Formulation and Quality – Chemical
Predicting in vivo performance of pharmaceutical products is a key a challenge for scientists working in the pharmaceutical sciences field. Currently, there are no in vitro or in silico tools available that can accurately predict the PK behavior of a new drug substance due to complex in vivo steps the drug substance encounters once ingested and finally eliminated. What can be done today though by applying in vitro dissolution testing combined with dissolution modeling is to anticipate differences in PK performance which can be used to guide formulation candidate selection and bioperformance risk assessment throughout product development. To be truly predictive, one must measure PK performance and then establish a link to in vitro data. Different in vitro approaches to guide formulation candidate selection and to predict in vitro dissolution performance will be presented along with current challenges to develop predictive dissolution models for IR products.