NonParametric Superposition methodology

NonParametric superposition assumes that each dose of a drug acts independently of every other dose; that the rate and extent of absorption and average systemic clearance are the same for each dosing interval; and that linear pharmacokinetics apply, so that a change in dose during the multiple dosing regimen can be accommodated.

To predict the drug concentration resulting from multiple doses, one must have a complete characterization of the concentration-time profile after a single dose. That is, it is necessary to know C(t_i) at sufficient time points t_i, (i=1,2,…,n), to characterize the drug absorption and elimination process. Two assumptions about the data are required: independence of each dose effect, and linearity of the underlying pharmacokinetics. The former assumes that the effect of each dose can be separated from the effects of other doses. The latter, linear pharmacokinetics, assumes that changes in drug concentration will vary linearly with dose amount.

The required input data are the time, dosing, and drug concentration. The drug concentration at any particular time during multiple dosing is then predicted by simply adding the concentration values as shown in the next section (“Computation method”).

Note:    User-defined terminal phases apply to all sort keys. In addition, dosing schedules and doses are the same for all sort keys.

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