In recent decades pharmaceutics and drug delivery have become increasingly critical in the
pharmaceutical industry due to longer time, higher cost, and less productivity of new …

Several regulatory guidances on the use of physiologically based pharmacokinetic (PBPK)
analyses and physiologically based biopharmaceutics model (s)(PBBM (s)) have been …

During the past few decades, the science of toxicology has been undergoing a
transformation from observational to predictive science. New approach methodologies …

We assess the advancement of physiologically based pharmacokinetic (PBPK) modeling
and simulation (M&S) over the last 20 years (start of 2000 to end of 2019) focusing on the …

Converting student theses or final projects into publishable articles poses a significant
challenge. Many students struggle to articulate their ideas in scientific publications due to a …

Many drug–drug interactions (DDI s) are based on alterations of the plasma concentrations
of a victim drug due to another drug causing inhibition and/or induction of the metabolism or …

Developmental changes in children can affect the disposition and clinical effects of a drug,
indicating that scaling an adult dose simply down per linear weight can potentially lead to …

The predictive performance of physiologically‐based pharmacokinetics (PBPK) models for
pharmacokinetics (PK) in renal impairment (RI) and hepatic impairment (HI) populations was …

Phase 0 approaches—which include microdosing—evaluate subtherapeutic exposures of
new drugs in first-in-human studies known as exploratory clinical trials. Recent progress …

Physiologically‐based pharmacokinetic (PBPK) modeling has been extensively used to
quantitatively translate in vitro data and evaluate temporal effects from drug–drug …