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 …

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 …

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

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 …

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 …

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

Background: In January 2020, the US FDA published two final guidelines, one entitled “In
vitro Drug Interaction Studies-Cytochrome P450 Enzyme-and Transporter-Mediated Drug …

For successful oral drug development, defining a bioequivalence (BE) safe space is critical
for the identification of newer bioequivalent formulations or for setting of clinically relevant in …