Efficient drug development of oseltamivir capsules based on process control, bioequivalence and PBPK modeling.

Oseltamivir phosphate is used to treat influenza. For registration of a generic product, bioequivalence studies are crucial, however, studies can sometimes replace the conventional human pharmacokinetic. To assess whether the dissolution profile is comparable with the release, physiologically based pharmacokinetic absorption models (PBPK) are being used.