Applications of IVIVC in Formulation Development - PQRI

FDA Guidance on Development, Evaluation
and Application of IVIVCs
Traditional Approach
“Level A Correlation is . . . . comparison of fraction of drug absorbed to the fraction
of drug dissolved”
“release rates, as measured by percent dissolved, for each formulation studied,
should differ adequately (e.g., 10%)”
“most commonly seen processes”
Non-traditional Approach
“Alternative approaches to developing Level A IVIVCs are possible”
“Whatever the method used to establish a Level A IVIVC, the model should predict
the entire in vivo time course from the in vitro data. In this context, the model refers
to the relationship between in vitro dissolution of an ER dosage form and an in vivo
response such as plasma drug concentration or amount of drug absorbed”
“Release rate: Amount of drug released per unit time as defined by in vitro or in vivo
testing”