If you are using a composite profile to generate PK parameter estimates for NCA, do you use data where one or more animals is missing data? For example, if you have the following samples available (missing samples BLQ)
Time (h) 0 1 2 3 4 5 6 7 8
N 3 3 3 3 3 3 3 2 1
Should you exclude the 7 or 8 hour timepoints as there is data missing, or should you include it? The Sparse sampling option for NCA includes N and SEM estimates in the output, but is it still appropriate to use the later timepoints in lambda z ranges?
Is there any regulatory guidance on this issue?
Any advice would be great.