The Rule of 5 methodology appears to be as useful today in defining drugability as when it
was proposed, but recognizing that the database that we used includes only drugs that …

The recent impact of the Biopharmaceutics Classification System (BCS) and the
Biopharmaceutics Drug Disposition Classification System (BDDCS) on relevant scientific …

In vitro chemical safety testing methods offer the potential for efficient and economical tools
to provide relevant assessments of human health risk. To realize this potential, methods are …

Abstract Next-Generation Risk Assessment is defined as an exposure-led, hypothesis-driven
risk assessment approach that integrates new approach methodologies (NAMs) to assure …

Nominal effect concentrations from in vitro toxicity assays may lead to inaccurate estimations
of in vivo toxic doses because the nominal concentration poorly reflects the concentration at …

Predicting transporter-based drug clearance (CL) and tissue concentrations (TC) in humans
is important to reduce the risk of failure during drug development. In addition, when …

Passive permeability is a key property in drug disposition and delivery. It is critical for
gastrointestinal absorption, brain penetration, renal reabsorption, defining clearance …

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

Due to its implications for both dose level and frequency, clearance rate is one of the most
important pharmacokinetic parameters to consider in the design of drug candidates …

Although prediction of clearance using hepatocytes and liver microsomes has long played a
decisive role in drug discovery, it is widely acknowledged that reliably accurate prediction is …