In the life cycle of drug product development, several types of biorelevant dissolution data are generated (single stage, 2-stage, ASD, etc.) to aid formulation development. These dissolution data are also used in PBPK models.
What type of in vitro biorelevant dissolution methods do you use as input in PBPK modeling?
Can there be a general decision tree on the use of types of biorelevant dissolution data in PBPK models for applications in formulation selection?
That is a very good question!
In this respect, one should ensure that the apparatus/method used for dissolution testing should be validated first. It is important to note that, at present, none of the apparatuses/methods have been validated. For validation purposes, the apparatuses/methods are to be validated independently using a reference product with known dissolution characteristics, which should be applied to the test products. Scientifically validation cannot be achieved using products under development (Link).