Pharmacokinetics (PK) is the study of the absorption, distribution, metabolism, and excretion
(ADME) processes of a drug. Understanding PK properties is essential for drug development …

Physiologically based pharmacokinetic (PBPK) modeling and simulation can be used to
predict the pharmacokinetic behavior of drugs in humans using preclinical data. It can also …

This commentary provides an update on the status of physiologically based pharmacokinetic
modeling and simulation at the US Food and Drug Administration's Office of Clinical …

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

The US Food and Drug Administration (FDA) public workshop, entitled “Application of
Physiologically‐based Pharmacokinetic (PBPK) Modeling to Support Dose Selection …

There is a renewed surge of interest in applications of physiologically-based
pharmacokinetic (PBPK) models by the pharmaceutical industry and regulatory agencies …

Drug metabolism and pharmacokinetics (DMPK) is an important branch of pharmaceutical
sciences. The nature of ADME (absorption, distribution, metabolism, excretion) and PK …

Model‐informed drug development (MIDD) is a powerful quantitative approach that plays an
integral role in drug development and regulatory review. While applied throughout the life …

Physiologically based pharmacokinetic (PBPK) modeling and physiologically based
biopharmaceutics modeling (PBBM) are invaluable tools with wide applications during drug …

Physiologically based pharmacokinetic (PBPK) modeling is a valuable tool in drug
development and regulatory assessment, as it offers the opportunity to simulate the …