This section details the equations that define and support a Level A IVIVC, which is a specific category of IVIVC that you can carry out in the optional Drug-Drug Interaction (DDI) module. See:
For details about the internal standards that were used to define the equations in this section, see Equation Standards.
Level A IVIVC Deconvolution Equations
Equation 5-1: Wagner-Nelson deconvolution method, 1-compartment PK model
where:
|
Variable |
Definition |
|
|
The amount (mass) of the drug at time t. |
|
|
The volume of distribution of the drug. |
|
|
The concentration of the drug in plasma at time t. |
|
|
The elimination rate of the drug. |
|
|
The concentration of the drug. |
Equation 5-2: Loo-Riegelman deconvolution method, 2-compartment PK model (i)
where:
|
Variable |
Definition |
|
|
The amount (mass) of the drug at time T. |
|
|
The volume of distribution of the drug. |
|
|
The concentration of the drug in plasma at time T. |
|
|
The elimination rate of the drug. |
|
|
The concentration of the drug. |
|
|
The rate constant for the transfer of the drug from compartment 1 to compartment 2. |
|
|
The rate constant for the transfer of the drug from compartment 2 to compartment 1. |
Equation 5-3: Loo-Riegelman deconvolution method, 2-compartment PK model (ii)
where:
|
Variable |
Definition |
|
|
The amount (mass) of the drug at time T. |
|
|
The volume of distribution of the drug. |
|
|
The concentration of the drug in plasma at time T. |
|
|
The elimination rate of the drug. |
|
|
The concentration of the drug. |
|
|
The rate constant for the transfer of the drug from compartment 1 to compartment 2. |
|
|
The rate constant for the transfer of the drug from compartment 2 to compartment 1. |
|
|
The rate constant for the transfer of the drug from compartment 1 to compartment 3. |
|
|
The rate constant for the transfer of the drug from compartment 3 to compartment 1. |
Equation 5-4: Shifting and scaling function for the mechanistic deconvolution method
where:
|
Variable |
Definition |
|
|
The fraction in vivo dissolution. |
|
|
The fraction in vitro dissolution. |
|
|
The release scale coefficient. |
|
|
The release shift coefficient. |
|
|
The time scale coefficient. |
|
|
The time shift coefficient. |