In vitro and in vivo data must be in separate datasets. Individual functions are specified and run in the separate panels and tabs of the IVIVC object.
In vitro data, in vivo data, and dosing data should be similarly scaled for a successful IVIVC (see the “IVIVC workflow example” for an example of a full IVIVC workflow).
Phoenix IVIVC uses a two-stage Level A correlation, where deconvolution is followed by a linear correlation model representing a relationship between in vitro dissolution and in vivo input rate. The in vitro dissolution and in vivo input curves should be directly superimposable or be made superimposable by using a scaling factor (see FDA 1997 Guidance on IVIVC) or by changing units to convert data appropriately.
For example, specifying in vivo dosing as a very large value will result in large input rates from deconvolution. If dissolution data is then given in small-scale numbers, Level A IVIVC may fail to produce accurate results due to numerical instabilities, particularly Convolution in the prediction stage may fail to produce non-zero concentrations. The dosing data in this case should be scaled by using larger units (e.g., convert ng to mg) in order for the input rates to be consistently scaled with the dissolution data.
If the data for a step is fed into the workflow (e.g., through a data link), executing the IVIVC step from the step’s properties panel will not execute the source feeder and can lead to a “lack of source” error. If this occurs, execute the full IVIVC workflow object to ensure that sources are executed prior to the IVIVC workflow validation.
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