Although oral drug delivery is the preferred administration route and has been used for
centuries, modern drug discovery and development pipelines challenge conventional …

The use of physiologically based pharmacokinetic (PBPK) modeling to support the drug
product quality attributes, also known as physiologically based biopharmaceutics modeling …

For oral drug products, in vitro dissolution is the most used surrogate of in vivo dissolution
and absorption. In the context of drug product quality, safe space is defined as the …

Highlights•PBPK modeling bridges drug properties and PK behaviours in drug discovery
and development.•The PBPK is often used in oral formulation development, to address …

Physiologically based biopharmaceutics modeling (PBBM) emphasizes the integration of
physicochemical properties of drug substance and formulation characteristics with system …

Quality risk assessment following ICH Q9 principles is an important activity to ensure optimal
clinical efficacy and safety of a drug product. Typically, risk assessment is focused on …

Physiologically based pharmacokinetic (PBPK) absorption modeling and simulation is
increasingly used as a tool in drug product development, not only in support of clinical …

For over 15 years, US and EU regulations ensure that medicines developed for children are
explicitly authorised for such use with age-appropriate forms and formulations, implying …

Objective A physiologically based biopharmaceutics model (PBBM) was developed to
mechanistically investigate the effect of formulation and food on selumetinib …

To date, mechanistic modeling of oral drug absorption has been achieved via the use of
physiologically based pharmacokinetic (PBPK) modeling, and more specifically …