A would better correspond with this analysis.
- Is there a "standard" approach?
- Does anyone have any advice on the best approach or experience regarding regulatory acceptability of data?
- Defining time to concentration thresholdCytokrom C 2022-04-29 16:24 [General Statistics]