An interesting question about drug dissolution testing and simulation/modelling:

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?

Very good question!
In this respect, one should make sure that apparatus/method used for dissolution testing purposes 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 then should be applied to the test products. Scientifically validation cannot be achieved using products under development (

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